USP: Further Updates on "Residual Solvents" published for Comments

Recommendation

9/10 November 2023

The Impurities Forum Part I and II - Live Online Training
Practical Approaches for Assessing the Risks of Impurities

As recently reported, the USP chapter "<467> RESIDUAL SOLVENTS" has been revised and published for comment following the update of the "ICH guideline Q3C (R8) on impurities: guideline for residual solvents". As Chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information in Chapter <467>, the latter has now also been updated and the new draft is published on the USP Pharmacopeial Forum website. Comments and suggestions on this draft can be submitted until 31 March 2023.

In addition to formal changes, modifications have been made in the section "VERIFICATION OF COMPENDIAL PROCEDURES - Limit Procedures: Procedure A and Procedure B". Here, the changes are found in the sub-item "Specificity". They are also due to the addition of the substances "cyclopentyl methyl ether" and "tertiary butyl alcohol" as well as "2-methyltetrahydrofuran".

The draft chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" can be consulted and commented on after completing a one-time registration on the Pharmacopeial Forum website.