BRIEFING

 Desvenlafaxine Extended-Release Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this drug product, which appeared in PF 44(1) [Jan.–Feb. 2018], has been canceled and is being replaced with a new proposal. All sections of the proposal have been updated based on information from manufacturers of FDA-approved drug products.

1. The liquid chromatographic procedure used in the proposed Assay, Procedure 1, for products labeled to contain desvenlafaxine, was validated using the Inertsil Ph-3 brand of column with L11 packing. The typical retention time for desvenlafaxine is about 4 min.

2. The liquid chromatographic procedure used in the proposed Assay, Procedure 2, for products labeled to contain desvenlafaxine succinate equivalent to desvenlafaxine, was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for desvenlafaxine is about 4 min.

3. The liquid chromatographic procedure used in the proposed Dissolution Test 2, for products labeled to contain desvenlafaxine succinate equivalent to desvenlafaxine, was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for desvenlafaxine is about 2.6 min.

4. The liquid chromatographic procedure used in the proposed Dissolution Test 3, for products labeled to contain desvenlafaxine succinate equivalent to desvenlafaxine, was validated using the Xbridge BEH Phenyl brand of column with L11 packing. The typical retention time for desvenlafaxine is about 3.8 min.

5. The liquid chromatographic procedure used in the proposed Dissolution Test 4, for products labeled to contain desvenlafaxine succinate equivalent to desvenlafaxine, was validated using the Zorbax Eclipse XDB-C8 brand of column with L7 packing. The typical retention time for desvenlafaxine is about 3.5 min.

6. The liquid chromatographic procedure used in the proposed test for Organic Impurities, Procedure 1, for products labeled to contain desvenlafaxine, was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for desvenlafaxine is about 8 min.

7. The liquid chromatographic procedure used in the proposed test for Organic Impurities, Procedure 2, for products labeled to contain desvenlafaxine succinate equivalent to desvenlafaxine, was validated using the Zorbax SB-CN brand of column with L10 packing. The typical retention time for desvenlafaxine is about 26.0 min.

 (SM4: Y. Yang)

 Case ID—SUB-1493