Pharmacopoeia
An official reference publication containing standards for the identity, strength, quality, and purity of pharmaceutical substances and dosage forms. Pharmacopoeial standards define the testing methods and acceptance criteria that peptide drug products must meet.
Technical Context
A pharmacopoeia is an officially recognised compendium of quality standards (monographs) for drugs, excipients, and dosage forms. Each monograph specifies: identification tests, purity tests (limits for specific impurities), assay methods (quantification of active substance), and storage conditions. Major pharmacopoeias: USP (United States Pharmacopeia), Ph. Eur. (European Pharmacopoeia), BP (British Pharmacopoeia), and JP (Japanese Pharmacopoeia). Pharmacopoeial standards are legally enforceable — drugs marketed in a jurisdiction must comply with the relevant pharmacopoeia. For peptide drugs, pharmacopoeial monographs exist for established compounds (oxytocin, vasopressin, insulin, calcitonin, vancomycin, etc.) specifying HPLC purity methods, identity tests, and impurity limits. The ICH Q4B process enables mutual recognition of pharmacopoeial methods across regions.