BRIEFING

 Dolutegravir Tablets. 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 in the Assay was validated using the Ascentis Express C18 brand of column with L1 packing. The typical retention time for dolutegravir is about 17 min.

2. The liquid chromatographic procedure in the Dissolution test was validated using the Kinetex C8 brand of column with L7 packing. The typical retention time for dolutegravir is about 2 min.

3. The liquid chromatographic procedure in the Organic Impurities test was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for dolutegravir is about 60 min.

 This monograph is contingent on FDA approval of a product that meets the proposed monograph specifications. Please see the Pending Monograph Guideline for additional information.

 (SM1: R. Radhakrishnan)

 Case ID—SUB-543, SUB-1200