USP Reference Standards are highly-characterized physical specimens used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality, and purity of medicines (drugs, biologics, and excipients), dietary supplements, and food ingredients. Our Reference Standard collection consists of more than 3,100 items ranging from drug substances, related impurities, residual solvents, biologics, excipients, botanicals, polymers, Near-IR and dissolution calibrators, photomicrographs, and melting point standards.
USP Reference Standards are closely tied with the documentary standards published in the USP–NF, Food Chemicals Codex, and Dietary Supplements Compendium. Materials based directly on official monographs in the USP–NF—whose standards and procedures are enforceable by the U.S. Food and Drug Administration—are recognized for use in official standards in the United States, and their use is effective in demonstrating compliance with statutory requirements. Read More
In continuing efforts to establish standards based on the best available science, USP has begun developing select Reference Standards as Certified Reference Materials (CRMs). The USP study design for a CRM utilizes a metrologically-based testing procedure for one or more specified properties of the material, with additional testing to provide appropriate data for statistical analysis. Learn more about CRMs.
The quality and accuracy of reference materials are essential to the manufacture of quality medicines and foods. Maintaining and growing USP's collection takes the concerted effort of industry donors and experts, regulatory agencies, USP staff, and the volunteers of the USP Council of Experts. Through this collaborative process, USP strives to produce Reference Standards of the highest quality and make them readily available to the public.
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