D	C133856	PQ/CMC Impurity Classification Terminology	C134000	Organic Impurity	Any unwanted organic compound that is present in specifically defined substances or products and is generated during the manufacturing process or is created upon degradation during storage.	Organic Impurities (process- and product-related)		Any unwanted organic compound that is present in specifically defined substances or products and is generated during the manufacturing process or is created upon degradation during storage.
D	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 Impurities		Any unwanted inorganic compound generated during the manufacturing process of a particular substance or product.
D	C133807	PQ/CMC Test Category Terminology	C158424	Physical Property	Any of the characteristics that define the nature of matter or forces that act upon it.	Physical Properties		Assessments of the characteristics of a material that are not associated with a change in its composition and basic nature, including but not limited to its texture, smell, freezing point, boiling point, melting point, opacity, viscosity and density.
C	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133910	MDL 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.	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.
C	C133848	PQ/CMC Chemical Structure Data File Type Terminology	C133996	MDL Structure-data File	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.
C	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.
C	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.
C	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.
C	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.
C	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	Capsule shell	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.
C	C133858	PQ/CMC Interpretation Code (numeric) Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	NA || Not Applicable	NA	Determination of a value is not relevant in the current context.
C	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		
C	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.
C	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.
C	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.
C	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.
A	C176788	PQ/CMC Application Submission Type Terminology	C176796	Amendment to Original Submission	Amendment submission to the original submission as submitted by the sponsor to a regulatory agency.	Amendment to Original		Amendment submission to the original submission as submitted by the sponsor.
A	C176788	PQ/CMC Application Submission Type Terminology	C176797	Supplement to Original Submission	Supplement submission to the original as submitted by the sponsor to the regulatory agency.	Supplement to Original		Supplement submission to the original as submitted by the sponsor.
A	C176788	PQ/CMC Application Submission Type Terminology	C176798	Amendment to Supplement Submission	Amendment submission to the supplement of the original submission as submitted by the sponsor to the regulatory agency.	Amendment to Supplement		Amendment submission to the supplement of the original submission as submitted by the sponsor.
A	C176788	PQ/CMC Application Submission Type Terminology	C176802	Amendment to Investigational New Drug	An amendment to the Investigational New Drug submission as submitted by the sponsor.	Amendment to INDs		Amendment to the INDs as submitted by the sponsor.
A	C176788	PQ/CMC Application Submission Type Terminology	C176803	Amendment to Master Drug File	Amendment submission to the Master Drug File submission as submitted by the sponsor.	Amendment to Master Files		Amendment submission to the Master Files submission as submitted by the sponsor.
A	C176788	PQ/CMC Application Submission Type Terminology	C70860	Original Regulatory Submission	Original submission type as submitted by the sponsor to a regulatory agency.	Original		Original submission type as submitted by the sponsor.
A	C168639	PQ/CMC Application Type 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).
A	C176789	PQ/CMC Co-Packaged Indicator Terminology	C49487	No	The non-affirmative response to a question.	No		The non-affirmative response to a question.
A	C176789	PQ/CMC Co-Packaged Indicator Terminology	C49488	Yes	The affirmative response to a question.	Yes		The affirmative response to a question.
A	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).
A	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.
A	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.
A	C133855	PQ/CMC Drug Substance Product Indicator Terminology	C1909	Pharmacologic Substance	Any natural, endogenously-derived, synthetic or semi-synthetic compound with pharmacologic activity. A pharmacologic substance has one or more specific mechanism of action(s) through which it exerts one or more effect(s) on the human or animal body. They can be used to potentially prevent, diagnose, treat or relieve symptoms of a disease. Formulation specific agents and some combination agents are also classified as pharmacologic substances.	Product		Any natural, endogenously-derived, synthetic or semi-synthetic compound with pharmacologic activity. A pharmacologic substance has one or more specific mechanism of action(s) through which it exerts one or more effect(s) on the human or animal body. They can be used to potentially prevent, diagnose, treat or relieve symptoms of a disease. Formulation specific agents and some combination agents are also classified as pharmacologic substances.
