United States Pharmacopeia (USP) Reference Standards

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What is USP?

The United States Pharmacopeia (USP) is an independent, nonprofit, non-governmental organization founded in 1820. Intending to improve global health, USP has set up public standards that help ensure the quality of medicines and other articles. There are two different types of standards: documentary standards and physical (reference) standards.

Documentary standards:

USP documentary standards are expressed in an article’s monograph, general notices, and applicable general chapters. USP’s primary compendia of standards are the United States Pharmacopoeia and the National Formulary (USP-NF).

Reference Standards:

The process of pharmaceutical development and manufacturing requires rigorous testing of drugs and their components using physical reference standards. To help ensure confidence and facilitate development of their products, many manufacturers prefer to use primary reference standards, like USP RS, which provide conclusive results where USP or NF tests call for the use of a USP Reference Standard. They are highly characterized substances, including impurities. Only after rigorous collaborative studies and evaluation by multiple independent laboratories, are these standards released.

Why Use USP Standards?

USP’s Primary Reference Standards are established to help ensure accuracy in testing and enable reproducible analytical results. In pharmaceutical manufacturing, they help accelerate product development by saving time invested in multiple rounds of testing. Drug manufacturers surveyed by USP have stated that USP Reference Standards help with reduced risks of abbreviated new drug application (ANDA) rejection by the FDA.

These reference standards are authorized for use in quantitative analyses of drug substances and formulations. Official USP tests published in monographs include identity/identification and other analyses.