USP
United States Pharmacopeia · usp-nf
The official compendium of drug-substance, excipient and dosage-form quality standards in the US. USP–NF monographs are enforceable by FDA under FD&C §501.
USP publishes the United States Pharmacopeia and National Formulary (USP–NF) — the legally enforceable quality standards for drug substances, excipients and dosage forms marketed in the US. A drug that fails to meet its USP monograph is, by statute, adulterated.
Key general chapters: <61>/<62> microbial limits, <85> endotoxin, <711> dissolution, <905> uniformity of dosage units, <1058> analytical-instrument qualification, <1224>/<1225>/<1226> method validation/verification/transfer.
V5 captures USP monograph and general-chapter references on every spec, and binds release-test results to the cited method.
- USP-NF
- FD&C §501