Why does a USP CRM have an expiration date (period of validity) and what does the expiration date mean?
The expiration date (period of validity) of a CRM is required by ISO Guide 31 [1]. The CRM property value and uncertainty is applicable to the unopened vial for the stated period of validity. It is expected that the USP Reference standard will be used when opened. USP generally provides enough material for multiple preparations. Any unused portions remaining after the container has been opened should be carefully stored in accordance with prudent laboratory procedures. There are many variables outside of the control of USP. Therefore, USP makes no warranties concerning the continued suitability of previously opened Reference Standards, hence Certified Reference Materials. Decisions concerning the proper use of previously opened Reference Standards are the responsibility of the purchaser.
Related Questions
- If a CRM/RS lot is exhausted, which expiration date should be used, the valid use date of the RS/CRM lot or the CoA period of validity?
- Why does a USP CRM have an expiration date (period of validity) and what does the expiration date mean?
- Why does a USP CRM have an expiration date and what does the expiration date mean?
