Understanding the Expiration of Certified Reference Materials

1. Understanding the Expiration of Certified Reference Materials ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ Certified Reference Material, commonly addressed as CRM, refers to quality materials that act as a reference point for method validation, calibration, and quality control, allowing researchers and laboratories to check the reliability and accuracy of the measurements. CRMs are used across fields and industries, including biology, forensic analysis, environmental science, materials science, and chemistry. People often question the expiration of chemical reference standards or materials, and this blog focuses on answering this. CRM’s Importance in Several Industries CRM, the stable and homogeneous substances, act as crucial assets for several industries. Pharmaceutical industries use CRMs to validate the drug’s purity and potency, while environmental laboratories appropriately track pollutants using CRMs. CRMs in the research and development fields play a crucial role in developing and authenticating new/innovative analytical methods. Several standards and guides, like ISO/IEC 17025 and ISO Guides 2, stress the importance of using CRMs for validation and calibration procedures. CRM Expiration Dates The expiration date refers to the time that the standard or material can be used after the bottle is in use. The date is essential to ensure the material’s reliability and accuracy. The expiration date of CRM depends on three factors, i.e., chemical stability, human error, and physical stability. Quality CRM manufacturers have successfully eliminated chemical stability and decreased physical stability. As a result, human error or factor is left as the main concern. Transpiration or physical stability is valid in the case of every standard. The instability is because the containers transpire, and the transpiration rate rises with their use. Generally, the shelf-life of an unopened 125 ml standard or material bottle is about twenty-one months, and it decreases as the material/standard is used. Human errors are the biggest threats to reference material’s shelf life. Pipet tips, switched bottle caps, volumetric glassware, dust and vapors, loosely screwed caps, and other error

2. sources can contaminate reference standards or materials, ultimately bringing them closer to their expiration. According to many state and federal regulatory agencies, expiration dates should not cross one year. However, some agencies are stricter and need the expiration dates to be around half a year. This is because using standards and materials for more than one year significantly increases the chances of contamination or changes in the chemical components. Monitoring and Maintaining the Quality of Certified Reference Materials in Use It is important to have stringent storage practices to maintain the validity and quality of opened materials. The primary actions they should take are: ●Tightly seal the reference material’s containers to minimize their exposure to moisture, contaminants, and air. ●Store the certified reference materials or standards at their ideal temperature away from heat and light. Wrapping Up Different standards and materials can have different expiration dates. Several factors influence the dates, and not using them for more than one year is recommended. To know more and better about CRM usage and expiration, consult your certified reference materials supplier. Source: https://theclinivex.mystrikingly.com/blog/understanding-the-expiration-of-certified- reference-materials