BRIEFING

 Cabazitaxel Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. The liquid chromatographic procedure used in the Assay and Organic Impurities test was validated using the Symmetry C18 brand of column with L1 packing. The typical retention time for cabazitaxel is about 19 min.

 This proposal has been partially retroactively aligned with cabazitaxel acetone concentrate for infusion from European Pharmacopoeia 11.4.

 (SM3: M. Jonnada)

 Case ID—SUB-1686, SUB-1688