2H-Pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide, N-[(2,4-difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-, sodium salt (1:1), (4R,12aS)-;
Sodium (4R,12aS)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate [1051375-19-9]
BRIEFING
Dolutegravir Sodium. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the Kinetex Phenyl-Hexyl brand of column with L11 packing. The typical retention time for dolutegravir is about 12 min.
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The liquid chromatographic procedure in the Organic Impurities, Procedure 1 test was validated using the Kinetex Phenyl-Hexyl brand of column with L11 packing. The typical retention time for dolutegravir is about 23 min.
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The liquid chromatographic procedure in the Organic Impurities, Procedure 2 test was validated using the Kinetex F5 brand of column with L43 packing. The typical retention time for dolutegravir is about 35 min.
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The liquid chromatographic procedure in the Stereoisomeric Purity test was validated using the Chiralpak IF-3 brand of column with L134 packing. The typical retention time for dolutegravir is about 31 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.
Description and solubility information: White to pale-yellow powder. Very slightly soluble in methanol; practically insoluble in absolute alcohol, in 2-propanol, and in acetonitrile.
(SM1: R. Radhakrishnan)
Case ID—SUB-317, SUB-1201