Tests which measure the content of the active ingredient in the drug substance or drug product.of a substance. Synonymous with strength or purity which is commonly used of define the content of the active ingredient in a drug product. Note: chiral purity, preservative content, Anti-Oxidant Concentration, Chelate Concentration, isomeric ratio

Tests that verify the content and potency of a pharmaceutical substance that is intended effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Methodology used to determine the amino acid composition or content of proteins, peptides, and other pharmaceutical preparations

Test that screens for aerobic mesophilic bacteria and fungi.

Tests that measures the secondardy ion of a drug salt.

Testing of the amount of material other than the active or adjuvant.

Measurement of DNA that comes from cell substrate used to make the viral particles.

Test to determine the percentage of total protein that functions in interaction with other (non-polypeptide) chemical groups attached by covalent bonding.

Testing methods to identify actives and indirectly measure impurities that may be present in a medicine. Examples of analytical procedures for this test #SUBCategory include SDS-page and HPLC.

Tests designed to reveal the presence of a particular nucleic acid from a test sample.

Identifcation of hydrates or solvates by the assay of water of crystallization or solvent found in the crystal.

Test to determine total protein concentration in the product

Tests to determine Cell and Gene therapy product properties. Examples: Viability, Cell number, Morphology, Cell surface markers, Secreted molecules, Gene expression, Genetic stability, percent recovery, gene expression, cell surface marker expression, proliferation capacity, total cell number, cell morphology, cell distribution in scaffold, total volume of scaffold, cellular pattern, vector genome concentration, vector infectious titer assay, replication competence assay, DNA homogeneity, transduction efficiency, vector genome concentration, vector infectious titer assay, Replication competence assay [Source: SME Defined]

Tests for the adequacy of pharmaceutical packaging and closures.

Tests to ensure the consistency of the API in the formulation. Test may be done as an IPC, release or stability test.

Tests of the variability of the dosage unit including dispensed dose.

Content Uniformity based for multi-use containers, tubes and jars.

Tests designed to provide assurance that oral liquids will, when transferred from the original container, deliver the volume of dosage form that is declared on the label of the article.

Evaluation via the senses—including taste, sight, smell, and touch.

Tests using visual inspection to assess the physical state and color of the drug substance or product.

Testing via the sense of smell.

The use of visual perception to indicate of purity and/or a means to identify contamination.

Measurement of the turbidity of the solution or; Qualitative or quantitative measurement of degree of opalescence of a solution. Instrumental measurement of the light reflected by the solution.

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]

Test to determine whether tablets capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.

Test to determine compliance with the requirements of the material of interest dissolving into solution. A dosage unit is defined as 1 tablet or 1 capsule or the amount specified.

Tests that determine the size of the liquid drop [Source: SME Defined]

Tests for injections or infusions to check for insoluble particles to confirm that they are not present in excess of specified levels in the solutions [Source: Adapted from ICH Q4B].

Tests for metallic particles to confirm that they are not present in excess of specified levels. [Source: SME Defined]

Analytical procedures to determine the amount of volatile matter of any kind that is driven off under the conditions specified.

Tests for the estimation of the number of viable aerobic microorganisms present and for the freedom from designated microbial species in the pharmaceutical articles of all kinds, from raw materials to the finished forms.

Osmolality and osmolarity are measurements of the solute concentration of a solution. Osmolality is expressed in terms of the weight of the solvent and osmolarity is expressed in terms of solvent volume. [Source: SME Defined]

Analytical procedures that utilize mechanical sieving for deducing the particle-size distribution of a powdered solid.

Tests that determine the ratio of the mass of an untapped powder sample and its volume including the contribution of the interparticulate void volume.

Electrical conductivity is a measure of the ion-facilitated electron flow through it.

The detection and/or quantification of the amount of amorphous material within a highly crystalline substance.

The percent loss of a tablet due to mechanical action that results in fracture or breaking during the test

A test used to identify the ability of a material to resist mechanical deformation such as scratching or penetration by other substances.

The temperature at the which a substance changes from solid to a liquid state at atmospheric pressure.

