Pharmeuropa: Revised Chapter 2.9.1. "Disintegration of tablets and capsules" published for comment
Recommendation
3/4 February 2026
Evaluation, Implementation and Use of Suitable Technologies
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
In the Pharmeuropa issue 35.2, a proposal for a revised chapter 2.9.1 "Disintegration of tablets and capsules" was published. The deadline for submitting comments is 30 June 2023.
The test of disintegration is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under the experimental conditions presented in the chapter.
According to the briefing notes, compared to the monograph published in the 11th Edition of the Ph. Eur., the following changes are proposed:
- "Test B (intended for tablets and capsules larger than 18 mm) has been harmonised.
- A reference to ISO and ASTM standards has been added for the low-form beaker.
- An additional requirement for the inner diameter of the beaker used for Test B has been introduced.
- The general chapter also now explicitly allows the use of automatic disintegration detection instruments."
The full text and further details on the revision and can be found, after registration, on the Pharmeuropa website.
Related GMP News
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
17.12.2025FDA Warning Letter Criticises Handling of OOS Results at a Contract Laboratory
17.12.2025FDA Warning: No Recall Conducted Despite Confirmed Benzene Impurity