CRMs

USP Certified Reference Materials (CRMs) 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). A USP CRM is accompanied by a special Certificate of Analysis (COA) that lists certified property value with associated uncertainty, expiration date, and additional information. The CRM provides a trueness of measurement that ensures traceability and provides a higher degree of confidence in the analytical measurement that leads to decisions regarding product specification and acceptance limits. The USP CRM program meets the requirements of ISO 17025 and ISO Guide 34 for Reference Material Producers (RMP).

CRM Features and Applications

• CRMs are a special class of USP Reference Standard
• 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