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

Monday, 21 September 2026 14.00 - 16.00 h
Regulatory Landscape: ECHA, USP, Pharmacopoeias and FDA Enforcement
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.
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