BRIEFING

 Dapagliflozin Propanediol. This proposal is based on the version of the monograph official as of December 1, 2023. On the basis of comments received, a revision to the relative standard deviation criteria in the Content of Propanediol test to reflect the peak area ratio of propanediol to ethylene glycol from 6 injections is needed. In addition, the following revisions to the Organic Impurities test are proposed:

1. Add a table and Note to the System suitability section to present relative retention times as an aid in peak assignment.

2. Relocate the relative retention time information for dapagliflozin related compound A to the table in the System suitability section.

3. Revise the table in the Acceptance criteria to list only the limits for the specified impurity, any unspecified impurity, and total impurities.

4. Under the Acceptance criteria, the numerical reporting threshold has been replaced with a reference to general chapter User-Determined Reporting Thresholds 〈477〉 for user flexibility. For more information about this change, please see the USP Compendial Notice “ New Chapter 〈477〉 User-Determined Reporting Thresholds and its Implementation in USP–NF Monographs.”

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

 The comment period for this revision ends on Sep 30, 2025. 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 January 1, 2026.

 (SM3: R. Fales)

 Case ID—SUB-1849