Subset Code	Subset Name	Concept Code	NCIt Preferred Term	NCIt Definition	PQCMC Preferred Term	PQCMC Synonyms(s)	PQCMC Definition
C133807	PQ/CMC Test Category Terminology	C103201	Optical Rotation	The ability of a chiral substance to rotate the plane of polarization of a beam of transmitted plane-polarized light, either clockwise (to the right) or counterclockwise (to the left).	Optical Rotation		A property of many pharmaceutical substances to rotate an incident plane of polarized light so that the transmitted light emerges at a measurable angle to the plane of the incident light.
C133807	PQ/CMC Test Category Terminology	C133961	Deliverable Volume/Fill Volume Test	Tests designed to provide assurance that the liquids will, when transferred from the original container, deliver the volume of dosage form that is declared on the label of the article.	Deliverable Volume/Fill Volume		Tests designed to provide assurance that oral liquids will, when transferred from the original container, deliver the volume of dosage form that is declared on the label of the article.
C133807	PQ/CMC Test Category Terminology	C133974	Crystallinity Analysis	The detection and quantification of the amount of amorphous material within a highly crystalline substance.	Crystallinity		The detection and/or quantification of the amount of amorphous material within a highly crystalline substance.
C133807	PQ/CMC Test Category Terminology	C133975	Tablet Friability Determination	The percent loss of a tablet due to mechanical action that results in fracture or breaking during the test.	Friability		The percent loss of a tablet due to mechanical action that results in fracture or breaking during the test
C133807	PQ/CMC Test Category Terminology	C133979	Viscosity/Rheological Property Analysis	The determination of the thickness of a fluid and other properties related to the flow of a material.	Viscosity/Rheological Properties		Tests to measure a property of liquids that is closely related to the resistance to flow.
C133807	PQ/CMC Test Category Terminology	C133983	Pyrogenicity/Endotoxin Assessment	Tests to measure the ability of a substance to produce an endotoxin or febrile and/or inflammatory reaction in response to administration of a substance.	Pyrogenicity/Endotoxin		Tests designed to limit to an acceptable level the risks of febrile reaction in the patient to the administration, by injection, of the product concerned. The test involves measuring the rise in temperature of rabbits following the intravenous injection of a test solution and is designed for products that can be tolerated by the test rabbit in a dose not to exceed 10 mL/kg injected intravenously within a period of NMT 10 min.
C133807	PQ/CMC Test Category Terminology	C133985	Redispersibility Measurement	A measurement of the time necessary for settled components to remix uniformly.	Redispersibility		Testing of oral suspensions that settle on storage (produce sediment) to measure the time required to achieve resuspension.
C133807	PQ/CMC Test Category Terminology	C134113	Syringe Functionality Testing	Testing a syringe to verify it functions properly.	Syringe Functionality		Tests performed on syringes to ensure that It operates as specified.
C133807	PQ/CMC Test Category Terminology	C134114	Total Organic Carbon Measurement	An indirect measure of organic molecules present in pharmaceutical waters measured as carbon.	Total Organic Carbon		An indirect measure of organic molecules present in pharmaceutical waters measured as carbon.
C133807	PQ/CMC Test Category Terminology	C134249	Container Closure Integrity Testing	An assessment of the structural characteristics of the container closure system to ensure the required specifications for integrity are met.	Container Closure Integrity		Tests for the adequacy of pharmaceutical packaging and container closures.
C133807	PQ/CMC Test Category Terminology	C134250	Content Uniformity Test	An assessment of the quality of the sameness of the contents of a substance.	Uniformity		Tests to ensure the consistency of the API in the formulation. Test may be done as an IPC, release, or stability test.
C133807	PQ/CMC Test Category Terminology	C134252	Pharmaceutical Disintegration Test	Test to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.	Disintegration		Test to determine whether tablets capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.
C133807	PQ/CMC Test Category Terminology	C134253	Pharmaceutical Dissolution Test	Test to determine compliance with the requirements of the material of interest dissolving into solution.	Dissolution		Test to determine compliance with the requirements of the material of interest dissolving into solution.
C133807	PQ/CMC Test Category Terminology	C134255	Loss on Drying Measurement	The determination of the total change in weight of a material as a result of drying. It determines the moisture content of a sample	Loss on Drying		Analytical procedures to determine the amount of volatile matter of any kind that is driven off under the conditions specified.
C133807	PQ/CMC Test Category Terminology	C134256	Microbial Limit Determination	An assessment of the total number of viable aerobic microorganisms present in a product and the semi-quantitative estimation of the relative number of specific types of microbes present based on an established specification for production quality.	Microbial Limits		Tests for the estimation of the number of viable aerobic microorganisms present and for the freedom from designated microbial species in the pharmaceutical articles of all kinds, from raw materials to the finished forms.
C133807	PQ/CMC Test Category Terminology	C134257	Particle Size Distribution Analysis	Analytical procedures that utilize mechanical sieving for deducing the particle-size distribution of a powdered solid.	Particle Size Distribution		Analytical procedures that utilize mechanical sieving for deducing the particle-size distribution of a powdered solid.
C133807	PQ/CMC Test Category Terminology	C134260	Powder Bulk Density Measurement	The ratio of the mass of an untapped powder sample and its volume including the contribution of the interparticulate void volume.	Bulk Density		Tests that determine the ratio of the mass of an untapped powder sample and its volume including the contribution of the interparticulate void volume.
C133807	PQ/CMC Test Category Terminology	C134263	Conductivity Measurement	A measure of the ion-facilitated electron current through a material.	Conductivity		Electrical conductivity is a measure of the ion-facilitated electron flow through it.
C133807	PQ/CMC Test Category Terminology	C134264	Hardness Measurement	The determination of the breaking point and structural integrity of a material.	Hardness		A test used to identify the ability of a material to resist mechanical deformation such as scratching or penetration by other substances.
C133807	PQ/CMC Test Category Terminology	C134266	Tap Density Determination	Determination of the density, compared to the bulk density, of dry particles, expressed in mass/volume, obtained by mechanically tapping a cylinder containing the powder sample until no more change in volume occurs.	Tap Density		An increased bulk density attained after mechanically tapping the container containing the powder sample. (aka - tapped density)
C133807	PQ/CMC Test Category Terminology	C134267	Plume Geometry Test	A test that measures the spray pattern characteristics, including shape and size of the evolving spray cloud under defined experimental and instrumental test conditions.	Plume Geometry		A test that measures the spray pattern characteristics, including shape and size of the evolving spray cloud under defined experimental and instrumental test conditions.
C133807	PQ/CMC Test Category Terminology	C134269	Polymorphic Form Determination	Tests to determine the crystalline form of a particular solid material.	Polymorphism		Tests to determine the different crystalline forms of a given drug substance
C133807	PQ/CMC Test Category Terminology	C134270	Potency Assay	The determination of the strength of a material, as measured by the ability to produce a specific response. The potency of a pharmacologic substance is measured by the amount needed to produce a certain effect.	Potency		Tests to measure the biological activity using a suitably quantitative biological assay (also called potency assay or bioassay), based on the attribute of the product which is linked to the relevant biological properties.
C133807	PQ/CMC Test Category Terminology	C134272	Reconstitution Time Measurement	Measurement of how long it takes to restore something dried to its original state of liquid.	Reconstitution Time		Measurement of how long it takes to restore something dried to its original state of liquid.
C133807	PQ/CMC Test Category Terminology	C134276	Residue on Ignition Measurement	The amount of residual substance not volatilized after a sample is ignited.	Residue on Ignition		Tests to measure the amount of residual substance not volatilized from a sample when the sample is ignited in the presence of sulfuric acid. This test is usually used for determining the content of inorganic impurities in an organic substance.
C133807	PQ/CMC Test Category Terminology	C134277	Spray Pattern Assessment	Tests to determine the size of the mist formed by spraying. The measurement is made for the longest axis (x axis), and the ratio of longest to shortest axes (x/y ratio).	Spray Pattern		Tests to determine the size of the mist formed by spraying. The measurement is made for the longest axis (x axis), and the ratio of longest to shortest axes (x/y ratio).
C133807	PQ/CMC Test Category Terminology	C134278	Sterility Test	Tests done under aseptic conditions to ensure that there are no contaminating micro-organism present in the sample.	Sterility		Tests done under aseptic conditions to ensure that there are no contaminating micro-organism present in the sample.
C133807	PQ/CMC Test Category Terminology	C138993	Material Identification Test	Tests that establishes the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present.	Identification		Tests that establish the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present.
C133807	PQ/CMC Test Category Terminology	C18951	Post Translational Modification Analysis	Laboratory procedures used for the analysis of the processing events of a protein after its translation from messenger RNA in order to gain insight into biological function. These include mass spectrometric peptide sequencing and analysis technologies.	Post-translational Modifications		Test to measure if the protein undergoing post translational modification which include glycosylation etc.
C133807	PQ/CMC Test Category Terminology	C193381	Particulate Testing	Analysis of particulate or foreign material returned from user for evaluation.	Foreign and Particulate Matter		Tests for injections or infusions to check for insoluble particles to confirm that they are not present in excess of specified levels in the solutions.
C133807	PQ/CMC Test Category Terminology	C200004	Cytotoxicity Assay	A laboratory assessment to determine cytotoxicity (induction of cell death) as the result of in vivo or in vitro exposure to test article.	Cytotoxicity		Test methods designed to evaluate the acute adverse biological effects of extractables from medical device materials.
C133807	PQ/CMC Test Category Terminology	C204971	Impurity Test	Analytical procedures to establish material purity by determining the presence of a material or component that is not defined as the material.	Impurity		Analytical procedures to establish material purity by determining the presence of a material or component of a material that is not defined as the material.
C133807	PQ/CMC Test Category Terminology	C205000	Active Substance Functional Assay	Assay to quantify functioning of an active substance to a specific disease.	Functional Assays		Functional assay used to quantify functioning of an active substance rather than just its quantity. Common uses are: showing that a drug target fits the desired functionality and quality profile before moving on to the next stage of development; and comparison of biosimilars with innovator products.
C133807	PQ/CMC Test Category Terminology	C205012	Droplet Size Test Measurement	Tests that determine the size of the liquid drop.	Droplet Size		Tests that determine the size of the liquid drop.
C133807	PQ/CMC Test Category Terminology	C205013	Elemental Analysis	A qualitative and/or quantitative analytical chemistry methodology used to determine which elements are present in a test sample.	Elemental Analysis		The relative proportion of elements present in a sample.
C133807	PQ/CMC Test Category Terminology	C205023	Mechanical Integrity Test	Test that measures what amount of force is needed to alter the mechanical integrity of a construct.	Mechanical Integrity		Test that measures what amount of force is needed to alter the mechanical integrity of a construct.
C133807	PQ/CMC Test Category Terminology	C205026	Organoleptic Examination	Evaluation via the senses.	Organoleptic		Evaluation via the senses—including taste, sight, smell, and touch.
C133807	PQ/CMC Test Category Terminology	C205027	Osmolality/Osmolarity Measurement	Measurements of the solute concentration of a solution; expressed in terms of either the weight of the solvent or the solvent volume.	Osmolality/Osmolarity		Osmolality and osmolarity are measurements of the solute concentration of a solution. Osmolality is expressed in terms of the weight of the solvent and osmolarity is expressed in terms of solvent volume.
C133807	PQ/CMC Test Category Terminology	C205029	pH Measurement	The measure of acidity or alkalinity of an aqueous solution.	pH		The measure of acidity or alkalinity of an aqueous solution.
C133807	PQ/CMC Test Category Terminology	C205030	Porosity Measurement	The measurement of the empty spaces/voids in a material.	Porosity		Tests that measure the empty spaces/voids in the material.
C133807	PQ/CMC Test Category Terminology	C205032	Refractive Index Measurement	A determination of the refractive index of a sample, defined by the ratio of the speed of light in a vacuum divided by the speed of light in a test sample.	Refractive Index		Tests performed to determine the ratio of velocity of light in air to the velocity of light in the substance.
C133807	PQ/CMC Test Category Terminology	C205041	Surface Area Measurement	Total surface area of a 2D or 3D material.	Surface Area		Total surface area of a 2D or 3D material.
C133807	PQ/CMC Test Category Terminology	C205049	Transdermal Device Property Test	Tests that determine the physical properties of transdermal systems.	Transdermal Properties		Tests that determine the physical properties of transdermal systems. Example: Peel adhesion test, Tack test, Cold Flow test, etc.
C133807	PQ/CMC Test Category Terminology	C25483	Dimension	The magnitude of something in a particular direction, especially length or width or height.	Material Properties/Measurements		Dimensions and physical properties of the material of interest including tablets, capsule, soft gel capsule, granulate or pellet, etc.
C133807	PQ/CMC Test Category Terminology	C60819	Assay	A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties of a drug.	Assay		A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties of a drug.
C133807	PQ/CMC Test Category Terminology	C60821	Solubility	The ability of a particular substance to dissolve in a particular solvent (yielding a saturated solution).	Solubility		A chemical property referring to the ability for a given substance, the solute, to dissolve in a solvent. It is measured in terms of the maximum amount of solute dissolved in a solvent at equilibrium.
C133807	PQ/CMC Test Category Terminology	C63394	Melting Point Determination	Determining the temperature at which a crystalline solid changes state from solid to liquid.	Melting Point		The temperature at the which a substance changes from solid to a liquid state at atmospheric pressure.
C133807	PQ/CMC Test Category Terminology	C64832	Specific Gravity	The density (mass per unit volume) of any material divided by that of water at a standard temperature.	Specific Gravity		The ratio of the density of any substance to the density of some other substance taken as standard, water being the standard for liquids and solids, and hydrogen or air being the standard for gases.
C133807	PQ/CMC Test Category Terminology	C74723	Turbidity Measurement	The determination of the opacity of a sample.	Turbidity		Measurement of the clarity and degree of opalescence of liquids by comparison of the solutions in diffused daylight after preparation of the reference suspension.
C133846	PQ/CMC Batch Utilization Terminology	C133990	Commercial Batch	A product batch intended for marketing.	Commercial		A product batch intended for marketing.
C133846	PQ/CMC Batch Utilization Terminology	C133991	Development Batch	A batch produced during the characterization and process definition for the desired product.	Development		A batch produced during the characterization and process definition for the desired product.
C133846	PQ/CMC Batch Utilization Terminology	C133992	Clinical Batch	A batch produced for use in clinical trials.	Clinical		A batch produced for use in clinical trials.
C133846	PQ/CMC Batch Utilization Terminology	C133993	Validation Batch	A batch intended for use in verification and demonstration of suitability of the designed process.	Validation		A batch intended for use in verification and demonstration of suitability of the designed process.
C133846	PQ/CMC Batch Utilization Terminology	C133994	Bioequivalence Batch	A batch produced and used for the purposes of determining bioequivalence of the product.	Bioequivalence		A batch produced and used for the purposes of determining bioequivalence of the product.
C133846	PQ/CMC Batch Utilization Terminology	C185328	Stability Study Batch	A batch placed under study to determine the maintained performance parameters over time.	Stability Study		A batch placed under study to determine the maintained performance parameters over time.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133910	MDL Molfile Format	A chemical text file format developed by Molecular Design Limited (MDL) that represent information about molecular atoms, bonds, connectivity and coordinates. The file extension is .mol.	MOLFILE		A chemical text file format developed by Molecular Design Limited (MDL) that represent information about molecular atoms, bonds, connectivity and coordinates. The file extension is .mol.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133996	MDL Structure-data File Format	A family of chemical text file formats developed by Molecular Design Limited (MDL) that represent multiple chemical structural records and associated data fields. The file extension is .sd or .sdf.	SDF		A family of chemical text file formats developed by Molecular Design Limited (MDL) that represent multiple chemical structural records and associated data fields. The file extension is .sd or .sdf.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133997	Macromolecular CIF	A standard text file format for representing crystallographic information of large molecules. The file extension is .mcif.	mmCIF (large molecules)		A standard text file format for representing crystallographic information of large molecules. The file extension is .mcif.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C49039	Protein Data Bank	A worldwide repository for the processing and distribution of 3-D biological macromolecular structure data.	PDB		A worldwide repository for the processing and distribution of 3-D biological macromolecular structure data.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C54683	International Chemical Identifier	A textual identifier for chemical substances designed to provide a standard and human-readable way to encode molecular information that also facilitates searches in printed and electronic data sources.	InChI File (small molecule)		A textual identifier for chemical substances designed to provide a standard and human-readable way to encode molecular information that also facilitates searches in printed and electronic data sources.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C54684	Simplified Molecular Input Line Entry Specification	Specification for unambiguously describing the structure of chemical molecules using short ASCII strings. SMILES strings can be imported by most molecular editors for conversion back into two-dimensional drawings or three-dimensional models for the molecules.	SMILES		Specification for unambiguously describing the structure of chemical molecules using short ASCII strings. SMILES strings can be imported by most molecular editors for conversion back into two-dimensional drawings or three-dimensional models for the molecules.
C133848	PQ/CMC Chemical Structure Data File Type Terminology	C85435	Scalable Vector Graphics	A specification for describing vector graphics using extensible markup language.	SVG		A specification for describing vector graphics using extensible markup language.
C133849	PQ/CMC Closure Type Terminology	C96113	Child Resistant Metal Container Closure	Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.	Child-resistant, Metal		Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.
C133849	PQ/CMC Closure Type Terminology	C96114	Child Resistant Plastic Container Closure	Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.	Child-resistant, Plastic		Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.
C133849	PQ/CMC Closure Type Terminology	C96115	Continuous Thread Metal Container Closure	Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.	Continuous Thread, Metal		Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.
C133849	PQ/CMC Closure Type Terminology	C96116	Continuous Thread Plastic Container Closure	Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.	Continuous Thread, Plastic		Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.
C133849	PQ/CMC Closure Type Terminology	C96117	Tamper Evident Metal Container Closure	A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal).	Tamper-evident, Metal		A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal).
C133849	PQ/CMC Closure Type Terminology	C96118	Tamper Evident Plastic Container Closure	A closure that shows the package has been opened and the product has been exposed to the outside environment.	Tamper-evident, Plastic		A closure that shows the package has been opened and the product has been exposed to the outside environment.
C133849	PQ/CMC Closure Type Terminology	C96119	Vacuum Sealed Metal Container Closure	Metal closures used on packages where the pressure inside the package is less than atmospheric.	Vacuum, Metal		Metal closures used on packages where the pressure inside the package is less than atmospheric.
C133849	PQ/CMC Closure Type Terminology	C96120	Tamper Evident Composite Container Closure	Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened.	Tamper-evident, Composite		Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened.
C133849	PQ/CMC Closure Type Terminology	C96121	Vacuum Sealed Plastic Container Closure	Plastic closures used on packages where the pressure inside the package is less than atmospheric.	Vacuum, Plastic		Plastic closures used on packages where the pressure inside the package is less than atmospheric.
C133849	PQ/CMC Closure Type Terminology	C96122	Vacuum Sealed Composite Container Closure	Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric.	Vacuum, Composite		Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric.
C133849	PQ/CMC Closure Type Terminology	C96123	Press-On/Twist-Off Metal Container Closure	Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal.	Press-on/twist-off, Metal		Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal.
C133849	PQ/CMC Closure Type Terminology	C96124	Press-On Composite Container Closure	A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes.	Press-on, Composite		A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes.
C133849	PQ/CMC Closure Type Terminology	C96125	Crown Metal Container Closure	A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4" high when manufactured and does not have a rolled edge or wire. The crown is manufactured 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish.	Crown, Metal		A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4\ high when manufactured and does not have a rolled edge or wire. The crown is manufactured 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish.
C133849	PQ/CMC Closure Type Terminology	C96126	Lug Metal Container Closure	Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application.	Lug, Metal		Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application.
C133849	PQ/CMC Closure Type Terminology	C96127	Roll On Metal Container Closure	A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread.	Roll-on, Metal		A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread.
C133849	PQ/CMC Closure Type Terminology	C96128	Flip-Top Dispensing Plastic Container Closure	A hinged single or dual flap closure for controlled product dispensing.	Flip-Top (Dispensing), Plastic		A hinged single or dual flap closure for controlled product dispensing.
C133849	PQ/CMC Closure Type Terminology	C96129	Hinged Dispensing Plastic Container Closure	A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice.	Hinged (Dispensing), Plastic		A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice.
C133849	PQ/CMC Closure Type Terminology	C96130	Linerless Plastic Container Closure	A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish.	Linerless, Plastic		A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish.
C133849	PQ/CMC Closure Type Terminology	C96131	Pump Dispensing Plastic Container Closure	Closure dispensing pumps are used to dispense product from containers.	Pump (Dispensing), Plastic		Closure dispensing pumps are used to dispense product from containers.
C133849	PQ/CMC Closure Type Terminology	C96132	Push-Pull Dispensing Plastic Container Closure	A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway.	Push-pull (Dispensing), Plastic		A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway.
C133849	PQ/CMC Closure Type Terminology	C96133	Snap-On Cap Plastic Container Closure	A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package.	Snap-on Cap, Plastic		A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package.
C133849	PQ/CMC Closure Type Terminology	C96134	Snip-Tip Dispensing Plastic Container Closure	Conical closure that is turned onto a container. The tip is cut off to open the container.	Snip-tip (Dispensing), Plastic		Conical closure that is turned onto a container. The tip is cut off to open the container.
C133849	PQ/CMC Closure Type Terminology	C96135	Toggle-Swing Dispensing Plastic Container Closure	A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position.	Toggle-swing (Dispensing), Plastic		A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position.
C133849	PQ/CMC Closure Type Terminology	C96136	Trigger Spray Dispensing Plastic Container Closure	Closure designed to dispense product from containers by spraying the product when a trigger is pulled.	Trigger Sprayer (Dispensing), Plastic		Closure designed to dispense product from containers by spraying the product when a trigger is pulled.
C133849	PQ/CMC Closure Type Terminology	C96137	Twist Open/Close Dispensing Plastic Container Closure	Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container.	Twist Open/Close (Dispensing), Plastic		Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container.
C133849	PQ/CMC Closure Type Terminology	C96138	Valved Dispensing Plastic Container Closure	Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open.	Valved (Dispensing), Plastic		Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open.
C133849	PQ/CMC Closure Type Terminology	C96139	Stopper Container Closure	Object used to plug opening of container.	Stopper		Object used to plug opening of container.
C133849	PQ/CMC Closure Type Terminology	C96140	Tie Container Closure	Line, ribbon, or cord used for fastening, or drawing the container closed.	Tie		Line, ribbon, or cord used for fastening, or drawing the container closed.
