Pharmeuropa Publishes Comments on New Dissolution Testing Chapters

Pharmeuropa has released the “Comments concerning texts published in Issue 12.3,” outlining explanations for new, revised and corrected texts adopted by the European Pharmacopoeia Commission. Among the updates are two chapters focused on dissolution testing: 2.9.42, Dissolution test for lipophilic solid dosage forms, and 2.9.43, Apparent dissolution.

Both chapters were previously issued for public consultation in Pharmeuropa Issue 36.3. Detailed explanations of the revisions and clarifications introduced during the adoption process are available in an accompanying PDF published by Pharmeuropa.

The finalized texts will be included in Edition 12.3 of the European Pharmacopoeia, scheduled for publication in January 2026. The new and revised requirements will become legally effective from 1 July 2026, allowing stakeholders time to review and prepare for compliance with the updated dissolution testing standards.

09-01-2026