BRIEFING

 Tacrolimus Ointment. 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 43(3) [May–June 2017] was canceled and is replaced with a new proposal. The liquid chromatographic procedure for the Assay and the test for Organic Impurities is based on analyses performed with the Kinetex C18 brand of column with L1 packing. The typical retention time for tacrolimus is about 31 min.

 (SM1: S. Shane)

 Case ID—SUB-1714