C133851	PQ/CMC Conformance to Criteria Terminology	C133998	Does Not Conform	An observation that the item of interest does not match required specifications.	Does not conform		An observation that the item of interest does not match required specifications.
C133851	PQ/CMC Conformance to Criteria Terminology	C80262	Conformance	Correspondence in form or appearance.	Conforms		Correspondence in form or appearance.
C133852	PQ/CMC Container Orientation Terminology	C133914	Valve-up	A position in which the valve indicator is pointing up.	Valve-up		A position in which the valve indicator is pointing up.
C133852	PQ/CMC Container Orientation Terminology	C133915	Valve-down	A position in which the valve indicator is pointing down.	Valve-down		A position in which the valve indicator is pointing down.
C133852	PQ/CMC Container Orientation Terminology	C133999	Inverted	To place upside down.	Inverted		To place upside down.
C133852	PQ/CMC Container Orientation Terminology	C25241	Horizontal	Parallel to or in the plane of the horizon.	Horizontal		Parallel to or in the plane of the horizon.
C133852	PQ/CMC Container Orientation Terminology	C86043	Upright	In a vertical position or posture.	Upright		In a vertical position or posture.
C133853	PQ/CMC Container Type Terminology	C16738	Inhaler	A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth.	INHALER		A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth.
C133853	PQ/CMC Container Type Terminology	C42794	Packaging Tube	A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other.	TUBE		A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other.
C133853	PQ/CMC Container Type Terminology	C43165	Ampule	A container capable of being hermetically sealed, intended to hold sterile materials.	AMPULE		A container capable of being hermetically sealed, intended to hold sterile materials.
C133853	PQ/CMC Container Type Terminology	C43166	Applicator	A pre-filled non-injectable pipette, syringe or tube.	APPLICATOR		A pre-filled non-injectable pipette, syringe or tube.
C133853	PQ/CMC Container Type Terminology	C43167	Bag	A sac or pouch.	BAG		A sac or pouch.
C133853	PQ/CMC Container Type Terminology	C43168	Blister Pack	A package that consists of molded plastic or laminate that has indentations (viewed as 'blisters' when flipped) into which a dosage form, is placed. A covering, usually of laminated material, is then sealed to the molded part. A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between. Suppositories that are strip packed between two layers of foil are also considered a blister pack.	BLISTER PACK		A package that consists of molded plastic or laminate that has indentations (viewed as 'blisters' when flipped) into which a dosage form, is placed. A covering, usually of laminated material, is then sealed to the molded part. A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between. Suppositories that are strip packed between two layers of foil are also considered a blister pack.
C133853	PQ/CMC Container Type Terminology	C43169	Bottle	A vessel with a narrow neck designed to accept a specific closure.	BOTTLE		A vessel with a narrow neck designed to accept a specific closure.
C133853	PQ/CMC Container Type Terminology	C43170	Dispensing Bottle	A bottle that is used by the pharmacist to dispense the prescribed medication. It includes preparations for which a dropper accompanies the bottle.	BOTTLE, DISPENSING		A bottle that is used by the pharmacist to dispense the prescribed medication. It includes preparations for which a dropper accompanies the bottle.
C133853	PQ/CMC Container Type Terminology	C43171	Dropper Bottle	A bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended for the delivery of an exact dose (e.g., calibrated dropper for oral medications).	BOTTLE, DROPPER		A bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended for the delivery of an exact dose (e.g., calibrated dropper for oral medications).
C133853	PQ/CMC Container Type Terminology	C43172	Glass Bottle	A glass vessel with a narrow neck designed to accept a specific closure.	BOTTLE, GLASS		A glass vessel with a narrow neck designed to accept a specific closure.
C133853	PQ/CMC Container Type Terminology	C43173	Plastic Bottle	A plastic vessel with a narrow neck designed to accept a specific closure.	BOTTLE, PLASTIC		A plastic vessel with a narrow neck designed to accept a specific closure.
C133853	PQ/CMC Container Type Terminology	C43174	Pump Bottle	A bottle that is fitted with a pumping mechanism for the administration of drug product.	BOTTLE, PUMP		A bottle that is fitted with a pumping mechanism for the administration of drug product.
C133853	PQ/CMC Container Type Terminology	C43175	Spray Bottle	A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air.	BOTTLE, SPRAY		A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air.
C133853	PQ/CMC Container Type Terminology	C43176	Unit Dose Bottle	A bottle that contains a single whole dose of a non-parenteral drug product.	BOTTLE, UNIT-DOSE		A bottle that contains a single whole dose of a non-parenteral drug product.
C133853	PQ/CMC Container Type Terminology	C43177	Applicator Bottle	A bottle which includes a device for applying its contents.	BOTTLE, WITH APPLICATOR		A bottle which includes a device for applying its contents.
C133853	PQ/CMC Container Type Terminology	C43178	Box	A square or rectangular vessel, usually made of cardboard or plastic.	BOX		A square or rectangular vessel, usually made of cardboard or plastic.
C133853	PQ/CMC Container Type Terminology	C43179	Unit Dose Box	A box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs should be classified under blister pack, since this is the immediate container into which the dosage form is placed.]	BOX, UNIT-DOSE		A box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs should be classified under blister pack, since this is the immediate container into which the dosage form is placed.]
C133853	PQ/CMC Container Type Terminology	C43180	Can	A cylindrical vessel, usually made of metal.	CAN		A cylindrical vessel, usually made of metal.
C133853	PQ/CMC Container Type Terminology	C43181	Canister	A type of can for holding a drug product.	CANISTER		A type of can for holding a drug product.
C133853	PQ/CMC Container Type Terminology	C43182	Carton	A cardboard box or container which is usually considered a secondary packaging component.	CARTON		A cardboard box or container which is usually considered a secondary packaging component.
C133853	PQ/CMC Container Type Terminology	C43183	Cartridge	A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product.	CARTRIDGE		A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product.
C133853	PQ/CMC Container Type Terminology	C43184	Packaging Case	A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed).	CASE		A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed).
C133853	PQ/CMC Container Type Terminology	C43185	Cello Pack	A plastic 'clamshell' [thin plastic pre-formed structure for a device].	CELLO PACK		A plastic 'clamshell' [thin plastic pre-formed structure for a device].
C133853	PQ/CMC Container Type Terminology	C43186	Container	An object that can be used to hold things.	CONTAINER		An object that can be used to hold things.
C133853	PQ/CMC Container Type Terminology	C43187	Cup	A bowl-shaped container.	CUP		A bowl-shaped container.
C133853	PQ/CMC Container Type Terminology	C43188	Unit Dose Cup	A cup intended to hold a single dose of a non-parenteral drug product.	CUP, UNIT-DOSE		A cup intended to hold a single dose of a non-parenteral drug product.
C133853	PQ/CMC Container Type Terminology	C43189	Gas Cylinder	A container designed specifically to hold gases.	CYLINDER		A container designed specifically to hold gases.
C133853	PQ/CMC Container Type Terminology	C43190	Dewar	A container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to prevent the transfer of heat. The inside of the container often has a coating (as silvering) on the inside to reduce heat transfer, and is used especially for storing liquefied gases or for experiments at low temperatures. The size can vary from that of a small thermos bottle up to that which may be mounted upon a large truck (also known as a 'cryogenic truck').	DEWAR		A container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to prevent the transfer of heat. The inside of the container often has a coating (as silvering) on the inside to reduce heat transfer, and is used especially for storing liquefied gases or for experiments at low temperatures. The size can vary from that of a small thermos bottle up to that which may be mounted upon a large truck (also known as a 'cryogenic truck').
C133853	PQ/CMC Container Type Terminology	C43191	Dialpack	A dose pack container designed to assist with patient compliance. The patient turns a dial to the correct day and the correct dose is made available and the container indicates that the dose has been removed.	DIALPACK		A dose pack container designed to assist with patient compliance. The patient turns a dial to the correct day and the correct dose is made available and the container indicates that the dose has been removed.
C133853	PQ/CMC Container Type Terminology	C43192	Dose Pack	A container in which a preselected dose or dose regimen of the medication is placed.	DOSE PACK		A container in which a preselected dose or dose regimen of the medication is placed.
C133853	PQ/CMC Container Type Terminology	C43193	Packaging Drum	A straight-sided cylindrical shipping container with flat ends; one of which can be opened/closed.	DRUM		A straight-sided cylindrical shipping container with flat ends; one of which can be opened/closed.
C133853	PQ/CMC Container Type Terminology	C43194	Inhaler Refill	A container of medication intended to refill an inhaler.	INHALER, REFILL		A container of medication intended to refill an inhaler.
C133853	PQ/CMC Container Type Terminology	C43195	Jar	A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products.	JAR		A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products.
C133853	PQ/CMC Container Type Terminology	C43196	Jug	A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids.	JUG		A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids.
C133853	PQ/CMC Container Type Terminology	C43197	Drug Kit	A packaged set of related pharmaceutical or and/or drug delivery devices used for a particular medical activity or procedure including required documentation for kit components and the entire kit.	KIT		A packaged set of related pharmaceutical or and/or drug delivery devices used for a particular medical activity or procedure including required documentation for kit components and the entire kit.
C133853	PQ/CMC Container Type Terminology	C43198	Combination Package	A package in which two or more drug products that are normally available separately are now available together.	PACKAGE, COMBINATION		A package in which two or more drug products that are normally available separately are now available together.
C133853	PQ/CMC Container Type Terminology	C43199	Packet	An envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed. An example includes glassine powder paper containing aspirin. Other examples include aluminum foil packets into which alcohol swabs and pledgets are placed.	PACKET		An envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed. An example includes glassine powder paper containing aspirin. Other examples include aluminum foil packets into which alcohol swabs and pledgets are placed.
C133853	PQ/CMC Container Type Terminology	C43200	Pouch	A flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive blister packs are inserted, and an overwrap pouch for large volume parenterals).	POUCH		A flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive blister packs are inserted, and an overwrap pouch for large volume parenterals).
C133853	PQ/CMC Container Type Terminology	C43201	Supersack	A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules.	SUPERSACK		A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules.
C133853	PQ/CMC Container Type Terminology	C43202	Syringe	A device for the administration of drug products that consists of a rigid barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.	SYRINGE		A device for the administration of drug products that consists of a rigid barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.
C133853	PQ/CMC Container Type Terminology	C43203	Glass Syringe	A device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.	SYRINGE, GLASS		A device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.
C133853	PQ/CMC Container Type Terminology	C43204	Plastic Syringe	A device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.	SYRINGE, PLASTIC		A device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plunger at one end and a seal or needle at the other end. The needle assembly may be part of the device or separate.
C133853	PQ/CMC Container Type Terminology	C43205	Tabminder	A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens.	TABMINDER		A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens.
C133853	PQ/CMC Container Type Terminology	C43206	Packaging Tank	A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir.	TANK		A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir.
C133853	PQ/CMC Container Type Terminology	C43207	Applicator Tube	A tube which is provided with a device (the applicator) for administering the dosage form. The applicator may be part of the tube closure or be separate.	TUBE, WITH APPLICATOR		A tube which is provided with a device (the applicator) for administering the dosage form. The applicator may be part of the tube closure or be separate.
C133853	PQ/CMC Container Type Terminology	C43208	Dispensing Vial	A vial that is used by the pharmacist to dispense the prescribed medication.	VIAL, DISPENSING		A vial that is used by the pharmacist to dispense the prescribed medication.
C133853	PQ/CMC Container Type Terminology	C43209	Glass Vial	A glass container designed for use with parenteral drug products.	VIAL, GLASS		A glass container designed for use with parenteral drug products.
C133853	PQ/CMC Container Type Terminology	C43210	Multi Dose Vial	A vial intended to contain more than one dose of the drug product.	VIAL, MULTI-DOSE		A vial intended to contain more than one dose of the drug product.
C133853	PQ/CMC Container Type Terminology	C43211	Patent Delivery System Vial	A vial that has a patented delivery system.	VIAL, PATENT DELIVERY SYSTEM		A vial that has a patented delivery system.
C133853	PQ/CMC Container Type Terminology	C43212	Pharmacy Bulk Vial	A container of a sterile preparation whose contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes.	VIAL, PHARMACY BULK PACKAGE		A container of a sterile preparation whose contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes.
C133853	PQ/CMC Container Type Terminology	C43213	Piggyback Vial	A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid.	VIAL, PIGGYBACK		A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid.
C133853	PQ/CMC Container Type Terminology	C43214	Plastic Vial	A plastic container designed for use with parenteral drug products.	VIAL, PLASTIC		A plastic container designed for use with parenteral drug products.
C133853	PQ/CMC Container Type Terminology	C43215	Single Dose Vial	A vial containing a single unit of a parenteral drug product.	VIAL, SINGLE-DOSE		A vial containing a single unit of a parenteral drug product.
C133853	PQ/CMC Container Type Terminology	C43216	Single Use Vial	A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed.	VIAL, SINGLE-USE		A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed.
C133853	PQ/CMC Container Type Terminology	C43226	Parenteral Vial	A container designed for use with parenteral drug products.	VIAL		A container designed for use with parenteral drug products.
C133853	PQ/CMC Container Type Terminology	C43233	Drug Package	The drug product container with any accompanying materials or components. This may include the protective packaging, labeling, administration devices, etc.	PACKAGE		The drug product container with any accompanying materials or components. This may include the protective packaging, labeling, administration devices, etc.
C133853	PQ/CMC Container Type Terminology	C48626	Package Type Not Stated	The package type is not stated or is unavailable.	NOT STATED		The package type is not stated or is unavailable.
C133853	PQ/CMC Container Type Terminology	C53438	Tray	A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its primary or market package. A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit.	TRAY		A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its primary or market package. A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit.
C133853	PQ/CMC Container Type Terminology	C79135	Flexible Intermediate Bulk Container	A receptacle with a body constructed of film, woven plastic, woven fabric, paper or combination thereof, together with any appropriate service equipment and handling devices, and if necessary, an inner coating or liner.	FLEXIBLE INTERMEDIATE BULK CONTAINER		A receptacle with a body constructed of film, woven plastic, woven fabric, paper or combination thereof, together with any appropriate service equipment and handling devices, and if necessary, an inner coating or liner.
C133853	PQ/CMC Container Type Terminology	C79136	Pail	A watertight vessel, often cylindrical, that is usually fitted with a handle, and that may have a lid.	PAIL		A watertight vessel, often cylindrical, that is usually fitted with a handle, and that may have a lid.
C133853	PQ/CMC Container Type Terminology	C82332	Patch	A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body.	PATCH		A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body.
C133853	PQ/CMC Container Type Terminology	C92708	Capsule	A drug packaging type usually in a cylindrical shape with rounded ends. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid drug products.	CAPSULE		A drug packaging type usually in a cylindrical shape with rounded ends. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid drug products.
C133853	PQ/CMC Container Type Terminology	C96141	Petri Dish	A shallow dish with a lid used to culture cells.	Dish, Petri		A shallow dish with a lid used to culture cells.
C133853	PQ/CMC Container Type Terminology	C96142	Microwell Plate	A flat dish type device with multiple wells for testing cellular material.	Plate, Microwell		A flat dish type device with multiple wells for testing cellular material.
C133853	PQ/CMC Container Type Terminology	C96143	Lined Canister	A round container that has an inner layer of a material different from what the canister is composed of.	Canisters, lined		A round container that has an inner layer of a material different from what the canister is composed of.
C133853	PQ/CMC Container Type Terminology	C96144	Flask	A container with a base wider than the narrow neck traditionally used for holding liquids.	Flask		A container with a base wider than the narrow neck traditionally used for holding liquids.
C133856	PQ/CMC Impurity Classification Terminology	C134001	Inorganic Impurity	Any unwanted inorganic compound generated during the manufacturing process of a particular substance or product.	Inorganic		Materials that are not carbon-based and are generated during a manufacturing process that are not part of elemental impurity specification.
C133856	PQ/CMC Impurity Classification Terminology	C176812	Process Related Impurity	Impurities that are derived from the manufacturing process. They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing (e.g., processing reagents or column leachables), or starting materials.	Process Related/Process		Impurities that are derived from the manufacturing process. [Source: SME Defined] Examples: Small molecules -- starting materials, intermediates, antibiotics, or media components, by-products, etc. Large molecules -- They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing  (e.g., processing reagents or resin leachables).
C133856	PQ/CMC Impurity Classification Terminology	C176813	Product Related Impurity	Molecular variants of the desired product (e.g., precursors, certain degradation products arising during manufacture and/or storage) which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety.	Product Related		Molecular variants of the desired product (e.g., precursors, certain degradation products arising during manufacture and/or storage) which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety. [Source: ICH Q6B]
C133856	PQ/CMC Impurity Classification Terminology	C176815	Residual Solvent	Inorganic or organic liquids added during the manufacturing process.	Residual Solvent		Inorganic or organic liquids added during the manufacturing process. [Source: Adapted from ICH Q3A(R2)]
C133856	PQ/CMC Impurity Classification Terminology	C176816	Degradant	An impurity resulting from a chemical change in the drug substance.	Degradation Product		A molecule resulting from a chemical change brought about over time and/or by the action of something (e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system). [Source: SME Defined]
C133856	PQ/CMC Impurity Classification Terminology	C185190	Elemental Impurity	Elements that are found in the environment or that are used or introduced in the manufacture of drug substances or excipients.	Elemental Impurities		Elements that are found in the environment or that are used or introduced in the manufacture of drug substances or excipients. [Source: Elemental Impurities - Information, USP Pharmacopeial Forum, Vol. 36(1)]
C133856	PQ/CMC Impurity Classification Terminology	C185192	Leachable Material	Materials that can migrate from manufacturing systems, container-closure systems and drug-delivery components.	Leachables		Materials that can migrate from manufacturing systems, container-closure systems and drug-delivery components. [Source: Adapted from  ICH Q3E Concept Paper]
C133856	PQ/CMC Impurity Classification Terminology	C92081	Microbial Contamination	The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds).	Microbiological		Microorganism contamination of the cell culture or starting/raw materials that are objectionable due to their detrimental effect on products or potential harm to patients or due to the total number of organisms. [Source: 21CFR211 Preamble]. Examples: bacteria, fungi, mollicutes (mycoplasmas or spiroplasmas), mycobacteria, rickettsia, protozoa, parasites, agents causing TSEs and viruses.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C48793	Equivalent	A person or thing equal to another in value or measure or force or effect or significance etc.; being essentially equal to something.	EQ		
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C61583	Greater Than or Equal To	A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways.	NLT (not less than)		A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C61584	Greater Than	A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status.	MT (more than)		A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C61585	Less Than	A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status.	LT (less than)		A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status.
C133858	PQ/CMC Interpretation Code (numeric) Terminology	C61586	Less Than or Equal To	A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways.	NMT (not more than)		A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways.
C133860	PQ/CMC Quality Benchmark Terminology	C134006	United States Pharmacopeia-National Formulary	An official publication managed and maintained by the US Pharamacopeial Convention, that gives the composition, description, method of preparation, and dosage for drugs.	USP-NF		An official publication managed and maintained by the US Pharamacopeial Convention, that gives the composition, description, method of preparation, and dosage for drugs.
C133860	PQ/CMC Quality Benchmark Terminology	C134007	European Pharmacopeia	A European reference publication from that is a legal and scientific benchmark for pharmacopoeial standards.	EP		A European reference publication from that is a legal and scientific benchmark for pharmacopoeial standards.
C133860	PQ/CMC Quality Benchmark Terminology	C134008	Japanese Pharmacopeia	A reference publication considered the official pharmacopoeia of Japan that is published under the authority of the Ministry of Health, Labour and Welfare.	JP		A reference publication considered the official pharmacopoeia of Japan that is published under the authority of the Ministry of Health, Labour and Welfare.
C133860	PQ/CMC Quality Benchmark Terminology	C134009	Company Standard	A trademarked, copyrighted standard belonging to an organization.	Company Standard		A trademarked, copyrighted standard belonging to an organization.
C133860	PQ/CMC Quality Benchmark Terminology	C176793	British Pharmacopeia	A British reference publication from that is a legal and scientific benchmark for pharmacopoeial standards.	BP		A British reference publication from that is a legal and scientific benchmark for pharmacopoeial standards.
C133862	PQ/CMC Source Type Terminology	C14182	Animal	A living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral.	Animal		A living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral.
C133862	PQ/CMC Source Type Terminology	C14225	Human	The bipedal primate mammal, Homo sapiens; belonging to man or mankind; pertaining to man or to the race of man; use of man as experimental subject or unit of analysis in research.	Human		The bipedal primate mammal, Homo sapiens; belonging to man or mankind; pertaining to man or to the race of man; use of man as experimental subject or unit of analysis in research.
C133862	PQ/CMC Source Type Terminology	C14227	Insect	A taxonomic class of arthropods that includes praying mantises, dragonflies, grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and beetles.	Insect		A taxonomic class of arthropods that includes praying mantises, dragonflies, grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and beetles.
C133862	PQ/CMC Source Type Terminology	C14258	Plant	Any living organism that typically synthesizes its food from inorganic substances, possesses cellulose cell walls, responds slowly and often permanently to a stimulus, lacks specialized sense organs and nervous system, and has no powers of locomotion. (EPA Terminology Reference System)	Plant		Any living organism that typically synthesizes its food from inorganic substances, possesses cellulose cell walls, responds slowly and often permanently to a stimulus, lacks specialized sense organs and nervous system, and has no powers of locomotion. (EPA Terminology Reference System)
C133862	PQ/CMC Source Type Terminology	C14329	Microorganism	A microscopic organism. The term microorganism may refer to a prokaryote or eukaryote, and may be a unicellular or multicellular organism. All taxonomic kingdoms contain microorganisms.	Microbial		A microscopic organism. The term microorganism may refer to a prokaryote or eukaryote, and may be a unicellular or multicellular organism. All taxonomic kingdoms contain microorganisms.
C133862	PQ/CMC Source Type Terminology	C18634	Animal Sources	Indicates that a product is derived from an animal.	Animal-derived indirectly		Indicates that a product is derived from an animal.
C133862	PQ/CMC Source Type Terminology	C48807	Chemical	A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties.	Chemical		A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties.
C133863	PQ/CMC Specification Status Terminology	C134010	Tentative Approval	Provisional approval of a specification.	Tentatively Approved		Provisional approval of a specification.
C133863	PQ/CMC Specification Status Terminology	C134011	Not Approved	A specification that has not yet been approved.	Not Approved		A specification that has not yet been approved.
