BRIEFING

 Teriflunomide. This proposal is based on the version of the monograph to be official on January 1, 2026. On the basis of comments received, it is proposed to revise the acceptance criterion for leflunomide related compound A from NMT 0.01% to NMT 107 ppm in the test for Organic Impurities to accommodate FDA approved specifications. In addition, the following changes are proposed:

• Add a separate equation for calculating the content, in ppm, of leflunomide related compound A.

• Replace the numerical reporting threshold in the Acceptance criteria section with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

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

 The comment period for this revision ends September 30, 2025. In the absence of significant adverse comments, it is proposed to implement this revision via an Interim Revision Announcement with an official date of January 1, 2026.

 (SM4: S. Dragan)

 Case ID—SUB-1746