USP: Proposed Addition to Chapter <1236> Solubility Measurements

Recommendation
Monday, 29 September 2025 14.00 - 17.00 h
A new version of the USP general chapter 〈1236〉 Solubility Measurements has been published in the Pharmacopeial Forum, PF 48(2), for public comments.
The draft is based on the version of the chapter official as of December 1, 2020. In addition to the existing text, it is proposed to add the porcine simulated gastric and intestinal fluids in the subchapter on solubility measurements in biorelevant media. Additionally, minor editorial changes have been made.
The proposal can be consulted after registration on the Pharmacopeial Forum website. Comments can be submitted until May 31, 2022.
Related GMP News
27.08.2025FDA Warning Letter: Missing Identity Tests, Unverified CoAs, and Inadequate DEG/EG Controls
20.08.2025USP Responds to Comments on Chapter <202> HPTLC Identification of Fixed Oils
13.08.2025USP publishes Comments rereived on Chapter <317>
13.08.2025FDA Issues Warning Letter to Contract Testing Laboratory for Inadequate OOS Investigations
06.08.2025EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence
06.08.2025FDA Warning Letter: Company Voluntarily Ceases Drug Production