A	C133855	PQ/CMC Drug Substance Product Indicator Terminology	C45306	Substance	Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.	SUBSTANCE		Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.
A	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)
A	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)
A	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)
A	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).
A	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).
A	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).
A	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)
A	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.
A	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.)
A	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)
A	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)
A	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)
A	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>)
A	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)
A	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)
A	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.
A	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)
A	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>)
A	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)
A	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.
A	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)
A	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)
A	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)
A	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)
A	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)
A	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.
A	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).
A	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).
A	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>)
A	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>)
A	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).
A	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)
A	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.
A	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>)
A	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)
A	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.
A	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.
A	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. (NCI04)	Antioxidant		Agent used to stabilize a system against oxidative degradation. (Adapted from Medicinescomplete)
A	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>)
A	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>)
A	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>)
A	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>)
A	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)
A	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)
A	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).
A	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.
A	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).
A	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).
A	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)
A	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).
A	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.
A	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)
A	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)
A	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)
A	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)
A	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).
A	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).
A	C176676	PQ/CMC Excipient Function 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	Capsule shell	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.
A	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		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), starting materials.
A	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.
A	C133856	PQ/CMC Impurity Classification Terminology	C84280	Contaminant	A substance that makes a material impure.	Contaminants		Contaminants in a product include all adventitiously introduced materials not intended to be part of the manufacturing process, such as chemical and biochemical materials, and/or microbial species.  Examples:  bisphenol-A diglycidyl ether (BADGE), bisphenol A (BPA,  isopropyl acetophenone,  microbial proteases, endotoxin, etc.
A	C133857	PQ/CMC Interpretation Code (text) 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.
A	C176790	PQ/CMC Process Related Impurity Category Terminology	C134000	Organic Impurity	Any unwanted organic compound that is present in specifically defined substances or products and is generated during the manufacturing process or is created upon degradation during storage.	Organic		Materials that are degradation products or residuals and are generated during a manufacturing process or storage. [Source: Adapted form ICH Q3A(R2)]
A	C176790	PQ/CMC Process Related Impurity Category 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.
A	C176790	PQ/CMC Process Related Impurity Category 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)]
A	C176814	PQ/CMC Product Related Impurity Category 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.
A	C176814	PQ/CMC Product Related Impurity Category Terminology	C176816	Degradant	An impurity resulting from a chemical change in the drug substance.	Degradants		An impurity resulting from a chemical change in the drug substance [Source: Adapted from ICH Q3B(R2)] Example:  Aggregates, Truncated Form,  etc.
A	C133860	PQ/CMC Quality Benchmark Terminology	C134006	United States Pharmacopeia-National Formulary	A set of Food and Drug Administration (FDA) quality standards for drugs, dietary supplements, excipients, procedures for tests, assays, analytical methods, and more.	USP-NF		
A	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	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	C133860	PQ/CMC Quality Benchmark Terminology	C134009	Company Standard	A trademarked, copyrighted standard belonging to an organization.	Company Standard		
A	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	C133865	PQ/CMC Storage Conditions Terminology	C133935	Temperature 5 (+/-) 3 Degrees C	Storage at 5 degrees C (+/-) 3 degrees C.	5 +/- 3 degrees C		
A	C133865	PQ/CMC Storage Conditions Terminology	C133936	Temperature -20 (+/-) 5 Degrees C	Storage at -20 degrees C (+/-) 5 degrees C.	-20 +/- 5 degrees C		
A	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		
A	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		
A	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		
A	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		
A	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		
A	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		
A	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		
A	C133865	PQ/CMC Storage Conditions Terminology	C96148	Proprietary Storage Condition	Storage conditions according to protocols set by a business or company.	Proprietary		
A	C133866	PQ/CMC Study Type Terminology	C134026	Standard Environmental Condition	A single set of environmental conditions.	Standard		
A	C133866	PQ/CMC Study Type Terminology	C134027	Cycled-Simple Environmental Condition	A set of two alternating environmental conditions.	Cycled-Simple		
A	C133866	PQ/CMC Study Type Terminology	C134028	Complex Environmental Condition	Multiple phases with different sets of environmental conditions.	Complex		
A	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		Tests which measure the content of the active ingredient in the drug substance or drug product. Synonymous with strength or purity which is commonly used of define the content of the active ingredient in a drug product. [Source: Adapted from ICH Q6A and Q6B] Note:  chiral purity, preservative content, Anti-Oxidant Concentration, Chelate Concentration, isomeric ratio.
