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

5/6 May 2026
Challenges and Solutions for Packaging / Devices & Single Use Systems
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
23.04.2026Revised Chapter 2.8.25 HPTLC of Herbal Products” Published in Ph. Eur. 13.1
22.04.2026USP plans new General Chapter on Supercritical Fluid Chromatography (SFC)
08.04.2026FDA Warning Letter: Batch Release Without Appropriate Laboratory Evidence
01.04.2026FDA Warning Letter - From Garbage Bags with Analytical Records to Pre-signed and Backdated Data
31.03.2026Questions and Answers on System Suitability Tests (SST) - Part 3
31.03.2026Statistical Process Control (SPC) - Survey Result Report now Available