C133863	PQ/CMC Specification Status Terminology	C134012	Reported in a CBE or AR	The specification may be used without prior approval, and was submitted in a changes being effected (CBE) supplement or an annual report (AR).	Reported in a CBE or AR		The specification may be used without prior approval, and was submitted in a changes being effected (CBE) supplement or an annual report (AR).
C133863	PQ/CMC Specification Status Terminology	C25425	Approval	Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval.	Approved		Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval.
C133863	PQ/CMC Specification Status Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C133864	PQ/CMC Specification Type Terminology	C133931	Raw Materials/Excipients/Intermediates/Reagents Specification	The specification which is applied to the raw materials, excipients, intermediates or reagents.	Raw Materials/Excipients/Intermediates/Reagents		The specification which is applied to the raw materials, excipients, intermediates or reagents.
C133864	PQ/CMC Specification Type Terminology	C134021	Drug Product Specification	The specification which is applied to the drug product.	Drug Product		The specification which is applied to the drug product.
C133864	PQ/CMC Specification Type Terminology	C134022	Drug Substance Specification	The specification which is applied to the drug substance.	Drug Substance		The specification which is applied to the drug substance.
C133865	PQ/CMC Storage Conditions Terminology	C133935	Temperature 5 (+/-) 3 Degrees C	Storage at 5 degrees C (+/-) 3 degrees C.	5 +/- 3 degrees C		Storage at 5 degrees C (+/-) 3 degrees C.
C133865	PQ/CMC Storage Conditions Terminology	C133936	Temperature -20 (+/-) 5 Degrees C	Storage at -20 degrees C (+/-) 5 degrees C.	-20 +/- 5 degrees C		Storage at -20 degrees C (+/-) 5 degrees C.
C133865	PQ/CMC Storage Conditions Terminology	C133940	Temperature 40 (+/-) 2 Degrees C and Relative Humidity Not More Than 25%	Storage at 40 degrees C (+/-) 2 degrees C and Relative Humidity not more than 25%.	40 degrees C +/- 2 degrees C/not more than (NMT) 25%RH		
C133865	PQ/CMC Storage Conditions Terminology	C134014	Temperature 25 (+/-) 2 Degrees C and Relative Humidity 60% (+/-) 5%	Storage at 25 degrees C (+/-) 2 degrees C and 60% Relative Humidity (+/-) 5% Relative Humidity.	25 +/- 2 degrees C/60% +/- 5%RH		Storage at 25 degrees C (+/-) 2 degrees C and 60% Relative Humidity (+/-) 5% Relative Humidity.
C133865	PQ/CMC Storage Conditions Terminology	C134015	Temperature 30 (+/-) 2 Degrees C and Relative Humidity 65% (+/-) 5%	Storage at 30 degrees C (+/-) 2 degrees C and 65% Relative Humidity (+/-) 5% Relative Humidity.	30 +/- 2 degrees C/65% +/- 5%RH		Storage at 30 degrees C (+/-) 2 degrees C and 65% Relative Humidity (+/-) 5% Relative Humidity.
C133865	PQ/CMC Storage Conditions Terminology	C134016	Temperature 40 (+/-) 2 Degrees C and Relative Humidity 75% (+/-) 5%	Storage at 40 degrees C (+/-) 2 degrees C and 75% Relative Humidity (+/-) 5% Relative Humidity.	40 +/- 2 degrees C/75% +/- 5%RH		Storage at 40 degrees C (+/-) 2 degrees C and 75% Relative Humidity (+/-) 5% Relative Humidity.
C133865	PQ/CMC Storage Conditions Terminology	C134017	Temperature 30 (+/-) 2 Degrees C and Relative Humidity 75% (+/-) 5%	Storage at 30 degrees C (+/-) 2 degrees C and 75% Relative Humidity (+/-) 5% Relative Humidity.	30 +/- 2 degrees C/75% +/- 5%RH		Storage at 30 degrees C (+/-) 2 degrees C and 75% Relative Humidity (+/-) 5% Relative Humidity.
C133865	PQ/CMC Storage Conditions Terminology	C134018	Temperature 25 (+/-) 2 Degrees C and Relative Humidity 40% (+/-) 5%	Storage at 25 degrees C (+/-) 2 degrees C and 40% Relative Humidity (+/-) 5% Relative Humidity.	25 +/- 2 degrees C/40% +/- 5%RH		
C133865	PQ/CMC Storage Conditions Terminology	C134019	Temperature 30 (+/-) 2 Degrees C and Relative Humidity 35% (+/-) 5%	Storage at 30 degrees C (+/-) 2 degrees C and 35% Relative Humidity (+/-) 5% Relative Humidity.	30 degrees C +/- 2 degrees C/35%RH +/- 5%RH		
C133865	PQ/CMC Storage Conditions Terminology	C96148	Proprietary Storage Condition	Storage conditions according to protocols set by a business or company.	Proprietary		Storage conditions according to protocols set by a business or company.
C133866	PQ/CMC Study Type Terminology	C134026	Standard Environmental Condition	A single set of environmental conditions.	Standard		A single set of environmental conditions.  Example:  25 degree C, 60% RH, etc.
C133866	PQ/CMC Study Type Terminology	C134027	Cycled-Simple Environmental Condition	A set of two alternating environmental conditions.	Cycled-Simple		A set of two alternating environmental conditions. Example: freeze-thaw cycled study.
C133866	PQ/CMC Study Type Terminology	C134028	Complex Environmental Condition	Multiple phases with different sets of environmental conditions.	Complex		Multiple phases with different sets of environmental conditions. Examples: typically for inhalers, nebulizers, transportation studies etc.
C133866	PQ/CMC Study Type Terminology	C96087	Photostability Drug Study	A study conducted to determine the extent of effect that exposure to light has on a pharmaceutical product.	Photostability		Studies that evaluate the light sensitivity and stability of drugs.
C133867	PQ/CMC Test Method Origin Terminology	C96102	Compendial Method	Standardized methods and specification testing for generic pharmaceutical raw materials and finished products.	Compendial		Standardized methods and specification testing for generic pharmaceutical raw materials and finished products.
C133867	PQ/CMC Test Method Origin Terminology	C96103	Proprietary Method	An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing.	Proprietary		An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing.
C133867	PQ/CMC Test Method Origin Terminology	C96164	Code of Federal Regulations Method	A method described in the Code of Federal Regulations.	CFR		A method described in the Code of Federal Regulations.
C133868	PQ/CMC Test Usage Terminology	C134029	Release Determination	For determination of acceptability for use of a material, drug or a drug substance.	Release		For determination of acceptability for use of a material, drug or a drug substance.
C133868	PQ/CMC Test Usage Terminology	C134030	Stability Determination	For determination of maintained performance parameters on storage over time, of a material, drug or a drug substance.	Stability		For determination of maintained performance parameters on storage over time, of a material, drug or a drug substance.
C168622	PQ/CMC Strength Operator Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C168622	PQ/CMC Strength Operator Terminology	C48793	Equivalent	A person or thing equal to another in value or measure or force or effect or significance etc.; being essentially equal to something.	EQ		
C168622	PQ/CMC Strength Operator Terminology	C61583	Greater Than or Equal To	A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways.	NLT (not less than)		A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest exceeds the other object in one of these ways.
C168622	PQ/CMC Strength Operator Terminology	C61584	Greater Than	A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status.	MT (more than)		A statement about the relative size or order of two objects specifying that an object of interest exceeds another object in quantity or measure or value or status.
C168622	PQ/CMC Strength Operator Terminology	C61585	Less Than	A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status.	LT (less than)		A statement about the relative size or order of two objects specifying that an object of interest is smaller than another object in quantity or measure or value or status.
C168622	PQ/CMC Strength Operator Terminology	C61586	Less Than or Equal To	A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways.	NMT (not more than)		A statement about the relative size or order of two objects specifying that either both objects are the same in quantity or measure or value or status or that the object of interest is smaller than the other object in one of these ways.
C168624	PQ/CMC Organization-Site Identifier Type Terminology	C134003	Data Universal Numbering System	A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location.	DUNS		A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location.
C168624	PQ/CMC Organization-Site Identifier Type Terminology	C134004	Facility FDA Establishment Identifier	A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments.	FEI		A unique identifier assigned by the Food and Drug Administration (FDA) to track inspections of a regulated establishment or facility. They are also used to track generic drug user fee acts (GDUFA) facility fee payments.
C168624	PQ/CMC Organization-Site Identifier Type Terminology	C134005	Central File Number	A seven digit number assigned by the Food and Drug Administration (FDA).	CFN		A seven digit number assigned by the Food and Drug Administration (FDA).
C168624	PQ/CMC Organization-Site Identifier Type Terminology	C17998	Unknown	Not known, observed, recorded; or reported as unknown by the data contributor.	Unknown		Not known, not observed, not recorded, or refused.
C168627	PQ/CMC Strength Type Terminology	C168628	Drug Component Mass	The mass of the active and inactive substances in a drug component.	Mass		The amount of active and/or inactive substance of a drug component.
C168627	PQ/CMC Strength Type Terminology	C45420	Biochemical Activity	A measurable amount of a specific function or role performed by a entity in a biophysical process, biochemical reaction, or biochemical process.	Activity		A measure of a property related to therapeutic or biological effect. Example, enzyme activity.
C176675	PQ/CMC Drug Product Component Function Category Terminology	C2140	Adjuvant	An agent that enhances the activity or therapeutic effect of another pharmacologic substance without having much, if any, therapeutic impact by itself.	Adjuvant		An ingredient which augments or promotes the pharmacological effect of the active ingredient(s) without itself being considered active (note that adjuvants are used only with vaccines).
C176675	PQ/CMC Drug Product Component Function Category Terminology	C42637	Pharmaceutical Excipient	Any intentionally added component of a finished pharmaceutical product other than the claimed therapeutic or diagnostic ingredient(s). The excipients are added to facilitate administration or manufacture, improve product delivery, promote the consistent release and bioavailability of the drug, enhance stability, assist in product identification, or enhance other product characteristics. Pharmaceutical excipients do not affect therapeutic effects of the preparation or suitable tests or assays. The term does not apply to macromolecular compounds like albumin, or compounds like amino acids and sugars that are used in biological products, nor does it apply to process or product-related impurities (e.g. degradation products, residual solvents), or extraneous contaminants.	Inactive Ingredient		An ingredient that is added for a purpose other than the intended pharmacological action.
C176675	PQ/CMC Drug Product Component Function Category Terminology	C82533	Active Ingredient	The pharmaceutically active components of a preparation.	Active Ingredient		An ingredient that has the intended pharmacological action.
C176676	PQ/CMC Excipient Function Terminology	C176632	Emollient Excipient	A substance within a topical formulation that is used to promote softening and retention of moisture when applied to skin.	Emollient		Agent added to topical formulations to promote softening of the skin. Used in topical preparations to impart lubrication, spreading ease, texture, and softening of the skin and to counter the potentially drying/irritating effect of surfactants on the skin (e.g. skin protectant). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176633	Emulsion Stabilizing Excipient	A substance within a formulation that is used to stabilize a mixture and prevent against phase separation.	Emulsion stabilizing agent		Agent added to improve stability against phase separation. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176634	Foam Stabilizing Excipient	A substance within a foam formulation that is used to maintain or improve its stability.	Foam stabilizing agent		Agent added to improve physical stability of foam (e.g. foaming agent). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176635	Organoleptic Excipient	A substance within a formulation that modifies its color, flavor or taste.	Organoleptic agent		An agent added to modify color, flavor, taste (e.g. flavoring agent; flavor enhancer; sweetening agent; taste-masking agent).
C176676	PQ/CMC Excipient Function Terminology	C176636	Stabilizing Excipient	A substance within a formulation that is used to preserve its integrity and prevent its degradation.	Stabilizer		Agent added to preserve product integrity and prevent degradation (e.g. stabilizing agent; colloid stabilizing agent).
C176676	PQ/CMC Excipient Function Terminology	C176637	Absorption Modifying Excipient	A substance within a formulation that is used to enhance the bioavailability of the agent by modifying its absorption properties.	Absorption modifier		An excipient included in formulations to improve the absorption of a pharmacologically active drug (e.g. permeation enhancer; transmucosal absorption enhancer; intestinal permeation enhancer; delivery agent; penetration enhancer; transdermal delivery agent).
C176676	PQ/CMC Excipient Function Terminology	C176638	Effervescent Excipient	A substance within a powder or tablet formulation that is used to produce carbon dioxide when placed in an aqueous solution.	Effervescent agent		Effervescent excipients are used in powders and tablets. They are commonly used with acidic agents to cause a reaction that produces carbon dioxide. The carbon dioxide leads to a fizzing of the effervescent powder. (Adapted from American Pharmaceutical Review)
C176676	PQ/CMC Excipient Function Terminology	C176639	Reducing Excipient	A substance within a formulation that reduces its oxidation state in order to optimize the properties of the active ingredient(s).	Reducing agent		Reduces oxidation state of product component to produce desired active component/ingredient.
C176676	PQ/CMC Excipient Function Terminology	C176640	Solubilizing Excipient	A substance within a formulation that enhances the solubility of another substance.	Solubilizing agent		Enhance solubility of the active substance. (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.)
C176676	PQ/CMC Excipient Function Terminology	C176641	Tonicity Excipient	A substance within a liquid formulation that alters its osmotic potential.	Tonicity agent		Agent added to alter osmotic potential of liquid formulations. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176642	Adsorbent	A substance used to absorb fluid-like substances on their surface and to increase the dissolution rates of relatively water-insoluble drugs in order to make them easier to incorporate into solid dosage forms.	Adsorbent		Agent used to bind another component from within a formulation, acting as a carrier, reservoir or sequestrant (e.g. water-absorbing agent). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176643	Air Displacement Agent	A gaseous substance used to replace air in product packaging.	Air displacement		Agent used to replace air in a product or pack with a gas phase of known composition during manufacturing. Example is widely used In reactors/mixing tanks with liquid products (e.g. air overlay; gas blanket). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176644	Bulking Excipient	A substance within a formulation that is used to solidify its intended shape.	Bulking agent		To provide a pharmaceutically elegant freeze-dried cake. (Adapted from USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176645	Carrier Excipient	A substance within a formulation that is used to interact with and enhance the properties of active ingredients.	Carrier		Agents designed to interact with, and enhance the properties, of active pharmaceutical ingredients (APIs). Carrier excipients promote various ingredient qualities and have become a valuable asset for drug formulators. Used to help deposit the active ingredient in the lung and may have a secondary role in diluting the active to ensure that dosages can be properly metered (e.g. solid carrier; sorbent; carbon dioxide). (Adapted from American Pharmaceutical Review)
C176676	PQ/CMC Excipient Function Terminology	C176646	Complexing Excipient	A substance within a formulation that is used to combine with other components in order to maintain or improve solubility or stability.	Complexing agent		Agent added to combine with another component, commonly to maintain or improve solubility or chemical stability. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176647	Denaturant	A substance added to a product containing alcohol in order to render it unfit for consumption.	Denaturant		Agent added to make unfit to drink an ethanol containing product.
C176676	PQ/CMC Excipient Function Terminology	C176648	Film Coating Excipient	An agent used to produce a film covering the outer surface of a solid formulation.	Film coating agent		Agent used to produce a cosmetic or functional layer on the outer surface of a dosage form. Agents used to mask unpleasant tastes or odors, improve ingestion and appearance, protect active ingredients from the environment, and modify the release of the active ingredient or product subcomponent (e.g. coating agent; film-forming agent; film former; granulating agent; granulating fluid; film-coating dispersion medium). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176649	Free Radical Scavenging Excipient	A substance within a formulation that interacts with free radicals to prevent their degrading activity on other components.	Free radical scavenger		Used to preferentially interact with oxidative or reductive free radicals that otherwise would result in degradation of formulation components.  (Adapted from USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176650	Gelling Excipient	A substance within a semisolid formulation that produces a gel-like texture.	Gelling agent		Agent added to produce a gel texture in a product. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176651	Humectant Excipient	A substance within a topical formulation that is used to increase the solubility of the active ingredient, improve its penetration into skin and prolong its activity time.	Humectant		Humectants can be used in topical dosage forms to increase the solubility of a chemical compound's active ingredients, increasing the active ingredients' ability to penetrate skin, or its activity time. Examples: propylene glycol, sorbitol solution, ammonium alginate, cyclomethicone, glycerin, polydextrose, sodium hyaluronate, and sodium lactate.
C176676	PQ/CMC Excipient Function Terminology	C176652	Lyophilization Excipient	A substance within a formulation that aids in freeze-drying of the product.	Lyophilization aid		Agent added to produce suitable physical properties in a freeze-dried product. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176653	Matrix Forming Excipient	A polymer within a sustained-release formulation that maintains matrix rigidity over a prolonged period.	Matrix-forming agent		Polymers added to sustained release formulations to control and maintain the rigidity of the matrix over a prolonged period (e.g. sustained-release agent; matrix for sustained release; rate-controlling polymer for sustained release). (Adapted from \The Role of Oral Controlled Release Matrix Tablets in Drug Delivery Systems\, Ali Nokhodchi1, Shaista Raja1, Pryia Patel1, Kofi Asare-Addo BioImpacts, 2012, 2(4), 175-187)
C176676	PQ/CMC Excipient Function Terminology	C176654	Microencapsulating Excipient	A substance within a formulation that promotes the formation of tiny spherical particles.	Microencapsulating agent		Agent used to form microcapsules with desirable physical properties. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176655	Ointment Base	A non-aqueous, semisolid vehicle used as a foundation for ointment formulations.	Ointment base		A nonaqueous vehicle for topical products. The major component of an ointment and controls its physical properties. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176656	Opacifying Excipient	A substance within a formulation that reduces light transmission.	Opacifier		Agent added to reduce light transmission in a product (e.g. opacifying agent). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176657	Osmotic Excipient	A substance within a formulation that allows for a controlled rate of release by creating an osmotic pressure differential between the drug and the external environment.	Osmotic agent		Material used to provide osmotic pressure differential in osmotic pump based drug product delivery systems.
C176676	PQ/CMC Excipient Function Terminology	C176658	pH Modifying Excipient	A substance within a formulation that alters its acidity or basicity.	pH modifier		Substance added to alter the acidity or basicity (e.g. acidity regulator; acidifying agent/alkalizing agent; acid; base).
C176676	PQ/CMC Excipient Function Terminology	C176659	Polishing Excipient	A substance within a formulation that provides a sheen to coated tablets.	Polishing agent		Agent used to impart an attractive sheen to coated tablets (e.g. tablet polishing agent).
C176676	PQ/CMC Excipient Function Terminology	C176660	Ophthalmic Polymer	A polymer within ophthalmic formulations used to promote the retention of its active ingredients after application to the eye.	Polymers for ophthalmic use		Used in ophthalmic preparations to enhance the retention of active ingredients by reducing the amount of product that is lost from the eye when the patient blinks. In addition, polymers also can be components of artificial tears. (Adapted from USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176661	Propellant	A substance used to create pressure within a container to expel the product within.	Propellant		Developing pressure in container which expels the product. Used in pharmaceuticals (nasal sprays and respiratory and topical formulations), cosmetics, and foods to provide force to expel contents from a container (e.g. aerosol propellant). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176662	Release Modifying Excipient	A substance within a formulation that controls how the product is released.	Release modifying agent		Substances added to the formulation to alter the release profile of the active substance (e.g. release modifier; release agent; modifying agent; extended release agent; controlled release agent; latex particle coating agent).
C176676	PQ/CMC Excipient Function Terminology	C176663	Suppository Base	A solid or semisolid, hydrophilic or hydrophobic vehicle used as a foundation for suppository formulations.	Suppository base		Agent used as the carrier for other ingredients in suppository formulations. Used in the manufacture of suppositories (for rectal administration) and pessaries (for vaginal administration). They can be hydrophobic or hydrophilic, (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C176664	Transdermal Delivery Excipient	A substance within a topical formulation that affects its penetration of the skin.	Transdermal delivery component		A component of a transdermal system otherwise not covered by other terms.
C176676	PQ/CMC Excipient Function Terminology	C176665	Transfer Ligand Excipient	A substance within a radiopharmaceutical formulation that allows for the transfer of a weaker chelating ligand to the principal chelating ligand or complexing moiety.	Transfer ligand		Used in the preparation radiopharmaceuticals to transfer a relatively weak chelating ligand to the principal chelating ligand or complexing moiety. (USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C176666	Viscosity Modifying Excipient	A substance within a formulation that alters its thickness or texture to optimize its administration.	Viscosity modifier		Viscosity modifiers are designed to change the thickness or texture of pharmaceutical ingredients. Viscosity modifiers can include such products as thickeners, texturizers, gelation agents and stiffening agents (e.g. stiffening agent; thickener; thickening agent; viscosity-increasing agent; firming agent). (Adapted from American Pharmaceutical Review)
C176676	PQ/CMC Excipient Function Terminology	C176667	Water Repelling Excipient	A substance within a formulation that enhances its hydrophobicity.	Water-repelling agent		An agent used to enhance hydrophobic properties.
C176676	PQ/CMC Excipient Function Terminology	C176668	Wetting Excipient	A substance within a liquid formulation that reduces its surface tension and allows for more uniform spreading and penetration of surfaces during application.	Wetting agent		An agent added to a liquid to reduce its surface tension and make it more effective in spreading over and penetrating surfaces.
