BRIEFING

 Cetyl Alcohol. This proposal is based on the version of the monograph official as of November 1, 2020. On the basis of comments and data received, it is proposed to make the following changes:

1. In Organic Impurity Test 1: Limit of Related Fatty Alcohols, add USP Linoleyl Alcohol RS to the Resolution solution and update the Acceptance criteria to include related unsaturated fatty alcohols.

2. Remove the test for Fats and Fixed Oils 〈401〉, Procedures, Iodine Value. The existing GC-FID method for determining the 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-376