What are Certified Reference Materials?

Certified Reference Materials (CRMs) are analytical standards primarily used in ISO/IEC 17025 accredited testing and calibration laboratories and clinical laboratories accredited by the ISO 15189 standard to ensure a high level of data quality and control, which is required for the accuracy and metrological traceability needed to perform quantitative measurements.

Rigorous quality systems accredited under ISO/IEC 17025 establish this assurance by using CRMs that are produced by reference material producers accredited to the ISO 17034 standard. Cayman holds both ISO/IEC 17025 and ISO 17034 accreditations, recognizing our commitment to maintaining the highest level of quality established by the International Organization for Standardization (ISO).

The Importance of CRMs in Analytical Chemistry

CRMs are crucial because analyses rely on their known composition, properties, and uncertainty values for accurate testing and calibration. This is especially critical in situations where these measurements are used in legal or regulatory decision making, such as in forensic toxicology or clinical laboratories.

Because of the implications of these quantitative measurements, it is paramount to ensure the reliability and credibility of reported data. Many international guidelines for quality, including ISO/IEC 17025 and international forensic guidelines, state that CRMs produced under ISO 17034 may be used without further evaluation for either calibration or control purposes.

However, some procedures may require a secondary source of reference materials to enhance the reliability and credibility of analytical measurements. This includes calibration verification and the preparation of laboratory non-zero control stocks that are used to measure the accuracy of the methodology.

What are Alternate Batch CRMs?

Based on the accrediting body's regulation, this secondary source can either be a different batch number from the same vendor or a batch obtained from a second vendor (if an alternate vendor is available). If procured from the same provider, the two CRM batches will be made identically. The two CRM batches will be made identically but prepared uniquely and have undergone independent quality control and certification.  

Alternate Batch CRMs Now Available

Cayman has recently added Alternate Batch CRMs to select products in our Forensics catalog. An Alternate Batch CRM is available to customers who are required to purchase a second/alternate batch CRM when preparing independent calibration and non-zero control stocks while doing quantitative analysis. These Alternate Batch CRMs have been prepared, tested, and certified independently under the same processes and specifications as the primary CRM equivalent but in different batches.

If a CRM has an Alternate Batch available it will be mentioned in the product features, description, and Alternative(s) Product Relationship dropdown on the product page.

Alternate Batch CRM Ordering Information

Ordering an Alternate Batch CRM as a separate Item No. allows for simplicity and confidence in the ordering process. Customers needing two independent batches of the same item should add both Main Item and Alt. Batch Item to a cart or on a purchase order to guarantee that they will receive two batches of the desired product.

For example, customers that wish to purchase two independent batches of THCA-A (CRM) would add items "THCA-A (CRM)" and "THCA-A (Alt. Batch CRM)" to their cart using their independent item numbers ISO60175 and 41194, respectively. Customers only needing one batch of a CRM should purchase the Main Item.

If an Alternate Batch CRM version is not readily available, customers may continue to request an Alternate Batch on their purchase order or by contacting sales@caymanchem.com for a quote.