Revised Ph. Eur. Chapters 2.9.42 and 2.9.43 on Dissolution Testing
Recommendation

23/24 June 2026
Development / Quality Control and in vivo Relevance
In Pharmeuropa, the “Comments concerning texts published in Issue 12.3” have been published. This provides the explanations relating to the new, revised and corrected texts adopted by the European Pharmacopoeia Commission. These include two chapters on dissolution testing:
- 2.9.42. Dissolution test for lipophilic solid dosage forms
- 2.9.43. Apparent dissolution
Both texts were previously published for comment in Pharmeuropa Issue 36.3. Further information on the changes can also be found in the PDF document published in Pharmeuropa.
The new texts will be published in Edition 12.3 of the European Pharmacopoeia in January 2026 and will be effective from 1 July 2026.
Related GMP News
07.01.2026Korean MFDS Publishes Data Collection on Dissolution Test Methods
18.12.2025FDA Form 483: Excel-Based Data Falsification and Duplicate Log Books
18.12.2025Questions and Answers on System Suitability Tests (SST) - Part 1
18.12.2025PharmaLab 2025: Brief Summary of AQCG Track - Save the Date for 2026!
18.12.2025FDA Warning Letter: 1,500 OOS Results with Numerous Inadequate Investigations


