BRIEFING

 Stearyl Alcohol. This proposal is based on the version of the monograph official as of August 1, 2025. On the basis of comments and data received, it is being proposed to make the following changes:

1. In Organic Impurities, Procedure 1: Limit of Related Fatty Alcohols, add linoleyl alcohol to the System suitability solution and update the Acceptance criteria to include related unsaturated fatty alcohols.

2. Remove the test for Fats and Fixed Oils 〈401〉, Iodine Value. The existing GC-FID method used in Organic Impurities, Procedure 1: Limit of Related Fatty Alcohols is a reliable alternative to the traditional titrimetric iodine value analysis. The GC-FID method demonstrated strong linearity and accuracy when compared with the Hanus iodine value (IV) method, making it a robust tool for assessing unsaturation in fatty alcohols.

3. Update the USP Reference Standards section to add USP Linoleyl Alcohol RS.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (CE: S. Saladi)

 Case ID—SUB-604