Standard Guide for Stability Testing of Cannabis-Based Products

Importancia y uso:

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.

Subcomité:

D37.03

Referida por:

D8500-23, D8498-23, D8499-23

Volúmen:

15.10

Número ICS:

11.120.10 (Medicaments), 65.020.20 (Plant growing)

Palabras clave:

accelerated testing; cannabinoids; cannabis; CBD; expiration date; hemp; long-term testing; marijuana; shelf-life; stability; storage; terpenes; THC;