BRIEFING

 Venlafaxine 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(6) [Nov.–Dec. 2018] has been canceled and is being replaced with a new proposal. The new proposal includes changes to the Identification, Organic Impurities test, and USP Reference Standards section. The detector in the Assay is revised accordingly to include the information to run Identification B.

1. The liquid chromatographic procedures in the Assay and Dissolution test were validated using the Hypersil BDS C8 brand of column with L7 packing. The typical retention time for venlafaxine is about 8 min.

2. The liquid chromatographic procedure in the Organic Impurities test was validated using the Kinetex EVO C18 brand of column with L1 packing. The typical retention time for venlafaxine is about 23 min.

 (SM4: H. Ramanathan)

 Case ID—SUB-445