C176676	PQ/CMC Excipient Function Terminology	C275	Antioxidant	A group of organic or inorganic substances capable of preventing the genotoxic and carcinogenic effects of free-radical compounds. Antioxidants bind to and neutralize ('scavenge') free radicals, thereby transforming them into non-toxic compounds and blocking their genotoxic and carcinogenic effects. This class of agents includes the vitamins C and E, the carotenoids, and selenium. Organic antioxidants are found in high concentrations in fruits, seeds and vegetables.	Antioxidant		Agent used to stabilize a system against oxidative degradation. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C360	Chelating Agent	An inorganic or organic molecule which binds metal ions. Metal chelators are frequently polydentate, indicating that they form multiple bonds with the metal ion, resulting in more stable coordination complexes.	Chelating agent		Used to sequester ions from solution and to form stable complexes (e.g. sequestering agent). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C42647	Binder Excipient	An inactive ingredient of the solid pharmaceutical dosage form added to cement the active and inert components of tablets together to maintain cohesive and discrete portions. These are especially important in the production of time-release products. Binders provide the matrix from which the drug is gradually secreted. Binding agents which have adhesive properties are important excipients, especially for lozenges and tablets. The choice of the particular binder or thickening agent is dependent upon the desired properties of adhesive strength and thickness. Thus, one would be a better agent for a lozenge when slow dissolution in the mouth is desirable whereas another would provide more rapid disintegration for other purposes. The commonly used binder excipients in U.S.-manufactured drug products are microcrystalline cellulose and starch.	Binder		Impart cohesive qualities to powdered material (e.g. binding agent or wet binder). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C42648	Disintegrant Excipient	Disintegrant excipient is a therapeutically inactive ingredient of a solid pharmaceutical dosage form that helps the form to dissolve within the gastrointestinal tract to ensure full release of the pharmaceutically active material. Disintegration rate of the tablet may be the rate limiting step for the absorption of the drug. Currently, disintegrants have been developed to the point that disintegration is not usually the rate limiting step. The US Pharmacopeia sets a time limit for disintegration. Microcrystalline cellulose and starch are examples of disintegrants.	Disintegrant		An agent used to facilitate breakup or disintegration after administration. Functional components that are added to formulations to promote rapid disintegration into smaller units and to allow a drug substance to dissolve more rapidly. (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C42650	Filler Excipient	A therapeutically inactive ingredient of a solid pharmaceutical dosage form that is used to increase the volume of the material to accommodate easier processing of the drug and to make it a suitable size for patient consumption Typical fillers include calcium phosphate (also an added source of both minerals), lactose, powder, sucrose powder.	Filler		Make up the bulk of solid unit dosage forms when drug itself is inadequate to produce the bulk. Components that are incorporated into tablet or capsule dosage forms to increase dosage form volume or weight (e.g. diluent; dry powder inhalation; bulking agent). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, Maharashtra, India.  USP <1059>)
C176676	PQ/CMC Excipient Function Terminology	C42653	Lubricant Excipient	Lubricant excipient is a therapeutically inactive substance used to facilitate the release of stamped solid pharmaceutical dosage forms, e.g. tablets, out of the die once pressed, improving the efficiency of manufacturing. Magnesium stearate is an example.	Lubricant		Agent added to reduce friction effects during processing or use. Used to reduce the frictional forces between particles and between particles and metal-contact surfaces of manufacturing equipment (e.g. tablet ejection; antiadherent; antistat; glidant). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C42654	Glidant Excipient	An inactive ingredient of the pharmaceutical dosage form that is added to promote powder flow during the manufacture of pills.	Anticaking agent		Agent added to improve powder flow. Used to promote powder flow and to reduce the caking or clumping that can occur when powders are stored in bulk. In addition, glidants and anticaking agents reduce the incidence of bridging during the emptying of powder hoppers and during powder processing. (e.g. glidant). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C42656	Color Excipient	Therapeutically inactive dye or coloring agent that is a component of pharmaceutical product. There are more than 100 excipient colors approved by the FDA for pharmaceutical use.	Coloring agent		Agent to impart hue to a component (e.g. color retention agent, dye).
C176676	PQ/CMC Excipient Function Terminology	C42657	Printing Ink Excipient	The constituents of printing inks used to mark an ingested pharmaceutical dosage form.	Ink		A colored fluid or paste used for writing, drawing, typically used to identify a product and its strength.
C176676	PQ/CMC Excipient Function Terminology	C42659	Preservative Excipient	Chemicals that are added to drug products to prolong shelf life and maintain sterility. Protection of formulations, especially aqueous solutions, against microbial growth requires use of either antibacterial or antifungal preservatives. Generally, such agents are active against either bacteria or fungi but a few are active against both. The antimicrobials include but not limited to chlorobutanol, benzyl alcohol, sodium benzoate, sorbic acid, and phenol. The antioxidizing agents include butylated hydroxytoluene, hydroxyanisole, propyl gallate, and sulfites. The necessary addition of preservatives for both safety and economy sometimes has been associated with significant adverse effects in certain patient populations.	Preservative		An agent added to extend the shelf-life of a formulation (e.g. antibacterial agent; antifungal agent preservative; fungicides; antimicrobial preservative; antiviral agent preservative; viricides; sterilizing agent; glazing agent).
C176676	PQ/CMC Excipient Function Terminology	C42660	Suspending Excipient	Therapeutically inactive ingredient of pharmaceutical dosage form used to prevent aggregation of the active drug in liquid form, allowing uniform concentrations to be maintained for accurate dosing.	Suspending agent		A non-surface active polymer or a surface-active substance added to a suspension, to improve the separation of particles and to prevent settling or clumping (e.g. dispersing agent).
C176676	PQ/CMC Excipient Function Terminology	C42662	Dispersing Excipient	An inactive ingredient of the pharmaceutical dosage form that is added to disperse a solid, poorly-water-soluble pharmacological agent in a liquid and to prevent clumping of the drug.	Dispersing agent		Agent added to prevent aggregation in liquid formulations. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C42739	Surfactant Excipient	A surface active agent (surfactant), in dilute solution, moves to the interface of a two-phase system and reduces the surface free energy. This permits the two phases to mix more completely. Surface active agents are usually soluble both in aqueous and non-aqueous solvents. They are exemplified by soap-type molecules (long chain fatty acid salts) such as sodium lauryl sulfate.	Surfactant		Substances used to enhance stability by reducing surface tension (e.g. anionic surfactant; cationic surfactant; nonionic surfactant).
C176676	PQ/CMC Excipient Function Terminology	C45790	Solvent	A liquid that dissolves or that is capable of dissolving; the component of a solution that is present in greater amount.	Solvent		The liquid in which a solute is dissolved to form a solution.
C176676	PQ/CMC Excipient Function Terminology	C53306	Cryoprotective Agent	A substance that is used to protect from the effects of freezing, largely by preventing large ice crystals from forming.	Cryoprotectant		Agent added to prevent cell damage during freeze-drying. (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C55826	Plasticizer	A substance added to plastics or other materials to make or keep them soft or pliable.	Plasticizer		Agent added to promote flexibility of films or coatings (e.g. plasticizing agent). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C70815	Buffer	An ionic compound that resists changes in its pH.	Buffering agent		Agent used to stabilize pH within a defined range.  (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C73477	Emulsifying Excipient	A chemical substance that functions to stabilize an emulsion.	Emulsifying Excipient		Agent added to promote mixing of immiscible phases (e.g. fluorocarbon emulsifying agent; emulsifier; emulsifying salt). (Adapted from Medicinescomplete)
C176676	PQ/CMC Excipient Function Terminology	C89528	Adhesive Device	Any substance that affixes 2 or more parts or tissues together.	Adhesive		Substance capable of bonding together two surfaces (e.g. bioadhesive material).
C176676	PQ/CMC Excipient Function Terminology	C927	Drug Vehicle	A substance used as a medium for administration of a pharmaceutical.	Vehicle		A substance that facilitates the use of a drug, or other material mixed with it, not covered by other terms (e.g. oleaginous vehicle).
C176677	PQ/CMC Units of Measure Terminology	C105491	Kilodalton	A unit of atomic mass equal to one thousand daltons.	ku	kiloDalton	
C176677	PQ/CMC Units of Measure Terminology	C122629	Actuation Dosing Unit	A dosing unit equal to the amount of active ingredient(s) contained in an actuation.	{actuation}	actuation	
C176677	PQ/CMC Units of Measure Terminology	C139134	Linear Foot Pound	A unit of energy that equals the work required to move one pound a distance of one foot in the direction of the applied force.	[lbf_av]	pound foot	
C176677	PQ/CMC Units of Measure Terminology	C154859	Microsiemens	A unit of electrical conductance, admittance, and susceptance equal to one millionth of a Siemens (10E-6 Siemens).	umho	micromhos	
C176677	PQ/CMC Units of Measure Terminology	C171022	Particle Total Count	A quantitative value for the total particles in a sample.	{tot}	particles	
C176677	PQ/CMC Units of Measure Terminology	C176690	Millisiemens	One-thousandth of a siemens, a decimal fraction of the SI unit of electrical conductance and admittance siemens and is equal to 10^-3 siemens.	ms	millisiemens	
C176677	PQ/CMC Units of Measure Terminology	C205478	Microgram per Actuation	The amount of micrograms of a substance contained in a single actuation of a device.	ug/{actuation}	micrograms per actuation	
C176677	PQ/CMC Units of Measure Terminology	C207698	Nephelometric Turbidity Unit	The reference unit used to measure the turbidity of a fluid or the presence of suspended particles in water.	[NTU]	Nephelometric Turbidity Unit	
C176677	PQ/CMC Units of Measure Terminology	C207699	Formazin Nephelometric Unit	A unit of measure of turbidity in which the FNU is measured with an infrared light source in accordance with the ISO 7027 method.	[FNU]	Formazin Nephelometric Unit	
C176677	PQ/CMC Units of Measure Terminology	C207700	Jackson Turbidity Unit	An obsolete unit measuring the clarity of water in which one views the flame of a candle through a vertical tube of the water to be measured.	[JTU]	Jackson Turbidity Unit	
C176677	PQ/CMC Units of Measure Terminology	C25301	Day	The time for Earth to make a complete rotation on its axis; ordinarily divided into twenty-four hours, equal to 86 400 seconds. This also refers to a specific day.	d	day	
C176677	PQ/CMC Units of Measure Terminology	C25529	Hour	A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day.	h	hour	
C176677	PQ/CMC Units of Measure Terminology	C28251	Millimeter	A metric unit of length equal to one thousandth of a meter (10E-3 meter) or approximately 0.03937 inch.	mm	millimeter	
C176677	PQ/CMC Units of Measure Terminology	C28252	Kilogram	A basic SI unit of mass. It is defined as the mass of an international prototype in the form of a platinum-iridium cylinder kept at Sevres in France. A kilogram is equal to 1,000 grams and 2.204 622 6 pounds.	kg	kilogram	
C176677	PQ/CMC Units of Measure Terminology	C28253	Milligram	A metric unit of mass equal to one thousandth of a gram or 1000 micrograms. One milligram equals approximately 0.015 432 grain or 35.274 x 10E-6 ounce.	mg	milligram	
C176677	PQ/CMC Units of Measure Terminology	C28254	Milliliter	A unit of volume equal to one millionth (10E-6) of a cubic meter, one thousandth of a liter, one cubic centimeter, or 0.061023 7 cubic inch. A cubic centimeter is the CGS unit of volume.	mL	cm3 || cubic centimeter || milliliter	
C176677	PQ/CMC Units of Measure Terminology	C29844	Week	Any period of seven consecutive days.	wk	week	
C176677	PQ/CMC Units of Measure Terminology	C29846	Month	One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks.	mo	month	
C176677	PQ/CMC Units of Measure Terminology	C29848	Year	A period of time that it takes for Earth to make a complete revolution around the sun, approximately 365 days; a specific one year period.	a	year	
C176677	PQ/CMC Units of Measure Terminology	C41127	Unified Atomic Mass Unit	The non-SI unit of mass in terms of which the masses of individual atoms and molecules are expressed. Unified atomic mass unit is defined as one twelfth of the mass of an unbound atom of the carbon-12 nuclide, the predominant isotope of carbon, at rest and in its ground state. It is equal to 1.6606x10(E-27) kg (approximately).	u	Atomic Mass Unit || Dalton	
C176677	PQ/CMC Units of Measure Terminology	C41139	Meter	A unit of linear measure in the metric system, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). A meter is defined as the length of the path traveled by light in a vacuum during a time interval of 1/299 792 458 of a second and is equal to 1.093 61 yards.	m	meter	
C176677	PQ/CMC Units of Measure Terminology	C42535	Second	A unit of time, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). The second is the duration of 919 263 177 0 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the caesium 133 atom in its ground state at 0 K. According to the convention, 60 seconds constitute one minute; 3,600 seconds constitute one hour.	s	second	
C176677	PQ/CMC Units of Measure Terminology	C42537	Kelvin	A basic unit of thermodynamic temperature, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). It is 1/273.16th of the thermodynamic temperature of the triple point of water. This sets the size of the kelvin unit for temperature differences and defines the thermodynamic temperature of an equilibrium mixture of waters ice-liquid-vapor as 273.16 K, where 0 K is the lowest possible temperature ("absolute zero").	K	degree Kelvin	
C176677	PQ/CMC Units of Measure Terminology	C42539	Mole	A unit of amount of substance, one of the seven base units of the International System of Units (Systeme International d'Unites, SI). It is the amount of substance that contains as many elementary units as there are atoms in 0.012 kg of carbon-12. When the mole is used, the elementary entities must be specified and may be atoms, molecules, ions, electrons, other particles, or specified groups of such particles.	mol	mole	
C176677	PQ/CMC Units of Measure Terminology	C42543	Radian	A SI-derived unit of plane angle measurement defined and named by James Thomson in 1873. One radian is the plane angle between two radii of a circle that cuts off on the circumference an arc equal in length to the radius. There are 2pi radians in a complete circle. SI units: m/m = 1.	rad	radian	
C176677	PQ/CMC Units of Measure Terminology	C42546	Newton	A SI derived unit of force. The force which, when applied in a vacuum to a body having a mass of one kilogram, causes an acceleration of one meter per second squared. It is equal to 10E5 dynes.	N	Newton	
C176677	PQ/CMC Units of Measure Terminology	C42559	Degree Celsius	A unit of temperature of the temperature scale designed so that the freezing point of water is 0 degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current official definition of the Celsius sets 0.01 C to be at the triple point of water and a degree to be 1/273.16 of the difference in temperature between the triple point of water and absolute zero. One degree Celsius represents the same temperature difference as one Kelvin.	Cel	degree Celsius	
C176677	PQ/CMC Units of Measure Terminology	C42569	Square Meter	A SI unit of area measurement equal to a square whose sides are one meter long. Square meter is equal to 10,000 square centimeters; 0.01 are; 1.196 square yards; 10.76 square feet; 1550 square inches.	m2	square meter	
C176677	PQ/CMC Units of Measure Terminology	C42570	Cubic Meter	A SI unit of volume or capacity equal to the volume of a cube with edges one meter in length. It is equal to 1,000 liters; 1,000 cubic decimeters; 10(e+6) cubic centimeters; 25.3 cubic feet; 6.29 barrels.	m3	cubic meter	
C176677	PQ/CMC Units of Measure Terminology	C44277	Degree Fahrenheit	A unit of temperature of the temperature scale designed so that the freezing point of water is 32 degrees and the boiling point is 212 degrees, placing the boiling and melting points of water 180 degrees apart. One degree Fahrenheit is 5/9ths of a kelvin (or of a degree Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius.	[degF]	degree Fahrenheit	
C176677	PQ/CMC Units of Measure Terminology	C45997	pH	Quantity of dimension one used to express on a scale from 0 to 14 the amount-of-substance concentration of hydrogen ion of dilute aqueous solution, calculated as the logarithm of the reciprocal of hydrogen-ion concentration in gram atoms per liter.	[pH]	pH	
C176677	PQ/CMC Units of Measure Terminology	C48152	Microgram	A metric unit of mass equal to one millionth of a gram or one thousandth of a milligram.	ug	microgram	
C176677	PQ/CMC Units of Measure Terminology	C48153	Microliter	A unit of volume accepted for use with the SI and equal to one millionth of a liter (10E-6 liter).	uL	microliter	
C176677	PQ/CMC Units of Measure Terminology	C48154	Minute	A unit measure of time equal to 60 seconds.	min	minute	
C176677	PQ/CMC Units of Measure Terminology	C48155	Gram	The metric unit of mass equal to one thousandth of a kilogram. One gram equals approximately 15.432 grains or 0.035 273 966 ounce.	g	gram	
C176677	PQ/CMC Units of Measure Terminology	C48479	Can Dosing Unit	A dosing unit equal to the amount of active ingredient(s) contained in a can.	{can}	can	
C176677	PQ/CMC Units of Measure Terminology	C48500	Inch	A traditional unit of length equal to 1/12 of a foot or 2.54 centimeters.	[in_i]	inch	
C176677	PQ/CMC Units of Measure Terminology	C48505	Liter	The non-SI unit of volume accepted for use with the SI. One liter is equal to cubic decimeter, or one thousandth of cubic meter, or 1000 cubic centimeters, or approximately 61.023 744 cubic inches.	L	liter	
C176677	PQ/CMC Units of Measure Terminology	C48509	Micromole	A unit of amount of substance equal to a millionth of a mole.	umol	micromole	
C176677	PQ/CMC Units of Measure Terminology	C48510	Micron	A unit of length in metric system equal to 10E-6 meter, or micrometer.	um	micrometer || micron	
C176677	PQ/CMC Units of Measure Terminology	C48513	Millimole	A unit of amount of substance equal to 0.001 mole.	mmol	millimole	
C176677	PQ/CMC Units of Measure Terminology	C48516	Nanogram	The metric unit of mass equal to one billionth of a gram (10E-9 gram) or one thousandth of a milligram.	ng	nanogram	
C176677	PQ/CMC Units of Measure Terminology	C48517	Nanomole	A unit of amount of substance equal to 10E-9 mole.	nmol	nanomole	
C176677	PQ/CMC Units of Measure Terminology	C48519	Ounce	The traditional unit of mass. The avoirdupois ounce is equal to 1/16 pound, or 28.349 5 grams, or 0.911 457 troy ounce.	[oz_av]	ounce	
C176677	PQ/CMC Units of Measure Terminology	C48523	Part Per Million	A unit of proportion equal to 10E-6.	[ppm]	parts per million	
C176677	PQ/CMC Units of Measure Terminology	C48527	Percent Mass per Volume	A unit of percentage concentration expressed as a fraction of a component by mass in the entire volume of a resulting mixture. The standard conditions for temperature and pressure apply. The mass-volume percentage is used for liquid solute/solution systems and systems containing solid phase components. The concept also refers to the weight-volume percentage concentration given that standard values for specific gravity of the solute are used.	%{WeightToVolume}	percent weight per volume	
C176677	PQ/CMC Units of Measure Terminology	C48528	Percent Mass per Mass	A unit of percentage concentration expressed as a fraction of a solute by mass in the entire mass of a resulting solution. The concept also refers to the weight-weight percentage concentration given that standard values for specific gravity of the solute and the solution are used.	%{WeightToWeight}	percent weight/weight	
C176677	PQ/CMC Units of Measure Terminology	C48529	Pint	A United States liquid unit equal to 16 fluid ounces; two pints equal one quart.	[pt_us]	pints (US Dry)	
C176677	PQ/CMC Units of Measure Terminology	C48531	Pound	The traditional unit of mass. By international agreement, one avoirdupois pound is equal to exactly 0.453 592 37 kilogram, 16 ounces, or 1.215 28 troy pounds.	[lb_av]	pound	
C176677	PQ/CMC Units of Measure Terminology	C48542	Tablet Dosing Unit	A dosing unit equal to the amount of active ingredient(s) contained in a tablet.	{tbl}	tablet	
C176677	PQ/CMC Units of Measure Terminology	C48551	Vial Dosing Unit	A dosing unit equal to the amount of active ingredient(s) contained in a single vial.	{vial}	vial	
C176677	PQ/CMC Units of Measure Terminology	C48570	Percent Unit	A unit for expressing a number as a fraction of hundred (on the basis of a rate or proportion per hundred).	%	percent	
C176677	PQ/CMC Units of Measure Terminology	C48571	Percent Volume per Volume	A unit of percentage concentration expressed as a fraction of a component by volume s in the entire volume of a resulting mixture. The unit denotes a number of milliliters of a solute per 100 milliliters of solution. The standard conditions for temperature and pressure apply.	%{VolumeToVolume}	percent volume per volume	
C176677	PQ/CMC Units of Measure Terminology	C48579	International Unit	The unitage assigned by the WHO to International Biological Standards - substances, classed as biological according to the criteria provided by WHO Expert Committee on Biological Standardization (e.g. hormones, enzymes, and vaccines), to enable the results of biological and immunological assay procedures to be expressed in the same way throughout the world. The definition of an international unit is generally arbitrary and technical, and has to be officially approved by the International Conference for Unification of Formulae.	[IU]	international unit	
C176677	PQ/CMC Units of Measure Terminology	C48580	Gallon US	The US unit of liquid volume legally defined as 3785.411784 milliliters (3.785 411 784 liters), or 231 cubic inches. The US gallon holds 4 liquid quarts; the gallon of water gallon weighs approximately 8.33 pounds.	gal	gallon	
C176677	PQ/CMC Units of Measure Terminology	C49668	Centimeter	A basic unit of length in the former CGS version of metric system, equal to one hundredth of a meter or approximately 0.393 700 787 inch.	cm	centimeter	
C176677	PQ/CMC Units of Measure Terminology	C64551	Picogram	The metric unit of mass equal to one trillionth of a gram (10E-12 gram).	pg	picogram	
C176677	PQ/CMC Units of Measure Terminology	C64778	Enzyme Unit	A unit of catalytic activity measurement defined as the quantity of a particular enzyme that catalyzes the transformation of one micromole of the substrate per minute under standard conditions for specified assay system. The usage of this unit is discouraged in favor of the katal by International Federation of Clinical Chemistry and Laboratory Medicine due to lack of its coherence with the SI system. One enzyme unit is equal to 16.667 nanokatals.	U	catalytic activity unit	
C176677	PQ/CMC Units of Measure Terminology	C65045	Picomole	A unit of amount of substance equal to a trillionth (10E-12) of a mole.	pmol	picomole	
C176677	PQ/CMC Units of Measure Terminology	C66832	One	The smallest natural number and quantity it denotes: a single entity, unit, or object.	1*		
C176677	PQ/CMC Units of Measure Terminology	C67015	Milligram per Deciliter	A unit of mass concentration defined as the concentration of one milligram of a substance in unit volume of the mixture equal to one cubic deciliter or 100 cubic centimeters. It is also a unit of mass density (volumic mass) defined as the density of substance which mass equal to one milligram occupies the volume one cubic deciliter or 100 cubic centimeters.	mg%	milligram per 100 milliliters of solution	
C176677	PQ/CMC Units of Measure Terminology	C67196	British Thermal Unit	A non-SI unit of energy equal to the amount of heat required to raise the temperature of one pound avoirdupois of air-free water by one degree Fahrenheit at a constant pressure of one atmosphere. The value of the unit depends on the initial temperature of the water and varies in the range of approximately 1.054 - 1.060 joules.	[Btu]	British Thermal Unit	
C176677	PQ/CMC Units of Measure Terminology	C67318	Milliosmole	A unit of osmotic pressure equal to one thousandth of osmole or osmotic pressure of 0.001 molar solution of a substance that does not dissociate.	mosm	milliosmole	
C176677	PQ/CMC Units of Measure Terminology	C67328	Nanometer	A metric unit of length equal to one billionth of a meter (10E-9 meter). Nanometer is used as a unit for light wavelength measurement.	nm	nanometer	
C176677	PQ/CMC Units of Measure Terminology	C67334	Pound per Square Inch	A traditional unit of pressure equivalent to 6.894757 kilopascals, or 703.0696 kilograms per square meter, or 51.71507 millimeters of mercury.	[psi]	pounds per square inch	
C176677	PQ/CMC Units of Measure Terminology	C68667	Degree Unit of Plane Angle	A unit of plane angle measurement equal to the length of the arc cut out by the angle, divided by the circumference of the circle, and multiplied by 360. The symbol for degrees is a small superscript circle. One radian is about 57 degrees and one degree is pi/180 radians.	deg	degrees to rotation	
C176677	PQ/CMC Units of Measure Terminology	C68742	Colony Forming Unit	The minimum number of separable cells which is able to produce a detectable colony of progeny. Examples of CFU usage include, but are not limited to, the measurement of the number of viable bacteria present in the environment, and the ability of stem cells to produce cells of single or multiple lineages.	[CFU]	colony forming units	
C176677	PQ/CMC Units of Measure Terminology	C69092	Centipoise	A CGS unit of dynamic viscosity equal to 10E-3 pascal second.	cP	centipoise	
C176677	PQ/CMC Units of Measure Terminology	C69112	Part per Thousand	A unit of proportion equal to 10E-3.	[ppth]	parts per thousand	
C176677	PQ/CMC Units of Measure Terminology	C69118	Quart Dry US	A unit of volume in US customary measure system for dry volumes equal to 67.201 cubic inches, or approximately 1.101 221 liters.	[qt_us]	quarts (US Dry)	
C176677	PQ/CMC Units of Measure Terminology	C70471	Kilogram-Force	A deprecated unit of force defined as a force that produces an acceleration equal to the acceleration of gravity when acting on a mass of one kilogram. One kilogram-force is equal to 9.80665 newtons.	kgf	kilopond	
C176677	PQ/CMC Units of Measure Terminology	C70565	Part Per Billion	A unit of proportion equal to 10E-9.	[ppb]	parts per billion	
C176677	PQ/CMC Units of Measure Terminology	C70566	Part Per Trillion	A unit of proportion equal to 10E-12.	[pptr]	parts per trillion	
C176677	PQ/CMC Units of Measure Terminology	C73783	Unit per Square Meter per Day	An arbitrary unit of substance rate expressed in unit(s) per square meter per period of time equal to twenty-four hours.	(m2.d)	meter squared in 24 hours	
C176677	PQ/CMC Units of Measure Terminology	C75765	Arbitrary Unit	A single undivided thing (unit) based on or subject to individual judgment or preference, and not by necessity, reason, or principle.	[arb'U]		
C176677	PQ/CMC Units of Measure Terminology	C92953	Amb a 1 Unit	An arbitrary unit for the measurement of Amb a 1 (or Antigen E), a 38 kD glycoprotein that is the major allergen in short ragweed pollen allergen extracts.	[Amb'a'1'U]	Amb a 1 units	
C176677	PQ/CMC Units of Measure Terminology	C96599	Ehrlich Unit	A unit of measure equal to one milligram of urobilinogen per deciliter.	[EU]	Ehrlich unit	
C185181	PQ/CMC Expiration Date Classification Terminology	C185182	Master File or Application Approved Indicator	An approved indicator for an application or a master file when the Expiration Date Classification or Retest Date Classification is set to "Approved".	Approved		After an application or a master file has been approved, then the Expiration Date Classification or Retest Date Classification is set to "Approved".