A property of many pharmaceutical substances to rotate an incident plane of polarized light so that the transmitted light emerges at a measurable angle to the plane of the incident light. [Source: Adapted from USP <781>]

The measure of acidity or alkalinity of an aqueous solution.

A chemical property referring to the ability for a given substance, the solute, to dissolve in a solvent. It is measured in terms of the maximum amount of solute dissolved in a solvent at equilibrium

The ratio of the density of any substance to the density of some other substance taken as standard, water being the standard for liquids and solids, and hydrogen or air being the standard for gases.

Dimensions and physical properties of the material of interest including tablets, capsule, soft gel capsule, granulate or pellet, etc.

The weight of a single unit of the material of interest. Examples: 800 mg (a tablet) [Source: SME Defined]

The sum total weights of the material of interest units or sum total of the material of interest divided by the number of units included in the sum. Example: 790-810 mg, 100 mg (per 10), 10 mg (per tablet) note: for a QS or IPC this is likely a range but as a result it would be a single value note: the unit would indicate if the value represents a total weight of the group or the average weight across the group - both values could be provided [Source: SME Defined]

The difference in weights of the material of interest. Examples: 2%, 5 mg, 2.5 % note: may be a percent, a value or a percent relative standard deviation [Source: SME Defined]

The weight of material of interest within a single unit. Example: 1 gram (in each vial), 200 mg (in each capsule) note: could be a capsule, vial or bottle ote: for a QS or IPC this is likely a range but as a result it would be a single value [Source: SME Defined]

The sum total weights of material of interest across multiple units divided by the number of units included in the sum. Example: 790-810 mg, 100 mg (weight of 10 tablets), 10 mg (per tablet) note: for a QS or IPC this is likely a range but as a result it would be a single value note: the unit would indicate if the value represents a total weight of the group or the average weight across the group - both values could be provided [Source: SME Defined]

A predetermined percentage weight increase for a set of units resulting from of an action such as coating. Example: 3% (weight gain after coating) note: this can be associated with a bulk material or a single unit [Source: SME Defined]

The weight of outer casing ('shell') into which material of interest is filled. Example: 20 mg [Source: SME Defined]

The position of hole drilled in the unit dose. [Source: SME Defined]

The length of a straight line measurement across the center of the hole drilled in the unit dose. [Source: SME Defined]

The measurement of the penetration of the hole drilled in the unit dose as measured from the outer edge to the deepest point of penetration. [Source: SME Defined]

An observation if one or both sides of the unit dose has been drilled. [Source: SME Defined]

The total count of holes drilled in the unit dose [Source: SME Defined]

The dimension between two surfaces of a continuous sheet of compressed material in preparation for subsequent processing. [Source: adapted from Thickness]

The compactness of a continuous sheet of compressed material in preparation for subsequent processing [Source: adapted from Density]

The measurement of overlap common to two edges of the same material joined together. Example: 1 mm [Source: SME Defined]

The length of a straight line measurement from the longest edge-to-edge distance through a Capsule body and cap that have been coupled such that the locking rings are sealed as designed. [Source: SME Defined]

The length of a straight line measurement from the longest edge-to-edge distance through the Tablet/Capsule. [Source: SME Defined]

The length of a straight line measurement across the circular center of a Tablet/Capsule. [Source: SME Defined]

The length of a straight line measurement from the shortest edge-to-edge distance through a Tablet. [Source: SME Defined]

An increased bulk density attained after mechanically tapping the container containing the powder sample. (aka - tapped density)

Tests that determine the physical properties of transdermal systems [Source: SME Defined] Example, Peel adhesion test, Tack test, Cold Flow test, etc.

A property of liquids that is closely related to the resistance to flow.

A test that measures the spray pattern characteristics, including shape and size of the evolving spray cloud under defined experimental and instrumental test conditions [Source: Adapted from USP-NF]

Tests to determine the different crystalline forms of a given drug substance [Source: Adapted from ICH Q6A]. BACKGROUND Polymorphism -- The occurrence of different crystalline forms of the same drug substance. This may include solvation or hydration products (also known as pseudopolymorphs) and amorphous forms.

