USP: Proposed Addition to Chapter <1236> Solubility Measurements
Recommendation

3/4 February 2026
Evaluation, Implementation and Use of Suitable Technologies
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
26.11.2025FDA Warning Letter Highlights Deficiencies in SST and HPLC Practices
13.11.2025Proposed Revision of USP <1225> Published in the Pharmacopeial Forum
13.11.2025Recent Publications Highlighting Topics to be Discussed at PharmaLab 2025
12.11.2025USP seeks early Input on new NMR Method
12.11.2025FDA Warning Letter: Several Analytical Deficiencies Identified at Chinese Manufacturer