C185181	PQ/CMC Expiration Date Classification Terminology	C185186	Adequate Substance Process Understanding	The applicant has appropriate process understanding to demonstrate that the quality of the subsequent API can be satisfactorily controlled. Adequate applies to substances only.	Adequate		The applicant has appropriate process understanding to demonstrate that the quality of the subsequent API can be satisfactorily controlled. Adequate applies to substances only.
C185181	PQ/CMC Expiration Date Classification Terminology	C185188	Proposed Substance Date Change	For a Supplement that's changing the expiration date or the retest date that is already classified as "Approved" for the drug product or drug substance, the changed expiration date classification or retest date classification would be "Proposed".	Proposed		For a Supplement that's changing the expiration date or the retest date that is already classified as "Approved" for the drug product or drug substance, the changed expiration date classification or retest date classification would be "Proposed".
C185181	PQ/CMC Expiration Date Classification Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C185183	PQ/CMC Retest Date Classification Terminology	C185182	Master File or Application Approved Indicator	An approved indicator for an application or a master file when the Expiration Date Classification or Retest Date Classification is set to "Approved".	Approved		After an application or a master file has been approved, then the Expiration Date Classification or Retest Date Classification is set to "Approved".
C185183	PQ/CMC Retest Date Classification Terminology	C185186	Adequate Substance Process Understanding	The applicant has appropriate process understanding to demonstrate that the quality of the subsequent API can be satisfactorily controlled. Adequate applies to substances only.	Adequate		The applicant has appropriate process understanding to demonstrate that the quality of the subsequent API can be satisfactorily controlled. Adequate applies to substances only.
C185183	PQ/CMC Retest Date Classification Terminology	C185188	Proposed Substance Date Change	For a Supplement that's changing the expiration date or the retest date that is already classified as "Approved" for the drug product or drug substance, the changed expiration date classification or retest date classification would be "Proposed".	Proposed		For a Supplement that's changing the expiration date or the retest date that is already classified as "Approved" for the drug product or drug substance, the changed expiration date classification or retest date classification would be "Proposed".
C185183	PQ/CMC Retest Date Classification Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C185189	PQ/CMC Interval Description Code Terminology	C96150	Immediate Testing	Sample is tested immediately.	Immediate Testing		Sample is tested immediately.
C185189	PQ/CMC Interval Description Code Terminology	C96151	Delayed Testing	Sample is not tested immediately.	Delayed Testing		Sample is not tested immediately.
C185189	PQ/CMC Interval Description Code Terminology	C96153	Frozen Delayed Testing	Sample is frozen and not tested immediately.	Frozen Delayed Testing		Sample is frozen and not tested immediately.
C185189	PQ/CMC Interval Description Code Terminology	C96154	Ambient Delayed Testing	Sample is stored at ambient conditions and not tested immediately.	Ambient Delayed Testing		Sample is stored at ambient conditions and not tested immediately.
C185189	PQ/CMC Interval Description Code Terminology	C96155	Refrigerated Delayed Testing	Sample is refrigerated and not tested immediately.	Refrigerated Delayed Testing		Sample is refrigerated and not tested immediately.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203348	Hard Gelatin Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of gelatin in which one or more drug substances and/or inert materials are enclosed.	Hard Gelatin Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of gelatin in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203349	Hard HPMC Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of hydroxypropyl methylcellulose (HPMC) in which one or more drug substances and/or inert materials are enclosed.	Hard HPMC Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of hydroxypropyl methylcellulose (HPMC) in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203350	Hard Pullulan Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of pullulan in which one or more drug substances and/or inert materials are enclosed.	Hard Pullulan Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of pullulan in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203351	Hard PVA Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of polyvinyl alcohol (PVA) copolymer in which one or more drug substances and/or inert materials are enclosed.	Hard PVA Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of polyvinyl alcohol (PVA) copolymer in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203352	Hard Starch Capsule Shell	A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of starch in which one or more drug substances and/or inert materials are enclosed.	Hard Starch Capsule Shell		A cylindrical shaped casing with rounded ends consisting of two parts, a body and cap, and composed largely of starch in which one or more drug substances and/or inert materials are enclosed.
C203345	PQ/CMC Capsule Shell Classification Terminology	C203353	Soft Gelatin Capsule Shell	A one-piece, hermetically sealed soft gelatin casing with liquid, suspension, or semisolid materials enclosed.	Soft Gelatin Capsule Shell		A one-piece, hermetically sealed soft gelatin casing with liquid, suspension, or semisolid materials enclosed.
C203346	PQ/CMC Release Mechanism Terminology	C203359	Matrix Drug Release	Drug release controlled by homogeneous distribution of the drug throughout a matrix. Drug molecules are released as the matrix dissolves.	Matrix		Drug release controlled by homogeneous distribution of the drug throughout a matrix. Drug molecules are released as the matrix dissolves.
C203346	PQ/CMC Release Mechanism Terminology	C203360	Osmotic Pump Drug Release	Drug release controlled by an osmotic agent that acts to imbibe water from the surrounding medium via a semipermeable membrane which is permeable to water but impermeable to drug. The delivery of the active agent from the device is controlled by water influx across the semipermeable membrane forcing the drug out of an orifice in the device.	Osmotic Pump		Drug release controlled by an osmotic agent that acts to imbibe water from the surrounding medium via a semipermeable membrane which is permeable to water but impermeable to drug. The delivery of the active agent from the device is controlled by water influx across the semipermeable membrane forcing the drug out of an orifice in the device.
C203346	PQ/CMC Release Mechanism Terminology	C203361	Reservoir Drug Release	Drug release controlled by the thickness and the dissolution rate of the encapsulating membrane surrounding the drug core.	Reservoir		Drug release controlled by the thickness and the dissolution rate of the encapsulating membrane surrounding the drug core.
C203347	PQ/CMC Substance Name Type Terminology	C142585	International Nonproprietary Name	A unique, internationally consistent and globally recognized name which identifies pharmaceutical substances or active pharmaceutical ingredients and is public property.	INN		International Nonproprietary Name (INN) is a unique name that is globally recognized and is public property.
C203347	PQ/CMC Substance Name Type Terminology	C203354	Company Identifier	An identifier assigned by a company.	Company ID/Code		An identifier or code assigned by the company.
C203347	PQ/CMC Substance Name Type Terminology	C203355	GSRS Preferred Term	The preferred term, preferred substance name and display name identified as PT within FDA Global Substance Registration System (GSRS).	GSRS Preferred Term		The default display name identified within FDA Global Substance Registration System (GSRS).
C203347	PQ/CMC Substance Name Type Terminology	C203356	IUPAC Name	A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC).	IUPAC Name		A name assigned to a chemical substance according to the systematic nomenclature rules defined by the International Union of Pure and Applied Chemistry (IUPAC).
C203347	PQ/CMC Substance Name Type Terminology	C203357	Chemical Systematic Name	A name derived directly from the chemical structure.	Systematic Name		A name derived directly from the chemical structure.
C203347	PQ/CMC Substance Name Type Terminology	C203358	USP-NF Established Name	A unique nonproprietary name assigned to drugs and biologics by the United States Pharmacopeia (USP) or excipients by the National Formulary (NF).	USP-NF Established Name		A unique nonproprietary name assigned to drugs and biologics by the United States Pharmacopeia (USP) or excipients by the National Formulary (NF).
C203347	PQ/CMC Substance Name Type Terminology	C54682	CAS Number	A unique numerical identifier assigned, by the Chemical Abstract Service (CAS), a division of the American Chemical Society, to chemical compounds, polymers, biological sequences, mixtures, and alloys.	CAS Number		A unique numerical identifier assigned by the Chemical Abstract Service (CAS), a division of the American Chemical Society, to chemical compounds, polymers, biological sequences, mixtures, and alloys.
C203347	PQ/CMC Substance Name Type Terminology	C71898	Proprietary Name	The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.	Proprietary Name	Brand	The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.
C203347	PQ/CMC Substance Name Type Terminology	C95517	ISBT-128 Donation Identification Number	A globally unique identifier that is assigned to each collection and each pooled product. The identifier is composed of four parts: a Facility Identification Number (FIN), a year of assignment, a serial number, and flag characters.	ISBT-128 DIN		A globally unique identifier that is assigned to each collection and each pooled product. The identifier is composed of four parts: a Facility Identification Number (FIN), a year of assignment, a serial number, and flag characters.
C203347	PQ/CMC Substance Name Type Terminology	C96973	United States Adopted Name	A unique nonproprietary name assigned to drugs and biologics by the United States Adopted Names Council (USAN).	USAN		A unique nonproprietary name assigned to drugs and biologics by the United States Adopted Names Council (USAN).
C203347	PQ/CMC Substance Name Type Terminology	C97054	Generic Name	A non-branded or registered name that meant for common use.	Nonproprietary Name	Common Name || Generic Name	A non-branded or registered name meant for common use.
C203777	PQ/CMC Ingredient Location Terminology	C203881	Active Core Granule	A granule core containing an active pharmaceutical ingredient (API) as opposed to the API being in the coating and not in the core.	Active core/granulate		The location of the ingredient of interest is within a starter core (granulate, bead or tablet) with no applied coating.
C203777	PQ/CMC Ingredient Location Terminology	C203882	Extragranular Ingredient	An ingredient that is added after granulation and located outside of the granule.	Extragranular		The location of the ingredient of interest is external to the granules (granulates)
C203777	PQ/CMC Ingredient Location Terminology	C203883	Intragranular Ingredient	An ingredient that is added before granulation and located within the granule.	Intragranular		The location of the ingredient of interest is within the granules (granulates)
C203778	PQ/CMC Release Profile Terminology	C42669	Immediate Release Dosage Form	A solid, semi-solid, solution or suspension that is designed to release its active and/or inert ingredient(s) upon administration with no enhanced, delayed or extended release effect.	Immediate Release Profile		A design in which no deliberate effort has been made to modify the API release rate. In the case of capsules and tablets, the inclusion or exclusion of a disintegrating agent is not interpreted as a modification.
C203778	PQ/CMC Release Profile Terminology	C42713	Extended Release Dosage Form	A solid, semi-solid, solution or suspension designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.	Extended-Release Profile		A design which makes the drug substance available over a prolonged period following administration, compared to that observed or anticipated for an immediate-release profile.
C203778	PQ/CMC Release Profile Terminology	C42730	Delayed Release Dosage Form	A solid, semi-solid, solution or suspension that has been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration.	Delayed-Release Profile		A design which impedes release of the drug substance for some period of time after initial administration
C203778	PQ/CMC Release Profile Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	Not Applicable	NA	Determination of a value is not relevant in the current context.
C203779	PQ/CMC Coating Purpose Terminology	C203884	Appearance Promoting Coating	A coating applied to promote a particular appearance of a medication.	Appearance/Identification		A coating applied to achieve a specified presentation.
C203779	PQ/CMC Coating Purpose Terminology	C203885	Consumption Promoting Coating	A coating applied to promote consumption of a medication.	Consumption Enhancement		A coating applied to facilitate swallowing (e.g., making the tablet smoother, etc.).
C203779	PQ/CMC Coating Purpose Terminology	C203886	Isolate Promoting Coating	A coating applied to isolate one or more components of a medication.	Content Isolation		A coating applied to one or more components of a tablet (e.g., beads or granules) to mitigate interaction with other components.
C203779	PQ/CMC Coating Purpose Terminology	C203887	Delayed Release Coating	A coating applied to delay the release of the medication.	Delayed Release		A coating applied to achieve a delayed release profile.
C203779	PQ/CMC Coating Purpose Terminology	C203888	Drug Layering Coating	A coating applied to define a layer(s) within a medication.	Drug Layering		A coating applied to deposit API(s) on a product or component surface (i.e., tablet, bead, blend, or other intermediates).
C203779	PQ/CMC Coating Purpose Terminology	C203889	Extended Release Coating	A coating applied to extend the release of the medication.	Extended Release		A coating applied to achieve an extended-release profile.
C203779	PQ/CMC Coating Purpose Terminology	C203890	Irritant Suppression Coating	A coating applied to suppress drug-induced irritation.	Irritant Suppression		A coating applied to reduce dispersion within the GI tract (e.g., prevention of drug-induced irritation at a specific site such as NSAIDs with an enteric coating).
C203779	PQ/CMC Coating Purpose Terminology	C203891	Odor Masking Coating	A coating applied to mask an odor.	Odor Masking		A coating applied to obscure or enhance olfaction.
C203779	PQ/CMC Coating Purpose Terminology	C203892	Protective Coating	A coating applied to protect components of a medication.	Protective		A coating applied to ensure the properties of the contents are not impacted prior to administration (e.g., by moisture, air, light, handling, transportation, etc.) and/or after administration (e.g., by inactivation of drug in the stomach such as acid-labile APIs)
C203779	PQ/CMC Coating Purpose Terminology	C203893	Seal Coating	A coating applied to seal the contents of a medication.	Seal		A coating applied to improve drug product appearance, handling, and/or stability of the dosage form, but having no measurable effect on biopharmaceutical properties of the dosage form.
C203779	PQ/CMC Coating Purpose Terminology	C203894	Site Delivery Coating	A coating applied to ensure intended delivery site of medication.	Site of Action		A coating applied to ensure delivery of API to the site of action (e.g., colon delivery).
C203779	PQ/CMC Coating Purpose Terminology	C203895	Taste Masking Coating	A coating applied to mask the taste of a medication.	Taste Masking		A coating applied to obscure or enhance gustation.
C203780	PQ/CMC Product Part Type Terminology	C202489	Dispersion Dosage Form	A substance intended for administration as a dispersion.	Dispersion		A constituent in which particles are uniformly distributed throughout a liquid.
C203780	PQ/CMC Product Part Type Terminology	C203896	Blended Dry Mixture	A medication composed of a dry mixture of ingredients.	Blend		A constituent composed of a dry mixture of ingredients (e.g., API and/or excipients) mixed in pharmaceutical processing equipment.
C203780	PQ/CMC Product Part Type Terminology	C203897	Capsule Shell	The outer coating of a capsule.	Capsule Shell		An outer skin in which a medicinal substance is contained.
C203780	PQ/CMC Product Part Type Terminology	C203898	Minitablet Dosage Form	A dosage form composed of compressed tablets with a typical diameter of 1 to 4 mm. Minitablets can in turn be processed into various formulations and/or can be used in a composite dosing form for multiparticulate dosing.	Minitablets		A constituent composed of small tablets that are filled into capsules.
C203780	PQ/CMC Product Part Type Terminology	C25450	Coat	A thin outer layer or film covering something.	Coating		A constituent composed of a thin layer covering the outer surface.
C203780	PQ/CMC Product Part Type Terminology	C42890	Bead Dosage Form	A solid in the shape of a small sphere.	Bead		A constituent composed of small sphere(s).
C203780	PQ/CMC Product Part Type Terminology	C42938	Granule Dosage Form	A solid composed of small particles or grains.	Granules		A constituent composed of dry aggregates of powder particles that may contain one or more APIs, with or without other ingredients.
C203780	PQ/CMC Product Part Type Terminology	C42986	Solution Dosage Form	A clear, homogeneous liquid composed of one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.	Solution		A constituent that is a clear, homogeneous liquid containing one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
C203780	PQ/CMC Product Part Type Terminology	C42998	Tablet Dosage Form	A solid composed of a mixture of that active and/or inert ingredient(s) are pressed or compacted together, usually in the form of a relatively flat and round, square or oval shape.	Tablet		A constituent prepared from powders or granules by compaction (with or without API and/or excipients). The tablet may be coated or uncoated.
C203780	PQ/CMC Product Part Type Terminology	C66831	Layer	A relatively thin sheetlike expanse or region lying over or under another.	Layer		A sheet, quantity, or thickness of material, typically one of several.
C204862	PQ/CMC Test Subcategory Terminology	C134002	Residual Solvent Test	Tests performed to determine if organic volatile chemicals that are used or produced in manufacture of drug substance or excipients, or in the preparation of drug products are present in the pharmaceuticals.	Residual Solvent		Tests performed to determine if organic volatile chemicals that are used or produced in manufacture of drug substance or excipients, or in the preparation of drug products are present in the pharmaceuticals.
C204862	PQ/CMC Test Subcategory Terminology	C134115	Uniformity of Dosage Units Analysis	An evaluation of the content uniformity in terms of amount of drug substance among dosage units.	Uniformity of Dosage Unit		Tests of the variability each of the dosage unit's dispensed dose.
C204862	PQ/CMC Test Subcategory Terminology	C134254	Impurities/Degradation Products/Related Substances Test	Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material.	Impurities/Degradation Products/Related Substances		Tests that establish the characteristic and uniqueness of the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present. Includes leachables and extractables.
C204862	PQ/CMC Test Subcategory Terminology	C134261	Clarity of Solution Measurement	Measurement of the turbidity of the solution.	Clarity of Solution		Measurement of the turbidity of the solution or qualitative or quantitative measurement of degree of opalescence of a solution, including instrumental measurement of the light reflected by the solution.
C204862	PQ/CMC Test Subcategory Terminology	C134262	Color of Solution Measurement	The color of a solution compared to that of a standard solution.	Color of Solution		The use of visual perception to indicate of purity and/or a means to identify contamination.
C204862	PQ/CMC Test Subcategory Terminology	C138990	Product Description/Appearance Assessment	Tests using visual inspection to assess the physical state and color of the drug substance or product.	Description/Appearance		Tests using visual inspection to assess the physical state and color of the drug substance or product.
C204862	PQ/CMC Test Subcategory Terminology	C139027	Odor Detection	Determining any smells associated with a material.	Odor		Testing via the sense of smell.
C204862	PQ/CMC Test Subcategory Terminology	C16643	Protein Glycosylation	The covalent chemical or post-translational biochemical addition of carbohydrate or glycosyl groups to peptides or proteins by glycosyl transferases.	Glycosylation		Post translation modification due to addition of sugar.
C204862	PQ/CMC Test Subcategory Terminology	C171277	Nucleic Acid Concentration Measurement	The measured concentration of nucleic acid in a sample.	Nucleic Acid Content		Tests designed to reveal the presence of a particular nucleic acid from a test sample.
C204862	PQ/CMC Test Subcategory Terminology	C204845	Active Ingredient Assay	Qualitative or quantitative measurements of an active ingredient of a pharmacologic product.	Active Ingredient Content		Tests that verify the content and potency of a pharmaceutical substance that is intended to have an effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to impact a structure or function of the body.
C204862	PQ/CMC Test Subcategory Terminology	C204890	Chemical Impurity Test	Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material.	Impurity Chemical		Analytical procedures to establish chemical purity by determining the presence of a component of the material that is not the chemical entity defined as the material.
C204862	PQ/CMC Test Subcategory Terminology	C205001	Adventitious Agent Assay	In vitro and in vivo assays for detection of potentially harmful unintended agents.	Adventitious Agents (Safety)		In vitro and in vivo assays for detection of unintended agents such as viral, bacterial, fungal agents which have undesirable adverse impact on patient's health.
C204862	PQ/CMC Test Subcategory Terminology	C205002	Amidation Assay	An assessment of the degree to which bioactive peptides have undergone amidation, the process by which a side-chain carboxyl group acquires an alpha-amide.	Amidation		Testing for and acid containing residue conversion to an amide.
