BRIEFING

 Emulsifying Wax. This proposal is based on the version of the monograph official as of August 1, 2023. On the basis of comments and data received, it is proposed to make the following changes:

1. Update the Definition to add acceptance criteria where the sum of cetyl alcohol and stearyl alcohol is NLT 70.0%.

2. Add the Assay based on a new GC method. The proposed GC method is based on analyses performed using the Phenomenex ZB-1 brand of column with phase G1. The retention times for the cetyl alcohol and stearyl alcohol peaks are about 6.5 and 7.5 min, respectively.

3. Add USP Cetyl Alcohol RS and USP Stearyl Alcohol RS to the USP Reference Standards section.

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

 (EXC2: S. Saladi)

 Case ID—SUB-436