The Role of USP Monographs in Stability Testing

Abstract

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