BRIEFING

 Fumaric Acid. This proposal is based on the version of the monograph official as of December 1, 2022. On the basis of comments and data received, the following revisions are being proposed:

1. Revise the System suitability requirements for the resolution between the lactic acid and acetic acid peaks from NLT 2.0% to NLT 1.5% in the Assay and the test for Limit of Maleic Acid and Malic Acid.

2. Add the re-equilibration conditions to Table 1 in the Assay.

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

 The comment period for this revision ends on January 31, 2027. In the absence of any significant adverse comments, it is proposed to implement this revision via an Interim Revision Announcement with an official date of July 1, 2027.

 (EXC1: S. Saladi)

 Case ID—SUB-3166