C133807
PQ/CMC Test Category Terminology
C138990
Product Description/Appearance
Tests using visual inspection to assess the physical state and color of the drug substance or product.
Description
An assessment of the physical state (e.g., color, shape, size) of the drug substance or product. [Source: Adapted from ICH Q6A]
C133807
PQ/CMC Test Category Terminology
C138993
Material Identification
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 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. [Source: ICH Q6A]
C133807
PQ/CMC Test Category Terminology
C158423
Chemical Impurity
Any unwanted organic, inorganic, and residual solvents in drug substances and final products.
Impurities
Analytical procedures that determine the presence of a component of the material that is not the chemical entity defined as the material.
C133807
PQ/CMC Test Category Terminology
C158425
Biological Property
Characteristics of biological systems.
Biological Properties
Any effect a given material has on a living organism (e.g., microbial limits, endotoxin).
C133807
PQ/CMC Test Category Terminology
C176810
Microbiological Property
The characteristics of, or the effects of a material on a microorganism or microbiome.
Microbiological Properties
The characteristics of, or the effects of a material on a microorganism or microbiome.
C133807
PQ/CMC Test Category Terminology
C176811
Physico-Chemical Properties
The characteristics of a material associated with its composition and basic nature, including but not limited to its texture, smell, freezing point, boiling point, melting point, opacity, viscosity and density.
Physico-Chemical 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.
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.
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.
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. (NCI04)
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
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
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
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
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.
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.
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.
Generic Name
Common 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 pharmaceuitcal 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.
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.