BRIEFING

 Alectinib Capsules. 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 used in the Assay and the test for Organic Impurities are validated using the Sunfire C18 brand of column with L1 packing. The typical retention time for alectinib is about 15 min. The liquid chromatographic procedure used in the Dissolution test is validated using the Sunfire C18 brand of column with L1 packing. The typical retention time for alectinib is about 3 min.

 (SM3: R. Fales)

 Case ID—SUB-597