The Role of USP Monographs in Stability Testing

摘要: For drugs, including biologics, and excipients, the US Pharmacopeial Convention’s (USP’s) role in setting public standards generally begins after Food Drug Administration (FDA) approval. Working with pharmaceutical manufacturers, FDA, USP staff, other stakeholders, USP’s Council of Experts develops standard, i.e., a drug substance monograph allied reference materials (Official Reference Substances) when needed. The product monographs contain tests, procedures, acceptance criteria (collectively referred to as specification) for an official article United States Pharmacopeia (USP) excipients are included National Formulary (NF). Articles USP–NF expected comply specification requirements until their expiration date accordance adulteration misbranding provisions Food, & Cosmetic Act, well stated General Notices (see current USP). Other bodies, e.g., countries may rely on USP–NF. Because applicable throughout shelf-life product, they important assurance adequate quality time that medicine is available patients consumers.