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USP releases first certified reference material

Rockville, Md., September 24, 2008 The U.S. Pharmacopeial (USP) Convention is pleased to announce the release of its first Certified Reference Material (CRM), Dextromethorphan Hydrobromide. USP recently became the first global pharmacopeia to receive International Organization for Standardization accreditation as producer of chemical CRMs.

This release provides pharmaceutical manufacturers with a new class of reference standard that ensures improved information for measurements of their products when meeting requirements set forth in the United States PharmacopeiaNational Formulary (USPNF). Each CRM comes with a Certificate of Analysis containing data on certified property value, uncertainty value and for the first time an expiration date (period of validity), all of which aim to produce a higher level of trueness and traceability in the measurement of product and ingredient specifications.

"The Dextromethorphan Hydrobromide CRM is a milestone for USP since it represents our first Certified Reference Material," said William Koch, Ph.D., USP's chief metrology officer. "By releasing the first pharmaceutical CRM from any pharmacopeia, USP is maintaining the high levels of scientific and metrological leadership that customers, regulators and practitioners around the world have come to expect from us."

Additional CRM features and applications include:

  • Metrologically based testing and statistical analysis;
  • 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 for calibration, validating processes, comparison and value assignment;
  • Values meet ISO 17025 documentation requirement for testing labs; and
  • CRM program meets the requirements of ISO 17025 and ISO Guide 34 for RMP.


Contact: Sandra Kim
US Pharmacopeia

Page: 1

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