BRIEFING

 Sitagliptin Tablets. This proposal is based on the version of the monograph official as of Aug. 1, 2022. On the basis of comments received, a revision to the test for Organic Impurities is necessary to update the relative retention times and relative response factors for sitagliptin styrylacetyl analog and sitagliptin phenylcrotonyl analog to reflect the correct elution order of these impurities. Additionally, it is proposed to revise the monograph with the following changes:

1. Revise the Suitability requirements for Relative standard deviation in the Assay from NMT 2.0% to NMT 1.0% to be consistent with the expectations for modern chromatographic systems.

2. The following additional updates to the test for Organic Impurities are proposed:

   • Updated the chemical name for impurity fumarate adduct to N-succinyl sitagliptin.

   • Add a table and Note in the System suitability section within the test to present relative retention times as an aid in peak assignment. Revise the table in the Acceptance criteria section to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.

   • Revise the Acceptance criteria to clarify that the limits for unspecified and total impurities should be for any unspecified degradation product and total degradation products, respectively, for the drug product within the test for Organic Impurities.

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

 The comment period for this revision ends November 30, 2023. In the absence of significant adverse comments, it is proposed to implement this revision via an Interim Revision Announcement with an official date of March 1, 2024.

 (SM3: R. Fales)

 Correspondence Number—C322973