C204862	PQ/CMC Test Subcategory Terminology	C205003	Bioburden Test	The determination of the type and number of viable microorganisms in a test sample	Bioburden		Test that screens for aerobic mesophilic bacteria and fungi.
C204862	PQ/CMC Test Subcategory Terminology	C205004	Blend Uniformity Test	A testing process that evaluates the consistency of a blended sample of active ingredients and excipients (or inactive ingredients) of a drug product.	Blend Uniformity		Test to ensure the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product.
C204862	PQ/CMC Test Subcategory Terminology	C205005	Capsule Lock Length Measurement	The straight line measurement from the longest edge-to-edge distance through a capsule body and cap that have been coupled such that the locking rings are sealed as designed.	Lock Length		The length of a straight line measurement from the longest edge-to-edge distance through a Capsule body and cap that have been coupled such that the locking rings are sealed as designed.
C204862	PQ/CMC Test Subcategory Terminology	C205006	Cell and Gene Therapy Product Characterization Assay	Assay to determine or quantify the functionality of cellular and genetic therapy products.	Cell and Gene Therapy Product Characterization Assay		Tests to determine Cell and Gene therapy product properties. Examples: Viability, Cell number, Morphology, Cell surface markers, Secreted molecules, Gene expression, Genetic stability, percent recovery, gene expression, cell surface marker expression, proliferation capacity, total cell number, cell morphology, cell distribution in scaffold, total volume of scaffold, cellular pattern, vector genome concentration, vector infectious titer assay, replication competence assay, DNA homogeneity, transduction efficiency, vector genome concentration, vector infectious titer assay, Replication competence assay.
C204862	PQ/CMC Test Subcategory Terminology	C205007	Counterion Content Assessment	Tests to detect and quantify counterions in a substance.	Counterion Content		Tests that measure the secondary ion of a drug salt.
C204862	PQ/CMC Test Subcategory Terminology	C205008	Deamidation Assessment	An assessment of the degree to which bioactive peptides have undergone deamidation, the process by which a side-chain amide group of asparagine is converted into a carboxylic acid.	Deamidation		Testing for an amide residue conversion to an acid.
C204862	PQ/CMC Test Subcategory Terminology	C205009	Dose Orifice Depth Drilled Measurement	The depth measurement of the penetration of the hole drilled in the unit dose as measured from the outer edge to the deepest point of penetration.	Orifice Depth		The measurement of the penetration of the hole drilled in the unit dose as measured from the outer edge to the deepest point of penetration.
C204862	PQ/CMC Test Subcategory Terminology	C205010	Dose Orifice Diameter Drilled Measurement	The straight line length across the center of the hole drilled in the unit dose.	Orifice Diameter		The length of a straight line measurement across the center of the hole drilled in the unit dose.
C204862	PQ/CMC Test Subcategory Terminology	C205011	Dose Orifice Location Measurement	The position of hole drilled in the unit dose.	Orifice Location		The position of hole drilled in the unit dose.
C204862	PQ/CMC Test Subcategory Terminology	C205014	Elemental Impurity Analysis	An analytical chemistry methodology used to identify and quantify elemental contaminants in a test sample.	Elemental Impurity		Analytical procedures that determine the amount of single elements in drug products or drug product components.
C204862	PQ/CMC Test Subcategory Terminology	C205015	Excipient Measurement	Testing of the amount of material other than the active Ingredient or adjuvant in a product.	Excipient		Testing of the amount of material other than the active or adjuvant.
C204862	PQ/CMC Test Subcategory Terminology	C205016	Group Fill Substance Weight Measurement	The sum of fill substance weights of a collection of units.	Group Fill Weight		The sum of fill weights of material of interest across a specified collection of units
C204862	PQ/CMC Test Subcategory Terminology	C205017	Group Substance Weight Measurement	The sum of weights of a substance in a collection.	Group Weight		The sum of weights of material of interest across a specified collection of units
C204862	PQ/CMC Test Subcategory Terminology	C205018	Host Cell DNA Measurement	Measurement of DNA that comes from the host cells that were used to generate the viral particles.	Host Cell DNA		Measurement of DNA that comes from cell substrate used to make the viral particles.
C204862	PQ/CMC Test Subcategory Terminology	C205019	In Process Control Content Uniformity Tests	In-Process Control tests of the variability of individual dosage units during manufacture as informed by ASTM E2810.	IPC Content Uniformity		In-Process Control (IPC) tests of the variability of individual dosage units during manufacture as informed by ASTM E2810.
C204862	PQ/CMC Test Subcategory Terminology	C205020	In Vitro or In Vivo Test for Viral Contaminants	Test used to measure viral contamination both by in vitro and in vivo assay.	In Vitro or In Vivo Test for Viral Contaminants		Test used to measure viral contamination both by in vitro and in vivo assays
C204862	PQ/CMC Test Subcategory Terminology	C205021	Individual Substance Fill Weight Measurement	The substance fill weight of an individual unit.	Individual Fill Weight		The weight of material of interest within a single unit. Example: 1 gram (in each vial), 200 mg (in each capsule) note: could be a capsule, vial, or bottle.
C204862	PQ/CMC Test Subcategory Terminology	C205022	Individual Substance Weight Measurement 	The weight of a single unit of the substance.	Individual Weight		The weight of a single unit of the material of interest. Example: 800 mg tablet
C204862	PQ/CMC Test Subcategory Terminology	C205024	Metal Level Detection Test	Tests for metallic particles to confirm that they are not present in excess of specified levels.	Metal Detection		Tests for metallic particles to confirm that they are not present in excess of specified levels.
C204862	PQ/CMC Test Subcategory Terminology	C205025	Number of Dose Orifices Drilled Count	The total count of holes drilled in the unit dose.	Number of Orifices		The total count of holes drilled in the unit dose. [Source: SME Defined]
C204862	PQ/CMC Test Subcategory Terminology	C205028	Percent Conjugated Protein Measurement	A determination of the ratio of chemically conjugated proteins to the amount of total proteins, expressed as a percentage.	Percent Conjugate		Test to determine the percentage of total protein that functions in interaction with other (non-polypeptide) chemical groups attached by covalent bonding.
C204862	PQ/CMC Test Subcategory Terminology	C205031	Protein Sialylation	Post translational modification of proteins by sialylation.	Sialylation		Post translational modification of proteins by sialylation.
C204862	PQ/CMC Test Subcategory Terminology	C205033	Ribbon Density	The compactness of a continuous sheet of compressed material in preparation for subsequent processing.	Ribbon Density		The compactness of a continuous sheet of compressed material in preparation for subsequent processing.
C204862	PQ/CMC Test Subcategory Terminology	C205034	Ribbon Thickness	The dimension between two surfaces of a continuous sheet of compressed material in preparation for subsequent processing.	Ribbon Thickness		The dimension between two surfaces of a continuous sheet of compressed material in preparation for subsequent processing.
C204862	PQ/CMC Test Subcategory Terminology	C205035	Seam Thickness Measurement	The measurement of overlap common to two edges of the same material joined together.	Seam Thickness		The measurement of overlap common to two edges of the same material joined together. Example: 1 mm
C204862	PQ/CMC Test Subcategory Terminology	C205036	Shell Weight Measurement	The weight of outer casing of a pharmacologic product.	Shell Weight		The weight of outer casing ("shell") into which material of interest is filled. Example: 20 mg
C204862	PQ/CMC Test Subcategory Terminology	C205037	Single or Double Drilled Side Assessment	An observation if one or both sides of a unit dose have been drilled.	Drilled Side (Single or Double)		An observation if one or both sides of the unit dose has been drilled.
C204862	PQ/CMC Test Subcategory Terminology	C205038	Solvate Content Identification	An assay of water or solvent found in a crystal to identify any hydrates or solvates present.	Solvate Content		Identification of hydrates or solvates by the assay of water of crystallization or solvent found in the crystal.
C204862	PQ/CMC Test Subcategory Terminology	C205039	Specified Identified Impurity Test	Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and for which a structured characterization has been achieved.	Specified Identified Impurity		Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and for which a structured characterization has been achieved. Note: this includes degradation products for tests conducted on drug products.
C204862	PQ/CMC Test Subcategory Terminology	C205040	Specified Unidentified Impurity Test	Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and that is defined solely by qualitative analytical properties and lacks a structured characterization.	Specified Unidentified Impurity		Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time) due to the lack of achieving a structured characterization. Note: this includes degradation products for tests conducted on drug products.
C204862	PQ/CMC Test Subcategory Terminology	C205042	Tablet Thickness Measurement	The length of a straight line measurement from the shortest edge-to-edge distance through a tablet.	Tablet Thickness		The length of a straight line measurement from the shortest edge-to-edge distance through a Tablet.
C204862	PQ/CMC Test Subcategory Terminology	C205043	Tablet/Capsule Diameter Measurement	The length of a straight line measurement across the circular center of a tablet/capsule.	Tablet/Capsule Diameter		The length of a straight line measurement across the circular center of a Tablet/Capsule.
C204862	PQ/CMC Test Subcategory Terminology	C205044	Tablet/Capsule Length Measurement	The length of a straight line measurement from the longest edge-to-edge distance through the tablet/capsule.	Tablet/Capsule Length		The length of a straight line measurement from the longest edge-to-edge distance through the Tablet/Capsule.
C204862	PQ/CMC Test Subcategory Terminology	C205045	Target Group Product Weight Gain Percentage	A predetermined percentage weight increase for a set of units resulting from an action such as coating.	Target Group Weight Gain %		A predetermined percentage weight increases for a set of units resulting from of an action such as coating. Example: 3% (weight gain after coating) note: this can be associated with a bulk material or a single unit.
C204862	PQ/CMC Test Subcategory Terminology	C205047	Total Product Impurity above Threshold Assay	The sum of all impurities in a product at a level greater than the reporting threshold.	Total Impurities		The sum of all impurities at a level greater than (>) the reporting threshold. Note: this includes degradation products for tests conducted on drug products.
C204862	PQ/CMC Test Subcategory Terminology	C205048	Total Product Unknown Impurity Assay	The sum of unknown (unidentified) impurities in a new drug substance or product specification.	Total Unknown Impurities		The sum of unknown (unidentified) impurities in a new drug substance or drug product specification. Note: Total impurities includes all impurities while Total Unknown impurities only includes all the unknown impurities.
C204862	PQ/CMC Test Subcategory Terminology	C205050	Content Uniformity in Container	The consistency of an active ingredient throughout the container of the product.	Uniformity in Containers		The consistency of the active ingredient throughout multi-use containers such as tubes, and jars of semi-solids.
C204862	PQ/CMC Test Subcategory Terminology	C205051	Unspecified Product Impurity below ICH Identification Threshold	Identified unspecified impurities which are below the ICH (International Council for Harmonisation) identification threshold in a pharmacologic product.	Identified Impurity under IT, Monitored as Unspecified		Identification (chemical name and/or UNII code) of all the identified (known) impurities that are being controlled as "unspecified impurities" rather than "Specified Identified Impurity" due to the level being consistently below the ICH identification threshold (IT) value. Note: this includes degradation products for tests conducted on drug products.
C204862	PQ/CMC Test Subcategory Terminology	C205052	Unspecified Product Impurity Test	Testing for a product impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion.	Unspecified Impurity		Testing for an impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug substance or drug product specification. Note: this includes degradation products for tests conducted on drug products.
C204862	PQ/CMC Test Subcategory Terminology	C205053	Weight/Concentration Variation Test	The difference in weights or concentration of an ingredient in a finished pharmaceutical product.	Weight Variation		The difference in weights of the material of interest. Examples: 2%, 5 mg, 2.5 % note: may be a percent, a value, or a percent relative standard deviation. [Source: SME Defined]
C204862	PQ/CMC Test Subcategory Terminology	C205054	Thrombin Peptide Map	A representation of the composition of a protein resulting from cleavage of a test sample by thrombin.	Thrombin Peptide Map		Map of peptides derived from digestion of protein with thrombin.
C204862	PQ/CMC Test Subcategory Terminology	C205206	Average Fill Substance Weight Measurement	The sum of substance fill weights of material of interest across multiple units divided by the number of units included in the sum.	Average Fill Weight		The sum of fill weights of material of interest across multiple units divided by the number of units included in the sum.
C204862	PQ/CMC Test Subcategory Terminology	C205209	Average Substance Weight Measurement	The sum of weights of a substance across multiple units divided by the number of units included in the sum.	Average Weight		The sum of weights of material of interest across multiple units divided by the number of units included in the sum.
C204862	PQ/CMC Test Subcategory Terminology	C62352	Purity Assessment	A quantitative assessment of the homogeneity or uniformity of a mixture. Alternatively, purity refers to the degree of being free of contaminants or heterogeneous components.	Purity		Testing methods to identify actives and indirectly measure impurities that may be present in a medicine. Examples of analytical procedures for this test subcategory include SDS-PAGE and HPLC.
C204862	PQ/CMC Test Subcategory Terminology	C64858	Total Protein Measurement	A quantitative measurement of the amount of total protein present in a sample.	Total Protein		Test to determine total protein concentration in the product.
C204862	PQ/CMC Test Subcategory Terminology	C81183	Amino Acid Measurement	The measurement of the amount of amino acids in a biologic specimen.	Amino Acid Content		Methodology used to determine the amino acid composition or content of proteins, peptides, and other pharmaceutical preparations.
C205477	PQ/CMC Substance Classification Terminology	C103206	Structurally Diverse Substance	A type of polydisperse substance isolated from a single source that is a complex mixture which cannot be described as a limited set of single substance.	Structurally Diverse Substance		
C205477	PQ/CMC Substance Classification Terminology	C17021	Protein	A group of complex organic macromolecules composed of one or more chains (linear polymers) of alpha-L-amino acids linked by peptide bonds and ranging in size from a few thousand to over 1 million Daltons. Proteins are fundamental genetically encoded components of living cells with specific structures and functions dictated by amino acid sequence.	Protein		A group of complex organic macromolecules composed of one or more chains (linear polymers) of alpha-L-amino acids linked by peptide bonds and ranging in size from a few thousand to over 1 million Daltons. Proteins are fundamental genetically encoded components of living cells with specific structures and functions dictated by amino acid sequence.
C205477	PQ/CMC Substance Classification Terminology	C45305	Mixture	A substance consisting of two or more substances mixed together (not in fixed proportions and not with chemical bonding).	Mixture		A substance consisting of two or more substances mixed together (not in fixed proportions and not with chemical bonding).
C205477	PQ/CMC Substance Classification Terminology	C48803	Polymer	A substance made up of variable numbers of repeating structural units linked through covalent bonds.	Polymer		A substance made up of variable numbers of repeating structural units linked through covalent bonds.
C205477	PQ/CMC Substance Classification Terminology	C48807	Chemical	A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties.	Chemical		A substance with a defined atomic or molecular structure that results from, or takes part in, reactions involving changes in its structure, composition, or properties.
C205477	PQ/CMC Substance Classification Terminology	C706	Nucleic Acids	Type of substance that may be described as a linear sequence of nucleosides typically linked through phosphate esters.	Nucleic Acids		Type of substance that may be described as a linear sequence of nucleosides typically linked through phosphate esters.
C210149	PQ/CMC State of Matter Terminology	C149895	Semi-solid	A state of matter consisting of molecules in a non-rigid structure that can retain its shape and volume but that is not resistant to such change.	Semi-solid		A state of matter consisting of molecules in a non-rigid structure that can retain its shape and volume but that is not resistant to such change.
C210149	PQ/CMC State of Matter Terminology	C45298	Liquid	A substance in the fluid state of matter having no fixed shape but a fixed volume.	Liquid		A state of matter consisting of molecules in a non-rigid structure that retains its volume but conforms to the shape of any container applying pressure to it, and is subject to flow.
C210149	PQ/CMC State of Matter Terminology	C45299	Gas	A fluid in the gaseous state having neither independent shape nor volume and being able to expand indefinitely.	Gas		A state of matter consisting of molecules in an elastic aeriform fluid, separated from one another and with freedom of movement, no independent shape or volume and the ability to expand indefinitely.
C210149	PQ/CMC State of Matter Terminology	C45300	Solid	The state in which a substance has no tendency to flow under moderate stress; resists forces (such as compression) that tend to deform it; and retains a definite size and shape.	Solid		A state of matter consisting of molecules in a rigid structure that is resistant to change in shape or volume.
C210150	PQ/CMC Basic Solid Dose Form Terminology	C154433	Capsule Dose Form Category	A type of solid pharmaceutical dose form consisting of a shell inside which a single dose of the active substance(s) is enclosed. Cachet is excluded.	Capsule		A type of solid pharmaceutical dose form consisting of a shell inside which a single dose of the active substance(s) is enclosed. Cachet is excluded.
C210150	PQ/CMC Basic Solid Dose Form Terminology	C154605	Tablet Dosage Form Category	A type of solid pharmaceutical dose form consisting of a mass that is formed by compression of uniform volumes of particulate solids, or by other means such as extrusion or moulding.	Tablet		A type of solid pharmaceutical dose form consisting of a mass that is formed by compression of uniform volumes of particulate solids, or by other means such as extrusion or moulding.
C210151	PQ/CMC Basic Liquid Dose Form Terminology	C154598	Solution Dosage Form Category	A type of liquid pharmaceutical dose form consisting of one or more substances dissolved in, or miscible with, an appropriate solvent, forming a single-phase liquid.	Solution		A type of liquid pharmaceutical dose form consisting of one or more substances dissolved in, or miscible with, an appropriate solvent, forming a single-phase liquid.
C211921	PQ/CMC Representation Types Terminology	C103240	Chemical Structure	A representation of the arrangement of atoms and bonds.	Chemical Structure		A representation of the arrangement of atoms and bonds.
C211921	PQ/CMC Representation Types Terminology	C45253	String	An expression consisting of a linear sequence of symbols (characters or words or phrases).	String		An expression consisting of a linear sequence of symbols (characters or words or phrases).
C211921	PQ/CMC Representation Types Terminology	C54273	Picture	A visual representation of an object, scene, person or abstraction.	Picture		A visual representation of an object, scene, person or abstraction.
C211939	PQ/CMC Product Name Type Codes Terminology	C71898	Proprietary Name	The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.	Proprietary Name	Brand	The part of the name or logo associated with a specific product or service identifying and distinguishing it from varieties of the same product or service marketed by competing companies.
C211939	PQ/CMC Product Name Type Codes Terminology	C97054	Generic Name	A non-branded or registered name that meant for common use.	Nonproprietary Name	Common Name || Generic Name	A non-branded or registered name meant for common use.
C54455	SPL Drug Route of Administration Terminology	C128997	Suprachoroidal Route of Administration	Administration above the choroid.			
C54455	SPL Drug Route of Administration Terminology	C132737	Intracanalicular Route of Administration	Administration to, or situated within, a tubular passage or channel of the body.			
C54455	SPL Drug Route of Administration Terminology	C28161	Intramuscular Route of Administration	Intramuscular injection is a route of drug administration via injection into muscle tissue. Aqueous or oleaginous solutions and emulsions or suspensions may be administered. Absorption rates, delay in availability of the drug to the systemic circulation, and duration of effect are perfusion-limited, depend on molecular size of the agent, volume, and osmolarity of the drug solution, fat content of the injection site, and patient physical activity.			
C54455	SPL Drug Route of Administration Terminology	C38192	Auricular Route of Administration	Administration of the drug to or by way of the ear. The drug action is mostly topical/local.			
C54455	SPL Drug Route of Administration Terminology	C38193	Buccal Route of Administration	Administration of a substance through the mucosal membrane on the inside of the cheek or the back of the mouth. Buccal route bypasses first pass metabolism and avoids pre-systemic elimination in the gastrointestinal tract. The buccal environment is well supplied with both vascular and lymphatic drainage and is well suited for a retentive device. This is a feasible alternative for systemic delivery of orally inefficient drugs, such as peptide and protein drug molecules.			
C54455	SPL Drug Route of Administration Terminology	C38194	Conjunctival Route of Administration	Administration of a drug to the conjunctiva, the most frequently used mode of ocular drug delivery. Advantages of this topical route include direct, localized delivery to the target tissue, good accessibility into the intraocular environment owing to membrane permeability and large intercellular spaces, avoidance of hepatic first-pass metabolism, convenience, and relative painlessness. Limitations include rapid drug elimination due to lacrimation and nasolacrimal drainage, drug binding to, and metabolism by, tear proteins, and target non-specificity as a result of systemic absorption through the nasal mucosa and conjunctival vasculature.			
C54455	SPL Drug Route of Administration Terminology	C38197	Dental Route of Administration	Administration of the drug to a tooth or teeth.			
C54455	SPL Drug Route of Administration Terminology	C38198	Soft Tissue Route of Administration	The introduction of a substance into any soft tissue.			
C54455	SPL Drug Route of Administration Terminology	C38200	Administration via Hemodialysis	Method of administering the drug through hemodialysate fluid.			
C54455	SPL Drug Route of Administration Terminology	C38203	Iontophoresis Route of Administration	Ion transfer of topical solution into the epidermis and mucous membranes of body by continuous direct current. Can be used for local and systemic drug delivery. Concept does not refer to ion exchange, air ionization, and phonophoresis.			
C54455	SPL Drug Route of Administration Terminology	C38205	Endocervical Route of Administration	Administration of the drug within the canal of the cervix uteri.			
C54455	SPL Drug Route of Administration Terminology	C38206	Endosinusial Route of Administration	Administration of the drug within the nasal sinuses.			
C54455	SPL Drug Route of Administration Terminology	C38207	Endothoracic Route of Administration	Administration of a drug within the thorax (internal to the ribs).			
C54455	SPL Drug Route of Administration Terminology	C38208	Endotracheal Route of Administration	Endotracheal drug administration involves the introduction of the agent directly through the endotracheal tube in an intubated patient. Generally this route is considered as a last resort for drug administration, and provides a fast, effective means of drug delivery in a patient who requires immediate medication. Plasma levels obtained via endotracheal administration are considerably less than those obtained with an equal dosage administered intravenously or intraosseously. Endotracheal administration must be followed by hyper-insufflation of the lungs to promote optimal drug absorption.			
C54455	SPL Drug Route of Administration Terminology	C38209	Enteral Route of Administration	Administration of a substance by the way of the gastrointestinal tract, usually for systemic action. Drug bioavailability can be affected due to enzymatic degradation by intestinal tissues and microbes, and first-pass hepatic metabolism.			
