BRIEFING

 Trimipramine Capsules. 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 46(3) [May–Jun. 2020] has been canceled and is being replaced with this new proposal.

 The liquid chromatographic procedure used in the Assay and the test for Organic Impurities was validated using the Acquity UPLC BEH C18 brand of column with L1 packing. The typical retention time for trimipramine is about 4 min.

 (SM4: P. Jagu)

 Correspondence Number—C194287