(1997; 248 pages) [French]
4. Analytical methods
A systematic approach should be adopted to the presentation and evaluation of stability information, which should include, as necessary, physical, chemical, biological and microbiological test characteristics.
All product characteristics likely to be affected by storage, e.g. assay value or potency, content of products of decomposition, physicochemical properties (hardness, disintegration, particulate matter, etc.), should be determined; for solid or semi-solid oral dosage forms, dissolution tests should be carried out.
Test methods to demonstrate the efficacy of additives, such as antimicrobial agents, should be used to determine whether such additives remain effective and unchanged throughout the projected shelf-life.
Analytical methods should be validated or verified, and the accuracy as well as the precision (standard deviations) should be recorded. The assay methods chosen should be those indicative of stability. The tests for related compounds or products of decomposition should be validated to demonstrate that they are specific to the product being examined and are of adequate sensitivity.
A checklist similar to that used in the WHO survey on the stability of pharmaceutical preparations included in the WHO Model List of Essential Drugs (Appendix 1) can be used to determine the other stability characteristics of the product.