A	C133869	PQ/CMC Testing Site Unique 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.
A	C133869	PQ/CMC Testing Site Unique 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.
A	C133869	PQ/CMC Testing Site Unique 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).
A	C133869	PQ/CMC Testing Site Unique Identifier Type Terminology	C17998	Unknown	Not known, not observed, not recorded, or refused.	Unknown		Not known, not observed, not recorded, or refused.
A	C176677	PQ/CMC Units of Measure Terminology	C105491	Kilodalton	A unit of atomic mass equal to one thousand daltons.	ku	kiloDalton	
A	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	
A	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	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C171022	Particle Total Count	A quantitative value for the total particles in a sample.	{tot}	particles	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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.	cm3 || mL	cubic centimeter || mililiter || milliliter	
A	C176677	PQ/CMC Units of Measure Terminology	C29844	Week	Any period of seven consecutive days.	wk	week	
A	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	
A	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	
A	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	Dalton	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C48154	Minute	A unit measure of time equal to 60 seconds.	min	minute	
A	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	
A	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	
A	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	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C48509	Micromole	A unit of amount of substance equal to a millionth of a mole.	umol	micromole	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C48513	Millimole	A unit of amount of substance equal to 0.001 mole.	mmol	millimole	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C48517	Nanomole	A unit of amount of substance equal to 10E-9 mole.	nmol	nanomole	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C48523	Part Per Million	A unit of proportion equal to 10E-6.	[ppm]	parts per million	
A	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	
A	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	
A	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)	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C64559	Atomic Mass Unit	A small unit of mass used to express atomic and molecular masses.	u	atomic mass unit	
A	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	
A	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	
A	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	
A	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	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C67328	Nanometer	A metric unit of length equal to to one billionth of a meter (10E-9 meter). Nanometer is used as a unit for light wavelength measurement.	nm	nanometer	
A	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	
A	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	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C69112	Part per Thousand	A unit of proportion equal to 10E-3.	[ppth]	parts per thousand	
A	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)	
A	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	
A	C176677	PQ/CMC Units of Measure Terminology	C70565	Part Per Billion	A unit of proportion equal to 10E-9.	[ppb]	parts per billion	
A	C176677	PQ/CMC Units of Measure Terminology	C70566	Part Per Trillion	A unit of proportion equal to 10E-12.	[pptr]	parts per trillion	
A	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	
A	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	
A	C133870	PQ/CMC Validation Parameter Terminology	C134032	Analyte Specificity	The ability to assess unequivocally the analyte in the presence of other components which may be expected to be present.	Specificity		
A	C133870	PQ/CMC Validation Parameter Terminology	C134033	Analytical Procedure Linearity	The ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in a sample.	Linearity		
A	C133870	PQ/CMC Validation Parameter Terminology	C134240	Analytical Procedure Range	The interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.	Range		
A	C133870	PQ/CMC Validation Parameter Terminology	C134242	Analytical Procedure Accuracy	The closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found.	Accuracy		
A	C133870	PQ/CMC Validation Parameter Terminology	C134243	Analytical Procedure Precision	The closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision and reproducibility.	Precision		
A	C133870	PQ/CMC Validation Parameter Terminology	C134244	Analytical Procedure Detection Limit	The lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.	Detection Limit		
A	C133870	PQ/CMC Validation Parameter Terminology	C134245	Analytical Procedure Robustness	The measure of a procedure's capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.	Robustness		
A	C133870	PQ/CMC Validation Parameter Terminology	C134246	System Suitability	The tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being validated.	System Suitability		
A	C133870	PQ/CMC Validation Parameter Terminology	C134248	Analytical Procedure Quantitation Limit	The lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy.	Quantitation Limit