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

Recommendation

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training
Contents of the regulatory information in the ASMF and CEP

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.