BRIEFING

 Ketoconazole Cream. 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 in the Assay and Organic Impurities test are based on validations performed with the Luna C18(2) brand of column with L1 packing. The typical retention time for ketoconazole is about 8 min.

 (SM1: M. Fadadu)

 Case ID—SUB-2343