Sponsors should refer to the General Chapters available in the current Schedule B pharmacopoeia for general dissolution and drug release specifications [e.g., United States Pharmacopeia (USP) , USP , European Pharmacopeia (Ph.Eur.) 2.9.3].
European Pharmacopoeia 8.0 Pdf 31
The International Council for Harmonisation (ICH) has developed a guideline, Q4b: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions which describes a process for the evaluation and recommendation of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Where the ICH Q4B annexes have been adopted by Health Canada, such changes should be reported as a change from a House analytical procedure to a Schedule B analytical procedure (see Appendix 1- Human Pharmaceuticals, change numbers 9c and 32c) with supporting analytical method validation data, where appropriate.
Multi-point dissolution profiles should be performed in at least three (3) media covering the physiological range (pH 1.2 - 6.8), e.g., 0.1N HCl, and pharmacopoeial buffer media for the proposed and currently accepted formulations. Adequate sampling should be performed at 15, 30, 45, 60, and 120 minutes until either 90% of drug from the drug product is dissolved or an asymptote is reached. 2ff7e9595c