BRIEFING

 Ciclopirox 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 liquid chromatographic procedures in the Assay and the test for Organic Impurities were validated using the Zorbax SB-CN brand of column with L10 packing. The typical retention time for ciclopirox is about 11 min.

 (SM1: R. Nguyen)

 Case ID—SUB-1523