USP Reference Standards
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What are Reference Standards?
USP's official Reference Standards are highly characterized specimens of drug substances, excipients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. They are required for use in conducting official USP–NF tests and assays.
The Reference Standards are typically used to conduct USP–NF:
• Identification tests
• Limit tests for impurities or related compounds
• Assays for drug substances and for formulations
• System suitability tests
USP Reference Standards are also used as calibrators—for dissolution, particle count, melting point, and standardization of titrants and as blanks and controls. Reference Standards are used mainly in chromatographic and spectrophotometric procedures.
In addition to USP–NF-based standards, USP provides Reference Standards specified in the Food Chemicals Codex as well as authentic substances—high—quality chemical samples—as a service to analytical, clinical, pharmaceutical, and research laboratories.
USP Reference Standards are based directly on official monographs in the USP–NF, whose standards and procedures are enforceable by the U.S. Food and Drug Administration (FDA). Therefore, USP Reference Standards are recognized as the official standards in the U.S., and their use makes it easier to comply with statutory requirements. USP's Reference Standards are widely recognized and trusted in more than 130 countries around the world.
USP Reference Standards are established through a collaborative testing that involves USP, the pharmaceutical industry, and FDA laboratories. Learn more about the development process for USP Reference Standards and see how the pharmaceutical industry can participate in this process.