BRIEFING

 Fluvoxamine Maleate Extended-Release Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures used in the Assay and in the test for Organic Impurities are based on validation performed with the Hypersil BDS C8 brand of column with L7 packing. The typical retention time for fluvoxamine is about 6 min for the Assay and about 11 min in the test for Organic Impurities.

 (SM4: P. Jagu)

 Case ID—SUB-742