C54455	SPL Drug Route of Administration Terminology	C38210	Epidural Route of Administration	Administration of the drug in the epidural space, usually at the lumbar level of the spine. The drug must initially cross the dura mater before exerting its effect on the nervous system components. The drug is also subject to uptake into the rich epidural plexus of veins. Uptake and distribution after epidural administration resembles that seen after intramuscular injection. The portion of drug that is not taken into the vascular compartment is available to cross the dura. Hydrophilicity is a major component in the pharmacokinetics of drug transfer into the subdural space.			
C54455	SPL Drug Route of Administration Terminology	C38211	Extraamniotic Route of Administration	Administration of the drug to the outside of the membrane enveloping the fetus.			
C54455	SPL Drug Route of Administration Terminology	C38212	Extracorporeal Circulation Route of Administration	Drug administration outside of the body. Concept refers to a number of techniques and procedures including extracorporeal photopheresis, ultraviolet blood irradiation and extracorporeal detoxification methods with drug administration, etc.			
C54455	SPL Drug Route of Administration Terminology	C38215	Infiltration Route of Administration	Route of drug administration that results in substances passing into tissue spaces or intracellularly.			
C54455	SPL Drug Route of Administration Terminology	C38216	Inhalation Route of Administration	Administration of medication via the respiratory tract, usually by oral or nasal inhalation, for local or systemic effect.			
C54455	SPL Drug Route of Administration Terminology	C38217	Intracoronal Dental Route of Administration	Administration of a drug within a crown of tooth.			
C54455	SPL Drug Route of Administration Terminology	C38218	Intracoronary Route of Administration	Administration of a drug within the coronary arteries supplying blood to the tissues of the heart.			
C54455	SPL Drug Route of Administration Terminology	C38219	Interstitial Route of Administration	Drug administration to or in the interstices of a tissue.			
C54455	SPL Drug Route of Administration Terminology	C38220	Intraabdominal Route of Administration	Administration of the drug within the abdominal cavity, typically as a loco-regional therapy for disease confined to the abdomen.			
C54455	SPL Drug Route of Administration Terminology	C38221	Intraamniotic Route of Administration	Administration of the drug within the amnion.			
C54455	SPL Drug Route of Administration Terminology	C38222	Intraarterial Route of Administration	The administration of a substance directly into an artery.			
C54455	SPL Drug Route of Administration Terminology	C38223	Intraarticular Route of Administration	Administration of the drug within a joint.			
C54455	SPL Drug Route of Administration Terminology	C38224	Intrabiliary Route of Administration	Administration within the biliary system for selective delivery of the agent to targeted hepatobiliary tissues and cell types, the goal of which is utilization of optimal therapeutic dosages combined with a reduction in systemic toxicity. Strategies for improving the tissue specificity include the use of tissue-specific ligands and the focal administration of drugs. Focal delivery has been primarily directed at uptake by the hepatocyte basolateral membrane and has included direct intraparenchymal injection, portal venous infusion, hepatic arterial infusion, and surgical systems for temporarily isolating the liver from the vasculature.			
C54455	SPL Drug Route of Administration Terminology	C38225	Intrabronchial Route of Administration	Administration of a drug within a bronchus or bronchi. The intrabronchial drug delivery can be used for both local and systemic drug action.			
C54455	SPL Drug Route of Administration Terminology	C38226	Intrabursal Route of Administration	Administration of a drug within a bursal cavity.			
C54455	SPL Drug Route of Administration Terminology	C38227	Intracardiac Route of Administration	Administration of a drug within the heart.			
C54455	SPL Drug Route of Administration Terminology	C38228	Intracartilaginous Route of Administration	Administration of a drug within a cartilage.			
C54455	SPL Drug Route of Administration Terminology	C38229	Intracaudal Route of Administration	Administration of a drug within the cauda equina.			
C54455	SPL Drug Route of Administration Terminology	C38230	Intracavernous Route of Administration	Administration of a drug within a pathologic cavity.			
C54455	SPL Drug Route of Administration Terminology	C38231	Intracavitary Route of Administration	Administration of medication within any natural, non-pathologic cavity, such as that of cervix, uterus, or penis.			
C54455	SPL Drug Route of Administration Terminology	C38232	Intracerebral Route of Administration	Administration of a drug within the cerebrum, directly into brain tissue, usually by injection or direct application.			
C54455	SPL Drug Route of Administration Terminology	C38233	Intracisternal Route of Administration	Administration of a drug directly into the cerebrospinal fluid of the brain ventricles. It could be performed by direct injection into the cisterna magna or via permanently positioned tube.			
C54455	SPL Drug Route of Administration Terminology	C38234	Intracorneal Route of Administration	Administration of a drug within the eye cornea.			
C54455	SPL Drug Route of Administration Terminology	C38235	Intracorpus Cavernosum Route of Administration	Administration of medication within the dilatable venous spaces of the cavernous tissue of the penis.			
C54455	SPL Drug Route of Administration Terminology	C38236	Intracranial Route of Administration	Administration of a drug within the skull.			
C54455	SPL Drug Route of Administration Terminology	C38238	Intradermal Route of Administration	Intradermal injection is a method of drug administration within the substance of the skin, particularly the dermis.			
C54455	SPL Drug Route of Administration Terminology	C38239	Intradiscal Route of Administration	Administration of a drug within a fibrocartilaginous intervertebral disc.			
C54455	SPL Drug Route of Administration Terminology	C38240	Intraductal Route of Administration	Administration of a drug within the duct of a gland.			
C54455	SPL Drug Route of Administration Terminology	C38241	Intraduodenal Route of Administration	Administration of a drug within the duodenum.			
C54455	SPL Drug Route of Administration Terminology	C38242	Intradural Route of Administration	Administration of a drug within or beneath the dura mater.			
C54455	SPL Drug Route of Administration Terminology	C38243	Intraepidermal Route of Administration	Administration of a drug within the superficial epithelial layer of the skin.			
C54455	SPL Drug Route of Administration Terminology	C38245	Intraesophageal Route of Administration	Administration of a drug within the esophagus.			
C54455	SPL Drug Route of Administration Terminology	C38246	Intragastric Route of Administration	Administration of a drug within the stomach, e.g. via gavage or via gastrostomy.			
C54455	SPL Drug Route of Administration Terminology	C38247	Intragingival Route of Administration	Administration of a drug within the gingivae.			
C54455	SPL Drug Route of Administration Terminology	C38248	Intrahepatic Route of Administration	Intrahepatic route of drug administration is a method of drug delivery within the liver, predominantly via hepatic vein or artery. Regimen might be more beneficial then systemic one by delivering a higher dose of drug to the liver and reducing overall systemic exposure.			
C54455	SPL Drug Route of Administration Terminology	C38249	Intraileal Route of Administration	Administration of a drug within the distal portion of the small intestine, from the jejunum to the cecum.			
C54455	SPL Drug Route of Administration Terminology	C38250	Intralesional Route of Administration	Administration of a drug within or introduced directly into a localized lesion. Method allows to achieve high concentration of the agent in the lesion and delay drug release in systemic circulation.			
C54455	SPL Drug Route of Administration Terminology	C38251	Intraluminal Route of Administration	Administration of a drug within the cavity or channel of a tubular structure or tubular organ.			
C54455	SPL Drug Route of Administration Terminology	C38252	Intralymphatic Route of Administration	Administration of a drug within the lymphatic system: into the lymph nodes or/and the lymph vessels.			
C54455	SPL Drug Route of Administration Terminology	C38253	Intramedullary Route of Administration	Administration of a drug within the marrow cavity of a bone. The essential premise for intraosseous administration is a functioning medullary cavity. The route is considered reasonably safe and permits rapid achievement of satisfactory plasma concentrations of therapeutic agent. The route is used for blood transfusion or fluid therapy when other routes are awkward, as in neonates.			
C54455	SPL Drug Route of Administration Terminology	C38254	Intrameningeal Route of Administration	The administration of a drug within meningeal membranes.			
C54455	SPL Drug Route of Administration Terminology	C38255	Intraocular Route of Administration	Administration of a drug within the eye. Intraocular drugs are almost always used for their local effects.			
C54455	SPL Drug Route of Administration Terminology	C38256	Intraovarian Route of Administration	Administration of a drug within the ovary or ovaries.			
C54455	SPL Drug Route of Administration Terminology	C38257	Intrapericardial Route of Administration	Administration of a drug within the pericardium. Intrapericardial application of therapeutic agents provides a strategy for site-specific treatment of heart or coronary diseases. The magnitude of the local advantage depends on substance exchange between the local and the blood compartments and on substance elimination from these compartments.			
C54455	SPL Drug Route of Administration Terminology	C38258	Intraperitoneal Route of Administration	Administration of a drug via injection or infusion of a substance into the peritoneum, where it is absorbed by the lining.			
C54455	SPL Drug Route of Administration Terminology	C38259	Intrapleural Route of Administration	Administration of a drug within the pleural cavity. The intrapleural drug administration usually results in both local and systemic drug action.			
C54455	SPL Drug Route of Administration Terminology	C38260	Intraprostatic Route of Administration	Administration of a drug within the prostate gland.			
C54455	SPL Drug Route of Administration Terminology	C38261	Intrapulmonary Route of Administration	Administration of a substance in the form gas, aerosol, emulsion, or liquid (during partial and tidal liquid ventilation), or fine powder into the lung, often with systemic action. Method limitations: insufficient drug delivery to peripheral lung regions, the inability to quantify the actually administered dose, and non-homogeneous distribution.			
C54455	SPL Drug Route of Administration Terminology	C38262	Intrasinal Route of Administration	The administration of a drug through the nasal sinuses.			
C54455	SPL Drug Route of Administration Terminology	C38263	Intraspinal Route of Administration	The administration of a drug within the vertebral column. High therapeutic ratio is based on drug delivery directly to central nervous system sites of action.			
C54455	SPL Drug Route of Administration Terminology	C38264	Intrasynovial Route of Administration	The administration of a drug within the synovial cavity of a joint.			
C54455	SPL Drug Route of Administration Terminology	C38265	Intratendinous Route of Administration	The administration of an agent within a tendon. The route is used for local therapy in various conditions of the tendinous or bursal structures such as tendinitis, tenosynovitis, epicondylitis, etc. Depending on indications and the drug, injection could be done into the tendon sheath or into the substance of the tendon.			
C54455	SPL Drug Route of Administration Terminology	C38266	Intratesticular Route of Administration	The administration of a drug within the testicle.			
C54455	SPL Drug Route of Administration Terminology	C38267	Intrathecal Route of Administration	Administration of drugs directly into spinal subarachnoid space in the cerebrospinal fluid, at any level of the cerebrospinal axis, including injection into the cerebral ventricles, in order to bypass the blood-brain barrier and achieve local, rapid effects on the meninges or cerebrospinal axis.			
C54455	SPL Drug Route of Administration Terminology	C38268	Intratubular Route of Administration	The administration of a drug within the tubules of an organ.			
C54455	SPL Drug Route of Administration Terminology	C38269	Intratumoral Route of Administration	The administration of a drug within or introduced directly into a tumor. Method allows to achieve high concentration of the agent in the tumor and delay drug release in systemic circulation.			
C54455	SPL Drug Route of Administration Terminology	C38270	Intratympanic Route of Administration	The administration of a drug directly into the tympanic cavity has high safety profile and allows delivering high concentrations of the agent to the inner ear end organ. Perfusion is performed under the surgical microscope by inserting the needle in the posterior-inferior aspect of the tympanic membrane.			
C54455	SPL Drug Route of Administration Terminology	C38271	Intraurethral Route of Administration	Administration of a drug directly into the urethra.			
C54455	SPL Drug Route of Administration Terminology	C38272	Intrauterine Route of Administration	The administration of a drug within the uterus.			
C54455	SPL Drug Route of Administration Terminology	C38273	Intravascular Route of Administration	The administration of an agent within a vessel or vessels.			
C54455	SPL Drug Route of Administration Terminology	C38274	Intravenous Bolus	A volume of drug intended to be administered into a vein at a relatively fast rate. The volume of drug and the rate of administration are specified.			
C54455	SPL Drug Route of Administration Terminology	C38276	Intravenous Route of Administration	Administration of a drug within or into a vein or veins. Introduction of the drug directly into venous circulation results in 100% bioavailability due to an absence of the absorption phase, provides a precise and continuous mode of drug therapy, especially for drugs with a narrow therapeutic index.			
C54455	SPL Drug Route of Administration Terminology	C38277	Intraventricular Route of Administration	Administration of a drug directly into a cerebral ventricle, commonly using a reservoir. This allows a more even distribution of drug through the cerebrospinal fluid (CSF) and is particularly useful in the treatment of certain types of cancers.			
C54455	SPL Drug Route of Administration Terminology	C38278	Intravesical Route of Administration	The administration of a drug within the urinary bladder.			
C54455	SPL Drug Route of Administration Terminology	C38279	Intravenous Drip	The administration of a drug within or into a vein or veins over a sustained period of time. A slow, continuous drip avoids excessively high transient peak plasma levels.			
C54455	SPL Drug Route of Administration Terminology	C38280	Intravitreal Route of Administration	The administration of a drug within the vitreous body of the eye.			
C54455	SPL Drug Route of Administration Terminology	C38281	Irrigation Route of Administration	Administration of a drug by bathing or flushing open wounds, body cavities or surfaces.			
C54455	SPL Drug Route of Administration Terminology	C38282	Laryngeal Route of Administration	Administration of a drug directly upon the larynx.			
C54455	SPL Drug Route of Administration Terminology	C38283	Mucosal Route of Administration	Administration of a substance to the mucosa; often resulting in systemic action due to absorption.			
C54455	SPL Drug Route of Administration Terminology	C38284	Nasal Route of Administration	Administration of a drug by the way of the nose. This often results in systemic action of the agent due to absorption through the nasal mucosa. The richly supplied vascular nature of the nasal mucosa coupled with its high drug permeation makes the nasal route of administration attractive for many drugs, including proteins and peptides.			
C54455	SPL Drug Route of Administration Terminology	C38285	Nasogastric Route of Administration	Administration of a drug through the nose and into the stomach, usually by means of a tube.			
C54455	SPL Drug Route of Administration Terminology	C38286	Occlusive Dressing Technique	Administration of a substance by the topical route that is then covered by a dressing which occludes the area of drug application.			
C54455	SPL Drug Route of Administration Terminology	C38287	Ophthalmic Route of Administration	Administration of medication to the external surfaces of the eye.			
C54455	SPL Drug Route of Administration Terminology	C38288	Oral Route of Administration	The introduction of a substance to the mouth or into the gastrointestinal tract by the way of the mouth, usually for systemic action. It is the most common, convenient, and usually the safest and least expensive route of drug administration, but it uses the most complicated pathway to the tissues and bioavailability varies. The disadvantages of method are hepatic first pass metabolism and enzymatic degradation of the drug within the gastrointestinal tract. This prohibits oral administration of certain classes of drugs especially peptides and proteins.			
C54455	SPL Drug Route of Administration Terminology	C38289	Oropharyngeal Route of Administration	Administration of a drug directly to the mouth and pharynx.			
C54455	SPL Drug Route of Administration Terminology	C38290	Other Route of Administration	Route of drug administration not specified on this list.			
C54455	SPL Drug Route of Administration Terminology	C38291	Parenteral Route of Administration	Administration of a substance by some means other than through the gastrointestinal tract: usually through injection, infusion, or implantation. Predominantly, the drug action is systemic, but in some cases, it is confined to local area.			
C54455	SPL Drug Route of Administration Terminology	C38292	Periarticular Route of Administration	Administration of a substance within the tissues surrounding a joint.			
C54455	SPL Drug Route of Administration Terminology	C38293	Perineural Route of Administration	Administration of a substance within the tissues surrounding a nerve or nerves.			
C54455	SPL Drug Route of Administration Terminology	C38294	Periodontal Route of Administration	Administration of a substance within the tissues surrounding a tooth or teeth.			
C54455	SPL Drug Route of Administration Terminology	C38295	Rectal Route of Administration	The introduction of a substance into the gastrointestinal tract by the way of the rectum, usually for systemic action. Depending on the molecular structure, drugs cross the rectal wall via either intercellular or tight junctions interconnecting the mucosal cells. Drug absorption is usually around 50% of normal oral dose. Due to the drainage pattern of the rectal veins, the hepatic first-pass effect tends to increase as the dosage form is placed deeper into the rectum. Solid suppositories represent greater than 98% of all rectal dosage forms.			
C54455	SPL Drug Route of Administration Terminology	C38296	Retrobulbar Route of Administration	The introduction of a substance behind the pons or behind the eyeball.			
C54455	SPL Drug Route of Administration Terminology	C38297	Subarachnoid Route of Administration	The introduction of a substance beneath the arachnoidal membrane			
C54455	SPL Drug Route of Administration Terminology	C38298	Subconjunctival Route of Administration	The introduction of a substance beneath the conjunctiva.			
C54455	SPL Drug Route of Administration Terminology	C38299	Subcutaneous Route of Administration	Drug administration beneath the skin. It provides for relatively slow, sustained release of the drug. The rate of absorption into the blood is perfusion-limited, proportional to the amount of drug at the site and can be enhanced by chemical or physical stimulation of blood flow. Subcutaneous administration minimizes the risks associated with intravascular injection: for subcutaneous infusions, external and implantable pumps are used.			
C54455	SPL Drug Route of Administration Terminology	C38300	Sublingual Route of Administration	Administration of a drug beneath the tongue. The route provides rapid absorption, the drug immediately enters the bloodstream without first passing through the intestinal wall and liver. However, most drugs cannot be taken this way because they may be absorbed incompletely or erratically.			
C54455	SPL Drug Route of Administration Terminology	C38301	Submucosal Route of Administration	Administration of a drug beneath the mucous membrane.			
C54455	SPL Drug Route of Administration Terminology	C38304	Topical Route of Administration	The application of a drug to a certain area of the skin or mucous membrane (including the intra-organ application), or other tissue locally, so that the agent will take effect on the surface and/or on the underlying tissues.			
C54455	SPL Drug Route of Administration Terminology	C38305	Transdermal Route of Administration	Administration of a substance through the dermal layer of the skin into the systemic circulation by diffusion.			
C54455	SPL Drug Route of Administration Terminology	C38307	Transplacental Route of Administration	Administration of a drug to an embryo in utero via systemic administration of the substance to the pregnant mother. Drugs cross the placenta through passive diffusion, active transport, pinocytosis and filtration. The properties of drugs that determine placental transfer by passive diffusion include molecular weight, pKa, lipid solubility and protein binding. Drugs with molecular weight of over 500 D are transferred incompletely. Drug metabolism and uptake can be altered by placental enzymes.			
C54455	SPL Drug Route of Administration Terminology	C38308	Transtracheal Route of Administration	Administration of a drug through the wall of the trachea.			
C54455	SPL Drug Route of Administration Terminology	C38309	Transtympanic Route of Administration	Administration of a drug across or through the tympanic cavity. This method reduces the total dose of medication, and allows high concentrations of drug to be delivered directly to the target tissue, while reducing systemic effects. Transtympanic medication can be administered through a needle puncture of the eardrum. If multiple injections are required, a myringotomy tube can be inserted.			
C54455	SPL Drug Route of Administration Terminology	C38310	Unassigned Route of Administration	Route of administration has not yet been assigned.			
C54455	SPL Drug Route of Administration Terminology	C38311	Unknown Route of Administration	The route of drug administration is unknown.			
C54455	SPL Drug Route of Administration Terminology	C38312	Ureteral Route of Administration	Administration of a drug into the ureter.			
C54455	SPL Drug Route of Administration Terminology	C38313	Vaginal Route of Administration	Administration of a drug into the vagina. The medication usually has the form of a solution, tablet, cream, gel, or suppository. The drug is slowly absorbed through the vaginal wall with predominantly local, but some systemic effects.			
C54455	SPL Drug Route of Administration Terminology	C38633	Electro-osmosis Route of Administration	Administration of drug by way of diffusion, through a membrane in an electric field. Electro-osmosis describes the active transport of non-ionized solutes associated with the bulk flow of fluid in the direction of the counter-ions that occurs with iontophoretic transport of other, ionized solutes. Using this method, even a neutral compound can be administered. Method can be used for local and systemic drug delivery.			
C54455	SPL Drug Route of Administration Terminology	C38675	Cutaneous Route of Administration	Administration to the skin.			
C54455	SPL Drug Route of Administration Terminology	C38676	Percutaneous Route of Administration	Administration of a drug by the way of absorption through the skin, usually for systemic action. The route allows sustained therapeutic plasma drug levels and avoids first pass effect. Simplicity of administration tends to result in high patient compliance.			
C54455	SPL Drug Route of Administration Terminology	C38677	Peridural Route of Administration	The administration of a drug via injection or infusion into the epidural space, the area immediately adjacent to the outside surface of the dura mater of the spinal cord.			
C54455	SPL Drug Route of Administration Terminology	C48623	Route of Administration Not Applicable	The route of drug administration is not applicable.			
C54455	SPL Drug Route of Administration Terminology	C65103	Subgingival Route of Administration	Administration of a drug beneath the gingival surface.			
C54455	SPL Drug Route of Administration Terminology	C79137	Intramammary Route of Administration	Administration of a drug into mammary tissue.			
C54455	SPL Drug Route of Administration Terminology	C79138	Intralingual Route of Administration	Administration of a drug into the tongue.			
C54455	SPL Drug Route of Administration Terminology	C79139	Intraruminal Route of Administration	Administration of a drug into the rumen of an animal.			
C54455	SPL Drug Route of Administration Terminology	C79141	Intranodal Route of Administration	Administration within a lymph node.			
C54455	SPL Drug Route of Administration Terminology	C79142	Intraomentum Route of Administration	Administration within the fold of peritoneum connecting or supporting abdominal structures.			
C54455	SPL Drug Route of Administration Terminology	C79143	Subretinal Route of Administration	Administration beneath the retina.			
C54455	SPL Drug Route of Administration Terminology	C79144	Intraepicardial Route of Administration	Administration to the epicardial space or through the epicardium to deliver the product to the myocardium.			
