BRIEFING

 Testosterone Topical Gel. 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(6) [Nov.–Dec. 2015] was canceled and is replaced with a new proposal.

1. The liquid chromatographic procedure in the Assay was validated using the Nucleosil C18 brand of column with L1 packing. The typical retention time for testosterone is about 7.5 min.

2. The liquid chromatographic procedure in the test for Organic Impurities was validated using the YMC-Pack ODS-AQ brand of column with L1 packing and the Phenomenex Security Standard C18 brand of guard column with L1 packing. The typical retention time for testosterone is about 13 min.

 (SM5: M. Chang)

 Case ID—SUB-1135; SUB-1137; SUB-1138; SUB-1139