Pharmeuropa: Revised Chapter 2.9.1. "Disintegration of tablets and capsules" published for comment

Practical Statistical Tools for Analytical Laboratories

Recommendation

1/2 October 2024
Barcelona, Spain

Practical Statistical Tools for Analytical Laboratories
Performance Evaluation and Monitoring for compliant Analytical Procedures and Processes

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.