BRIEFING

 Vismodegib Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

1. The liquid chromatographic procedure used in the Assay and Organic Impurities test was validated using the Zorbax Eclipse XDB C18 brand of column with L1 packing. The typical retention time for vismodegib is about 8 min.

 This proposal has undergone the prospective harmonization process with European Pharmacopeia.

 (SM3: H. Ramanathan)

 Case ID—SUB-1118