BRIEFING

 Vortioxetine Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

1. The liquid chromatographic procedures in the Assay and the test for Dissolution were validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for vortioxetine is about 3 min.

2. The liquid chromatographic procedure in the test for Organic Impurities was validated using the YMC-Triart C18 brand of column with L1 packing. The typical retention time for vortioxetine is about 27 min.

 This monograph is contingent on FDA approval of a product that meets the proposed monograph specifications. Please see the Pending Monograph Guideline for additional information.

 (SM4: D. Singh)

 Case ID—SUB-1062