BRIEFING

 Atazanavir Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this drug product that appeared in PF 42(1) has been canceled and is being replaced with a new proposal.

1. The liquid chromatographic procedure in the Assay is based on analysis performed with the J’ Sphere ODS-H80 brand of column with L1 packing. The typical retention time for atazanavir is about 9 min.

2. The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the YMC-Pack ODS-AQ brand of column with L1 packing. The typical retention time for atazanavir is about 29 min.

 (SM1: S. Shane)

 Case ID—SUB-1911, SUB-1941, SUB-2458