MilliporeSigma

USP Reference Standards

United States Pharmacopeia (USP) Reference Standards

United States Pharmacopeia (USP) is an independent, nonprofit, non-governmental organization founded in 1820. It aims to improve global health by setting public standards that ensure the quality of medicines and other articles. These standards are broken into two primary areas: documentary standards and physical (reference) 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).

The process of pharma development and manufacturing requires rigorous testing of drugs using physical standards – that is, Primary Reference Standards. USP Reference Standards are established to ensure quality in quality control processes. They are highly characterized drug substances and related impurities. Only after rigorous collaborative testing and evaluation by multiple independent laboratories, are these standards released.

USP Reference Standards assure accuracy in testing and enable reproduceable analytical results. In pharma manufacturing, they 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 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 identification and other analyses.

USP maintains an ever-growing catalog of highly characterized reference standards for thousands of active pharmaceutical ingredients (API), excipients, dietary supplements, and related compounds.

We stock many USP Reference Standards locally, to help ensure quick delivery. Explore our catalog of more than three thousand USP standards to find the right product for your successful analysis.

Sign In To Continue

To continue reading please sign in or create an account.

Don't Have An Account?