BRIEFING

 Ciclopirox Shampoo. 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.

 Stakeholders are encouraged to submit FDA's approved specifications for the USP Expert Committee's consideration.

 (SM1: R. Nguyen)

 Case ID—SUB-635