C54455	SPL Drug Route of Administration Terminology	C79145	Transendocardial Route of Administration	Administration through endocardium to deliver the product to myocardium.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C100103	Cellular Sheet Dosage Form	A skin graft sheet composed of viable cells layered on a supporting substrate.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C113106	Injectable Foam Dosage Form	A foam intended for parenteral administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C124794	Extended Release Chewable Tablet Dosage Form	A tablet that must be chewed in order to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C134876	Chewable Gel Dosage Form	A formed or molded oral gel dosage form that maintains its shape, is elastic, and yields to mastication.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C147579	Tablet with Sensor Dosage Form	A solid dosage form containing medicinal substances, with or without suitable diluents, plus an ingestible sensor that communicates with medical devices that are usually located outside of the body.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C17423	Drug Delivery System	Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C185352	Drug-eluting Contact Lens Dosage Form	A corrective, cosmetic, or therapeutic lens placed on the cornea of the eye that elutes medication.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C25158	Capsule Dosage Form	A solid contained within either a hard or soft soluble shell, usually prepared from gelatin.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C25394	Pill Dosage Form	A solid composed of a small, round object composed of active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C28944	Cream Dosage Form	A semi-solid composed of an emulsion of lipids, hydrocarbons, waxes, or polyols in water.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C29167	Lotion Dosage Form	A semi-solid composed of an oil in water emulsion, with lower viscosity than cream or gel.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C29269	Mouthwash Dosage Form	A solution or suspension intended for oral administration, for its deodorizing or antiseptic effects in the oral cavity. Usually, the mouthwash is swished around the mouth and expelled.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42679	Douche Dosage Form	A substance intended for use as a vaginal irrigant.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42763	Dressing Dosage Form	A substance intended for administration in or on a wound.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42887	Aerosol Dosage Form	Contents packaged under pressure that are released upon activation of an appropriate valve system.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42888	Aerosol Foam Dosage Form	A foam that is packaged under pressure and released upon activation of an appropriate valve system.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42889	Aerosol Spray Dosage Form	A spray that is packaged under pressure and released upon activation of an appropriate valve system.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42890	Bead Dosage Form	A solid in the shape of a small sphere.	Bead		A constituent composed of small sphere(s).
C54456	SPL Pharmaceutical Dosage Form Terminology	C42892	Chewable Bar Dosage Form	A bar designed to be chewed to release active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42893	Chewable Tablet Dosage Form	A tablet that must be chewed to release the active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42894	Chewing Gum Dosage Form	A semi-solid composed of synthetic, polymerized polysaccharide and flavorings, intended to be chewed to release active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42895	Coated Capsule Dosage Form	A capsule that contains an additional outer layer over the capsule shell.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42896	Coated Pellet in Capsule Dosage Form	A capsule composed of small globular masses covered with an outer shell.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42897	Coated Tablet Dosage Form	A tablet whose outer shell is covered with a substance.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42898	Concentrated Solution Dosage Form	A concentrate which is usually diluted prior to administration and exists as a solution in its final form.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42899	Concentrated Injectable Solution Dosage Form	A concentrate which is usually diluted prior to administration by injection.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42901	Crystal Dosage Form	A solid that consists of naturally produced angular solids composed of singular, repeating units that are systematically arranged in an evenly spaced lattice.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42902	Delayed Release Capsule Dosage Form	A capsule covered with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42903	Delayed Release Granules Dosage Form	A solid composed of small particles or grains and have been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42904	Delayed Release Pellet in Capsule Dosage Form	A capsule composed of active and/or inert ingredient(s) small, spherical structures that have been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42905	Delayed Release Tablet Dosage Form	A tablet that has been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42906	Dentifrice Gel Dosage Form	A gel intended for use in the oral cavity to clean the teeth and maintain oral hygiene.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42907	Dentifrice Paste Dosage Form	A paste of mild abrasives, detergents, flavoring agents, binders, fluoride, and other active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42908	Dentifrice Powder Dosage Form	A powder composed of a mild abrasives, detergents, flavoring agents, binders, fluoride, and other active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42909	Effervescent Granules Dosage Form	A granule composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbon dioxide when dissolved in water.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42910	Effervescent Tablet Dosage Form	A tablet composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbon dioxide when dissolved in water.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42911	Electrically Controlled Extended Release Patch Dosage Form	A patch that composed of active and/or inert ingredient(s) whose release is controlled by electronic impulses that release ingredients at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42912	Elixir Dosage Form	A solution composed of a clear, sweetened hydroalcoholic liquid in which active and/or inert ingredient(s) are dissolved.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42913	Emulsion Dosage Form	A semi-solid composed of at least two immiscible liquids, one of which is dispersed as droplets within the other liquid, and stabilized with one or more emulsifying agents.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42914	Emulsion for Injection Dosage Form	An emulsion intended for injection.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42915	Enema Dosage Form	A solution or suspension intended for administration into the rectum.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42916	Extended Release Capsule Dosage Form	A capsule designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42917	Extended Release Coated Capsule Dosage Form	A capsule covered with a thin layer of substance and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42918	Extended Release Coated Pellet Dosage Form	A pellet covered with a thin layer of substance that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42920	Extended Release Film Dosage Form	A film that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42921	Extended Release Granule for Suspension Dosage Form	A granule intended for administration as a suspension and designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42922	Extended Release Insert Dosage Form	An insert designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42923	Extended Release Patch Dosage Form	A patch designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42924	Extended Release Suppository Dosage Form	A suppository that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42925	Extended Release Suspension Dosage Form	A suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42926	Injectable Extended Release Suspension Dosage Form	A suspension intended for injection that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42927	Extended Release Tablet Dosage Form	A tablet designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42928	Extended Release Film Coated Capsule Dosage Form	A capsule covered with a thin layer of water soluble or insoluble polymer and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42929	Extract Dosage Form	A distillate composed of active and/or inert ingredient(s) extracted from plant or animal matter, and represented in concentrated form.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42930	Film Coated Extended Release Tablet Dosage Form	A tablet covered with a thin layer of water soluble or insoluble polymer and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42931	Film Coated Tablet Dosage Form	A tablet covered with a thin layer of water soluble or insoluble polymer.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42932	Film Dosage Form	A thin layer of water soluble or insoluble polymer intended to coat the site of administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42933	Gas Dosage Form	An elastic aeriform fluid in which the molecules are separated from one another and have freedom of movement.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42934	Gel Dosage Form	A semi-solid composed of a solid, three dimensional, cross linked matrix of polymers within a liquid, yielding a jelly-like material unable to flow at steady state.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42935	Extended Release Gel Forming Solution Dosage Form	A solution that becomes gelatinous upon administration and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42936	Gelatin Coated Capsule Dosage Form	A capsule covered with a thin layer of gelatin.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42937	Globule Dosage Form	A solid composed of sucrose, lactose or other polysaccharides formed into small globular pellets impregnated with active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42938	Granule Dosage Form	A solid composed of small particles or grains.	Granules		A constituent composed of dry aggregates of powder particles that may contain one or more APIs, with or without other ingredients.
C54456	SPL Pharmaceutical Dosage Form Terminology	C42939	Granule for Solution Dosage Form	A granule intended for administration as a solution.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42940	Granule for Suspension Dosage Form	A granule intended for administration as a suspension.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42942	Implant Dosage Form	A solid intended for insertion securely within the body.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42943	Implantable Pellet Dosage Form	A pellet intended for insertion securely within the body.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42944	Inhalant Dosage Form	Vaporized active and/or inert ingredient(s) intended for administration by inhalation.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42945	Injectable Solution Dosage Form	A solution intended for injection.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42946	Injectable Dosage Form	A substance intended for injection.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42947	Irrigant Dosage Form	A solution or suspension used to bathe or flush open wounds or body cavities.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42948	Jelly Dosage Form	A semi-solid composed of suspensions of active and/or inert ingredient(s) in any type of highly viscous material, including gelatin or gel. The structural matrix of the jelly contains high levels of liquid.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42949	Liniment Dosage Form	A semi-solid with viscosity similar to that of a lotion, which is intended for topical use and must be rubbed into the site of administration to release the active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42950	Injectable Lipid Complex Dosage Form	A substance composed of complexed active and/or inert ingredient(s) with natural or synthetic lipids that is intended for injection.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42951	Injectable Liposomal Suspension Dosage Form	A suspension composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42952	Lipstick Dosage Form	A solid or semi-solid with a waxy consistency in the shape of a stick and intended for use on the lips.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42953	Liquid Dosage Form	A substance in the fluid state of matter having no fixed shape but a fixed volume.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42954	Liquid Filled Capsule Dosage Form	A capsule composed of liquid covered with an outer shell, which is usually prepared from gelatin.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42955	Lozenge Dosage Form	A solid composed of active and/or inert ingredient(s), sweeteners, other flavorings and mucilage, intended for oral administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42956	Lyophilized Powder for Extended Release Injectable Suspension Dosage Form	A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42957	Lyophilized Powder for Injectable Solution Dosage Form	A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a solution.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42958	Lyophilized Powder for Injectable Suspension Dosage Form	A freeze dried powder intended for injection following reconstitution with a suitable solvent to form a suspension.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42959	Lyophilized Powder for Injectable Liposomal Suspension Dosage Form	A freeze dried powder composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection following reconstitution with a suitable solvent to form a suspension.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42960	Metered Aerosol Dosage Form	An aerosol contained in a device with valves that permits the release of a specified quantity of active and/or inert ingredient(s) upon activation.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42961	Metered Powder Dosage Form	A powder contained in a device with valves that permits the dispensing of active and/or inert ingredient(s) upon activation.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42962	Metered Spray Dosage Form	A spray contained in a device with valves that permits the dispensing of a specified quantity of active and/or inert ingredient(s) upon activation.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42963	Multilayered Extended Release Tablet Dosage Form	A tablet composed of active and/or inert ingredient(s) that have been compressed into multiple layers and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42964	Multilayered Tablet Dosage Form	A tablet composed of active and/or inert ingredient(s) that have been compressed to form a tablet that contains multiple layers.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42965	Oil Dosage Form	A solution or suspension that is hydrophobic, soluble in organic solvents, and liquid at ambient temperature.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42966	Ointment Dosage Form	A semi-solid, viscous in texture, that may be composed of a variety of bases including hydrocarbons, emulsifiers or vegetable oils, and mixed with active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42967	Paste Dosage Form	A semi-solid composed of a large proportion of solids and finely dispersed active and/or inert ingredient(s) in a fat-based vehicle.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42968	Patch Dosage Form	A solid composed of an impermeable occlusive backing and a formulation matrix in which the active and/or inert ingredient(s) are dissolved or dispersed; possibly includes an adhesive layer.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42969	Pellet Dosage Form	A solid composed of a small granular or compressed mass that contains highly purified active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42970	Plaster Dosage Form	A semi-solid composed of a soft, smooth mass with relatively thick consistency and strong adhesiveness that becomes solid when dry.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42971	Powder Aerosol Dosage Form	A powder composed of active and/or inert ingredient(s) and packaged under pressure. Ingredients are released upon activation of an appropriate valve system.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42972	Powder Dosage Form	A solid composed of a mixture of dry, finely divided active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42973	Powder for Solution Dosage Form	A powder that yields a solution following reconstitution with an appropriate liquid.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42974	Powder for Injectable Solution Dosage Form	A powder intended for injection following reconstitution to form a solution.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42975	Powder for Suspension Dosage Form	A powder that forms a suspension when reconstituted with a liquid solution.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42976	Powder for Injectable Suspension Dosage Form	A powder intended for injection following reconstitution to form a suspension.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42977	Powder for Injectable Extended Release Suspension Dosage Form	A powder intended for injection following reconstitution to form a suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42979	Rinse Dosage Form	A solution or suspension intended for irrigation purposes.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42980	Salve Dosage Form	A semi-solid composed of a thick, fat or wax-based ointment or cerate with a consistency somewhere between an ointment and a plaster.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42981	Shampoo Dosage Form	A solution or suspension composed of an anionic surfactant and intended for administration to the hair and/or scalp.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42982	Shampoo Suspension Dosage Form	A suspension composed of anionic surfactant and intended for administration to the hair and/or scalp.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42983	Soap Dosage Form	An anionic surfactant for cleansing.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42984	Soluble Film Dosage Form	A film that will dissolve in a liquid solvent to form a solution.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42985	Soluble Tablet Dosage Form	A tablet that will dissolve in a liquid solvent to form a solution.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42986	Solution Dosage Form	A clear, homogeneous liquid composed of one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.	Solution		A constituent that is a clear, homogeneous liquid containing one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
C54456	SPL Pharmaceutical Dosage Form Terminology	C42987	Solution for Slush Dosage Form	A solution composed of an iced saline slurry with or without active and/or inert ingredient(s) intended to induce regional hypothermia from the point of administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42988	Injectable Sonicated Suspension Dosage Form	A suspension intended for injection and is sonicated while a gas is bubbled through the suspension resulting in the creation of microspheres by the solid particles.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42989	Spray Dosage Form	A solution or suspension composed of active and/or inert ingredient(s) in oil or water, typically dispensed from an atomizer or nebulizer.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42990	Spray Suspension Dosage Form	A spray composed of a suspension that contains active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42991	Stick Dosage Form	A solid composed active and/or inert ingredient(s) in a long, slender cylindrical shape.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42992	Sugar Coated Tablet Dosage Form	A tablet covered with sugar.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42993	Suppository Dosage Form	A solid or semi-solid composed of active and/or inert ingredient(s) in a wax, fat or a glycerin gelatin jelly and that is conical or oval in shape. It is intended to be inserted into a body orifice.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42994	Suspension Dosage Form	Insoluble solid particles composed of active and/or inert ingredient(s) that are dispersed in a liquid.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42995	Injectable Suspension Dosage Form	A suspension intended for injection.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42996	Syrup Dosage Form	A solution or suspension composed of a viscid vehicle that contains a high concentration of sucrose or other sugars and active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42997	Delayed Release Particle Tablet Dosage Form	A tablet composed of individual fragments have been coated with a substance that is designed to impede the immediate release of the active and/or inert ingredient(s) after administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C42998	Tablet Dosage Form	A solid composed of a mixture of that active and/or inert ingredient(s) are pressed or compacted together, usually in the form of a relatively flat and round, square or oval shape.	Tablet		A constituent prepared from powders or granules by compaction (with or without API and/or excipients). The tablet may be coated or uncoated.
C54456	SPL Pharmaceutical Dosage Form Terminology	C42999	Orally Disintegrating Tablet Dosage Form	A tablet which disintegrates and dissolves quickly (usually within a matter of seconds) in the mouth. Additional water to complete dissolution is not necessary.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C43000	Tincture Dosage Form	A solution composed of an alcoholic extract or solution of nonvolatile active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C43001	Troche Dosage Form	A solid discoid composed of active and/or inert ingredient(s) in a suitably flavored base, that dissolves when sucked in the mouth.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C43003	Wafer Dosage Form	A solid composed of a thin slice of material that contain active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C43525	Disc Dosage Form	A flat, circular shaped form composed of a solid or powder that contains active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C47892	Tampon Dosage Form	A solid composed of a plug made from absorbent material.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C47897	Tape Dosage Form	A solid composed of narrow woven fabric or a narrow extruded synthetic material, usually with an adhesive on one or both sides.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C47898	Swab Dosage Form	A solid composed of a small piece of absorbent material attached to one end of a small stick.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C47912	Sponge Dosage Form	A solid composed of a porous, interlacing, absorbent, usually shape retaining material, such as cellulose wood fibers or plastic polymer form.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C47913	Poultice Dosage Form	A semi-solid composed of a soft, moist mass that is made by wetting an absorbent solid substance.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C47914	Strip Dosage Form	A solid composed of active and/or inert ingredient(s) in a long narrow piece of material.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C47915	Intrauterine Device Dosage Form	A solid intended for placement within the uterine cavity where active and/or inert ingredient(s) are released from an apparatus at a controlled rate.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C47916	Kit Dosage Form	A collection of materials that are used together to orchestrate dosage administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C48624	Dosage Form Not Applicable	An indication that the dosage form is not relevant or appropriate.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60884	Cloth Dosage Form	A solid composed active and/or inert ingredient(s) in a woven absorbent material.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60891	Concentrated Dosage Form	A solution or suspension composed of active and/or inert ingredient(s) with increased strength in a reduced volume, which is usually diluted prior to administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60897	Augmented Cream Dosage Form	A cream that is modified to enhance the release of active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60926	Extended Release Fiber Dosage Form	A solid in the shape of a slender, elongated thread that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60927	Dosage Form for Solution	A substance intended for administration as a solution.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60928	Dosage Form for Suspension	A substance intended for administration as a suspension.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60929	Extended Release Dosage Form for Suspension	A substance that forms a suspension upon reconstitution and designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60930	Metered Gel Dosage Form	A gel contained in a device with valves that permits the release of a uniform dose of gel that composed of active and/or inert ingredient(s) upon activation.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60931	Liposomal Injection Dosage Form	A substance composed of active and/or inert ingredient(s) encapsulated in liposomes and intended for injection.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60933	Insert Dosage Form	A solid or semi-solid intended for administration within the body.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60934	Extended Release Liquid Dosage Form	A solution or suspension that is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60957	Augmented Lotion Dosage Form	A lotion that is modified to enhance the release of active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60958	Lotion Shampoo Dosage Form	A lotion composed of anionic surfactant intended for administration to the hair or scalp.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60984	Augmented Ointment Dosage Form	An ointment that is modified to enhance the release of active and/or inert ingredient(s).			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60985	Pastille Dosage Form	A solid or semi-solid composed of a lozenge, that contains active and/or inert ingredient(s) that dissolves when sucked in the mouth.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60988	Ring Dosage Form	A solid composed active and/or inert ingredient(s) of in the shape of a hoop.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60992	Drop Solution Dosage Form	A solution intended for administration in a drop-wise fashion.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60994	Gel Forming Drop Solution Dosage Form	A solution intended for administration in a drop-wise fashion; it becomes gelatinous upon administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60995	Drop Suspension Dosage Form	A suspension intended for administration in a drop-wise fashion.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C60997	Tablet Coated Particle Dosage Form	A tablet composed of a conglomerate of particles that contains active and/or inert ingredient(s) that have been individually covered with a coating.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C61004	Tablet for Solution Dosage Form	A tablet that changes into a solution when added to a liquid solvent.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C61005	Tablet for Suspension Dosage Form	A tablet that changes into a suspension when added to a liquid solution.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C61006	Orally Disintegrating Delayed Release Tablet Dosage Form	A tablet that disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue but is also designed to impede the immediate release of the active and/or inert ingredient(s) after administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C64884	Effervescent Powder Dosage Form	A powder composed of active and/or inert ingredient(s), and a mixture of acids and sodium bicarbonate, which release carbon dioxide when dissolved in water.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C64984	Intracameral Route of Administration	Administration of a medicinal product directly into the anterior chamber of the eye.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C69067	Extended Release Granules Dosage Form	A solid in the shape of a small particle or grain designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C87536	Smoke Stick Dosage Form	A pharmaceutical dosage form in the shape of a stick; when lit, it delivers medicated smoke.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C87537	Smoke Paper Dosage Form	A pharmaceutical dosage form in paper; when lit, it delivers medicated smoke.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C87538	Extended Release Intraruminal Device Dosage Form	A pharmaceutical dosage form comprised of extended release agents for intraruminal administration.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C87539	Tag Dosage Form	A pharmaceutical dosage form containing active substance(s) that are delivered via a tag device.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C87540	Delayed Release Granule for Suspension Dosage Form	A pharmaceutical dosage form comprised of delayed release granules designed to form a suspension.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C87541	Lyophilized Powder Dosage Form	A pharmaceutical dosage form comprised of lyophilized powder.			
C54456	SPL Pharmaceutical Dosage Form Terminology	C87542	Pendant Dosage Form	A pharmaceutical dosage form containing active substance(s) delivered via pendant.			
C96071	PQ/CMC Stability Study Reason Terminology	C115122	Generic Investigational New Animal Drug File	Data submitted to a generic investigational new animal drug file.	Generic Investigational New Animal Drug File		PQCMC data submitted to a generic investigational new animal drug file.
C96071	PQ/CMC Stability Study Reason Terminology	C115123	Abbreviated New Animal Drug Application	Data submitted to an abbreviated new animal drug application.	Abbreviated New Animal Drug Application		PQCMC data submitted to an abbreviated (generic) new animal drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C70877	Drug Master File	Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.	Master File		Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They 1) Allow parties to reference material without disclosing DMF contents to those parties. 2) Are not required by statute or regulation. 3) Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).
C96071	PQ/CMC Stability Study Reason Terminology	C70880	Pre-market Approval Application	An application to FDA for a license to market a new device in the United States.	Premarket Approval		PQCMC data submitted for a PMA application.
C96071	PQ/CMC Stability Study Reason Terminology	C71778	Biologics License Application	A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biological product subject to licensure under section 351 of the Public Health Service Act. A biologics license application must contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product, sufficient for the FDA to determine that the establishment and the product meet applicable requirements to ensure the continued safety, purity, and potency of the product, including but not limited to GMPs.	Biologics License Application		PQCMC data submitted to a biologics license application.
C96071	PQ/CMC Stability Study Reason Terminology	C72899	New Drug Application	A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND).	New Drug Application		PQCMC data submitted to a new human drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C72901	New Animal Drug Application	Data submitted to a new animal drug application.	New Animal Drug Application		PQCMC data submitted to a new animal drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C73113	Abbreviated New Drug Application	Data submitted to an abbreviated new drug application.	Abbreviated New Drug Application		PQCMC data submitted to an abbreviated (generic) new human drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C80440	Humanitarian Device Exemption	A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA.	Humanitarian Device Exemption (HDE)		PQCMC data submitted for an HDE application.
C96071	PQ/CMC Stability Study Reason Terminology	C80442	Premarket Device Notification	A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization).	Premarket Notification 510(K)		PQCMC data submitted for a premarket 510(k) submission.
C96071	PQ/CMC Stability Study Reason Terminology	C82667	Investigational Device Exemption	Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration.	Investigational Device Exemption		PQCMC data submitted to an investigational device exemption.
C96071	PQ/CMC Stability Study Reason Terminology	C96089	Annual Report		Annual Report		PQCMC data submitted to an annual report or update to an approved application.
C96071	PQ/CMC Stability Study Reason Terminology	C96090	Investigational New Drug Application	Data submitted to an investigational new human drug application.	Investigational New Drug Application		PQCMC data submitted to an investigational new human drug application.
C96071	PQ/CMC Stability Study Reason Terminology	C96091	Investigational New Animal Drug File	Data submitted to an investigational new animal drug file.	Investigational New Animal Drug File		PQCMC data submitted to an investigational new animal drug file.
C96071	PQ/CMC Stability Study Reason Terminology	C96092	New Active Ingredient	Data submitted for an active ingredient.	New Active Ingredient		PQCMC data submitted for an active ingredient, could be PQCMC data for an active ingredient submitted in a drug application, or a Master File.
C96071	PQ/CMC Stability Study Reason Terminology	C96094	Approved Application Supplement		Supplement to an Approved Application		PQCMC data submitted to an approved application already filed with the FDA.