Highlights

USP posts updated statements on storage and usage  (61KB), shipping conditions  (60KB), and expiration  (61KB) of Reference Standards. (09/23/08)

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USP Reference Standards—An Overview

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 (e.g., 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.

Official recognition

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 131 countries around the world.

Collaborative process

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.

What are Certified Reference Materials (CRMs)?

CRMs represent the next generation of exceptional quality Reference Standards from USP. They have undergone additional metrologically–based testing and statistical analysis to meet both USP's stringent criteria and guidelines established by the International Organization for Standardization (ISO).

CRM Features and Applications

  • Special class of USP Reference Standard (RS)
  • Metrologically–based testing and statistical analysis
  • Accompanied by a special Certificate of Analysis that complies with ISO Guide 31 data:
    • Certified property value
    • Uncertainty value
    • Expiration date/period of validity
  • Traceable to an accurate realization of the unit in which the property value is expressed
  • Trueness and traceability of CRM measurement system helps with consistency and comparability of measurement data among labs and over time
  • Data can be used for calibration, validating processes, comparison, and value assignment
  • Values meet ISO 17025 documentation requirement for testing labs
  • USP CRM program meets the requirements of ISO 17025 and ISO Guide 34 for RMP