USP (United States Pharmacopeia)
The US pharmacopoeia that establishes written and physical reference standards for medicines, dietary supplements, and food ingredients. USP monographs define the quality standards (identity, purity, potency) that peptide drug substances and products must meet for the US market.
Technical Context
The USP is a non-governmental organisation that sets quality standards recognised by US federal law (Federal Food, Drug, and Cosmetic Act). USP standards include: drug substance monographs (identity, purity, strength), drug product monographs (dissolution, content uniformity, stability), general chapters (numbered <1-999> are enforceable when referenced in monographs; ≥1000 are informational), and reference standards (authenticated materials for analytical comparison). Key USP general chapters for peptide drugs: <71> Sterility Testing, <85> Bacterial Endotoxins Test, <788> Particulate Matter in Injections, <797> Pharmaceutical Compounding — Sterile Preparations, <1207> Package Integrity Evaluation. USP also establishes dietary supplement standards. The USP Medicines Compendium provides standards for drugs not yet in the USP-NF. Compliance with USP standards is verified through FDA inspections.