USP Certified Reference Materials
USP Certified Reference Materials (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). The USP CRM program meets the requirements of ISO 17025 and ISO Guide 34 for Reference Material Producers of chemical CRMs.
The CRM provides a trueness of measurement that assures traceability and provides a higher degree of confidence in the analytical measurement. A USP CRM is accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a period of validity.
CRMs are Reference Standards and may be used for calibration, procedure validation, comparison of measurement results over time and among laboratories, and value assignment.
A CRM Is a Material
- Sufficiently homogeneous and stable with reference to specified properties,
- Established to be fit for its intended use in measurement,
- Accompanied by documentation,
- Issued by an authoritative body,
- Providing one or more specified property values,
- With associated uncertainties and traceabilities,
- Using valid procedures 1.
1 International Vocabulary of Metrology – Basic and General Concepts and Associated Terms (VIM): 3rd Edition, 2007