Dissolution Testing - Planned Revision of the USP Chapter

Recommendation

6/7 February 2020
Munich, Germany

Quality Control of Starting Materials (APIs and Excipients)

A "Stimuli to the Revision Process" article on the development and validation of dissolution testing methods has been published in the Pharmacopoeial Forum 40(1). The revision of General Chapter <1092> is planned.

General Chapter <1092> should be read together with the general chapter on "In Vitro and In Vivo Evaluation of Dosage Forms" <1088> and the general chapter on "Validation of Compendial Procedures" <1225>.

According to the title of General Chapter <1092> it seems like the dissolution test comprises a single procedure which can be developed and validated. Yet, the dissolution test actually requires two procedures which have to be performed sequentially. The sample preparation procedure is generally seen as the "dissolution test", which is followed by quantification of the dissolved drug. In the future, the second part will be referred to as "analytical finish". There will thus be greater differentiation between those two development stages.

The proposed sections of the revised chapter <1092> are as follows:

• Introduction
• Preliminary Assessment
• Method Development
• Analytical Finish
• Automation
• Validation
• Acceptance Criteria

A concrete date for the implementation of the proposal hasn't been set yet.

You can find all information on the USP Website of the Pharmacopeial Forum (PF).
 
Source: USP - www.usp.org