Cannabinoid Certified Reference Materials (CRMs) – Need for Stringency of Characterization
This presentation will discuss USP compendial perspectives on the terminologies, needed stringency for development, qualification, value assignment, and use of CRMs for cannabis testing. These compendial perspectives about the CRMs are provide cannabis...
Director, Dietary Supplements and Herbal Medicines
Cannabinoids, the constituents of Cannabis sativa, are widely recognized as responsible for the pharmacological effects of the plant and its extracts. Label accuracy of cannabis products for cannabinoid content is critically important to help ensure patient safety and efficacy. Reports from multiple sources note the concern about “potency inflation” of cannabinoid content, where the labeled values are often 20% higher than the values measured using validated methods. While regulators require lab operations under controlled ISO 17025 conditions to help ensure label accuracy, the observed inter-lab variability may result from factors such as use of analytical methods that are not validated, improper training of lab personnel, expression of cannabinoid content on dry weight basis where the drying methods are not standardized, or the use of CRMs that are inaccurately labeled for cannabinoid levels.
Reference materials are critical components of quality systems to help ensure accuracy of labeling. USP is releasing a suite of cannabis CRMs compliant with the ISO 17034 requirements that have gone through USP’s quality assurance process. The certified value and measurement uncertainty values of these CRMs can be used by testing labs to comply with the ISO 17025 requirements.
This presentation will discuss USP compendial perspectives on the terminologies, needed stringency for development, qualification, value assignment, and use of CRMs for cannabis testing. These compendial perspectives about the CRMs are expected to provide cannabis testing labs with analytical tools to help address the observed inflation of cannabinoid labels.