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Significance and Use
4.1 Stability testing provides evidence on how the quality and safety of cannabis-based product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. The stability testing will also establish a re-test period for the cannabis product or a shelf-life for the cannabis product under recommended storage conditions. Recommended test conditions are based on ICH Q1A.
4.2 The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the European Commission (EC), Japan and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV.
4.3 Requirements of regulatory bodies or governmental departments supersede the recommendations in this guide.
1.1 This guide is applicable to commercial processors and manufacturers engaged in the processing, testing, packaging, labeling, and storage of cannabis products intended for human consumption, including those derived from hemp. Hemp seed and products derived from hemp seed are excluded from the scope of this guide This guide describes the minimum requirements for conducting stability testing of new cannabis products with the purpose of determining appropriate storage conditions and shelf-life.
1.2 This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use, regardless of the type of cannabis plant from which they were derived.
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ICH DocumentsQ1B Harmonised Tripartite Guideline Stability Testing: Photostability Testing of New Drug Substances and Products
D8270 Terminology Relating to Cannabis
D8282 Practice for Laboratory Test Method Validation and Method Development
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM D8309-21, Standard Guide for Stability Testing of Cannabis-Based Products, ASTM International, West Conshohocken, PA, 2021, www.astm.orgBack to Top