首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
现行 ASTM D8309-21
到馆提醒
收藏跟踪
购买正版
Standard Guide for Stability Testing of Cannabis-Based Products 大麻基产品稳定性试验的标准指南
发布日期: 2021-06-01
1.1 本指南适用于从事加工、测试、包装、标签和储存供人类消费的大麻产品(包括源自大麻的产品)的商业加工商和制造商。大麻籽和大麻籽衍生产品不在本指南范围内。本指南描述了为确定适当的储存条件和保质期而对新大麻产品进行稳定性测试的最低要求。 1.2 本指南适用于所有商业制造和分销供消费者使用的大麻衍生产品,无论其衍生的大麻植物类型如何。 1.3 单位- 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 稳定性测试提供了证据,说明在温度、湿度和光线等各种环境因素的影响下,大麻产品的质量和安全性如何随时间而变化。稳定性测试还将确定大麻产品的重新测试期或建议储存条件下大麻产品的保质期。建议的测试条件基于ICH Q1A。 4.2 本指南中定义的测试条件的选择基于对欧盟委员会(EC)、日本和美国三个地区气候条件影响的分析。 世界任何地区的平均动能温度都可以从气候数据中得出,世界可以分为四个气候区,即I-IV。 4.3 监管机构或政府部门的要求取代本指南中的建议。
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. ====== 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.
分类信息
关联关系
研制信息
归口单位: D37.03
相似标准/计划/法规