Pharmeuropa: Revised Chapter 2.9.3. Dissolution Test for Solid Dosage Forms published for comment

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

In the Pharmeuropa issue 35.1, a proposal for a revised chapter 2.9.3. Dissolution test for solid dosage forms was published. The deadline for submitting comments is 31 March 2023.

Compared to the monograph published in the 11th Edition of the Ph. Eur., the following changes are proposed:

• "The text has been edited to improve its clarity and to harmonise the terminology;
• the temperature requirement for the dissolution medium is now given with one digit after the decimal point to be consistent with the required accuracy requirement;
• the requirement for the pH value of the buffer solutions is now stated with two digits after the decimal point to be consistent with the required accuracy requirement;
• the section entitled Apparatus 3 (under Procedure) has been updated to indicate that the apparatus can be operated in two different ways (a) by conducting the test in one vessel or (b) by conducting the test using consecutive vessels."

The full text and further details on the revision and can be found, after registration, on the Pharmeuropa website.