Tests that measure the empty spaces/voids in the material. [Source: SME Defined]

Tests to measure the biological activity using a suitably quantitative biological assay (also called potency assay or bioassay), based on the attribute of the product which is linked to the relevant biological properties [Source: Adapted from ICH Q6B]

Tests designed to limit to an acceptable level the risks of febrile reaction in the patient to the administration, by injection, of the product concerned. The test involves measuring the rise in temperature of rabbits following the intravenous injection of a test solution and is designed for products that can be tolerated by the test rabbit in a dose not to exceed 10 mL/kg injected intravenously within a period of NMT 10 min.

Measurement of how long it takes to restore something dried to its original state of liquid.

Testing of oral suspensions that settle on storage (produce sediment) to measure the time required to achieve resuspension.

Tests performed to determine the ratio of velocity of light in air to the velocity of light in the substance. [Source: Adapted from USP <831>]

Tests to measure the amount of residual substance not volatilized from a sample when the sample is ignited in the presence of sulfuric acid. This test is usually used for determining the content of inorganic impurities in an organic substance. [Source: Adapted from USP <281>]

Tests to determine the size of the mist formed by spraying. The measurement is made for the longest axis (x axis), and the ratio of longest to shortest axes (x/y ratio).[Source: Adapted from USP-NF]

Tests done under aseptic conditions to ensure that there are no contaminating micro-organism present in the sample [Source: Adapted from USP <71>]

Tests performed on syringes to ensure that It operates as specified []

An indirect measure of organic molecules present in pharmaceutical waters measured as carbon [Source: USP <643>].

Test that measures what amount of force is needed to alter the mechanical integrity of a construct.

Total surface area of a 2D or 3D materials

Test to measure if the protein undergoing post translational modification which include glycocylation etc.

Post translation modification due to addition of sugar

Map of peptides derived from digestion of protein with thrombin

Post translational modification of proteins by sialylation

Testing for and acid containing residue conversion to an amide.

Testing for an amide residue conversion to an acid.

Functional assay used to quantify functioning of an active substance rather than just its quantity. Common uses are: showing that a drug target fits the desired functionality and quality profile before moving on to the next stage of development; and comparison of biosimilars with innovator products.

The relative proportion of elements present

Measurement of the clarity and degree of opalescence of liquids by comparison of the solutions in diffused daylight after preparation of the reference suspension.

Analytical procedures to establish material purity by determining the presence of a material or component of a material that is not defined as the material.

Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and for which a structured characterization has been achieved. Note: this includes degradation products for tests conducted on drug products. [adapted from ICH Q3A (R2) & Q3B (R2)]

Testing for an impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance or drug product specification and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time) due to the lack of achieving a structured characterization. Note: this includes degradation products for tests conducted on drug products. [adapted from ICH Q3A (R2) & Q3B (R2)]

Testing for an impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug substance or drug product specification. Note: this includes degradation products for tests conducted on drug products. [adapted from ICH Q3A (R2) & Q3B (R2)]

The sum of all impurities at a level greater than (>) the reporting threshold. Note: this includes degradation products for tests conducted on drug products. [adapted from ICH Q3A (R2) & Q3B (R2)]

The sum of unknown (unidentified) impurities in a new drug substance or drug product specification. Note: Total impurities includes all impurities while Total Unknown impurities only includes all the unknown impurities. [Source: SME Defined]

Identification (chemical name and/or UNII code) of all the identified (known) impurities that are being controlled as “unspecified impurities” rather than “Specified Identified Impurity” due to the level being consistently below the ICH identification threshold (IT) value. Note: this includes degradation products for tests conducted on drug products. [Source: SME Defined]

Analytical procedures that determine the amount of single elements in drug products or drug product components.

Analytical procedures to establish chemical purity by determining the presence of a component of the material that is not the chemical entity defined as the material.

Tests that establishes the characteristic and uniqueness of the the substance of interest and should be able to discriminate between compounds of closely related structures which are likely to be present. Includes leachables and extractables.

Tests performed to determine if organic volatile chemicals that are used or produced in manufacture of drug substance or excipients, or in the preparation of drug products are present in the pharmaceuticals. [Source: Adapted from USP <467>] BACKGROUND: For pharmacopeial purposes, residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products.