BRIEFING

 Frovatriptan 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 41(5) was canceled and is replaced with a new proposal.

 The liquid chromatographic procedures in the Assay, Dissolution test, and the test for Organic Impurities are validated using the Inertsil C8-3 brand of column with L7 packing. The typical retention time for frovatriptan is about 6 min for the Assay and Dissolution test, and about 24 min for the Organic Impurities test.

 (SM4: H. Ramanathan)

 Case ID—SUB-1035, SUB-2698, SUB-2700