BRIEFING

 Desvenlafaxine Succinate. This proposal is based on the version of the monograph official as of October 1, 2020. On the basis of comments received, it is proposed to correct the relative response factors in the test for Organic Impurities. Additionally, it is proposed to revise the monograph with the following changes:

1. In the test for Organic Impurities:

   • Add a temperature storage requirement for the Sample solution based on the solution stability validation data.

   • Add Table 2 and a note in the System suitability section to present relative retention times as an aid in peak assignment.

   • Update the footnote for succinic acid and the trivial name for 4-[2-(Dimethylamino)ethyl]phenol.

   • In Table 3, list only the limits for specified impurities, any unspecified impurity, and total impurities.

   • Under the Acceptance criteria, the numerical reporting threshold has been replaced with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

2. Add a temperature requirement in the Packaging and Storage section on the basis of comments received.

 The current standard lacks an acceptance criterion for Water Determination 〈921〉 related to the anhydrous form of Desvenlafaxine Succinate. Manufacturers utilizing desvenlafaxine succinate (anhydrous) are encouraged to submit their FDA-approved specifications for the expert committee's consideration.

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

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

 (SM4: Y. Yang)

 Case ID—SUB-654