Glossary
Plain-language definitions of the terms used across this site.
A
B
- Bacterial Endotoxin Test (BET)A bacterial endotoxin test (BET), defined in USP <85>, detects endotoxin, a component of the Gram-negative bacterial cell wall, using Limulus amebocyte lysate (LAL), a reagent from horseshoe crab blood cells.
- Batch Manufacturing Record (BMR)A batch manufacturing record (BMR) is the signed, executed record of how one specific batch was made, with actual weights, results, deviations and yield.
C
- CAS Registry Number (CAS RN)A CAS Registry Number (CAS RN) is a numeric identifier of up to 10 digits, split by hyphens into three parts, that Chemical Abstracts Service assigns to one substance.
- Certificate of Pharmaceutical Product (CPP)A certificate of pharmaceutical product (CPP) is a document the exporting country's competent authority validates and issues for a specific product, for use by the regulator in the importing country.
- Cleaning ValidationCleaning validation is documented evidence that an approved cleaning procedure consistently removes active ingredient, cleaning agent and microbial residues from product-contact equipment to predetermined limits.
D
- DEA Form 236DEA Form 236 is the Controlled Substances Import/Export Declaration filed with the US Drug Enforcement Administration (DEA) for non-narcotic controlled substances.
- Dissolution TestingDissolution testing is a laboratory test that measures how much of a tablet's labeled drug dissolves in a specified liquid at set times, as described in USP general chapter <711>.
- Drug Substance vs Drug ProductA drug substance is the active ingredient that furnishes the drug's effect; a drug product is the finished dosage form, such as a tablet, capsule or solution, that contains it.
E
- Excipient Compatibility StudyAn excipient compatibility study is a preformulation test that mixes an API with each proposed excipient, stores the mixtures under stress and checks for degradation.
- Exhibit BatchAn exhibit batch is the drug product batch made, tested and documented to support an ANDA, the abbreviated new drug application filed with FDA for a generic drug.
F
K
L
P
S
- Schedule M GMPSchedule M GMP means the good manufacturing practice rules in Schedule M of India's Drugs Rules, 1945, covering premises, plant, equipment, quality systems and records for medicines and APIs.
- Syrup vs suspensionA syrup carries a drug in a sweet, viscous vehicle, usually dissolved; a suspension holds undissolved solid particles in a liquid that settle and need shaking.
T
- Tablet CappingTablet capping is the partial or complete separation of a tablet's upper or lower crown from its body.
- Tablet ExcipientsTablet excipients are the components of a tablet other than the active ingredient.
- Tablet Friability TestA tablet friability test weighs tablets before and after tumbling and reports the percentage lost, showing their tendency to chip, crumble or break when handled.