Benzamide, N-[4-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl]-3-methylphenyl]-2-methyl;
N-[4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl]-2-methylbenzamide [150683-30-0]
BRIEFING
Tolvaptan. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedure in the Assay is based on validation performed with the Zorbax SB C8 brand of column with L7 packing. The typical retention time for tolvaptan is about 9 min.
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The liquid chromatographic procedure in the test for Organic Impurities is based on validation performed with the Zorbax SB C8 brand of column with L7 packing. The typical retention time for tolvaptan is about 39 min.
Description and Solubility information: White to off-white powder. Freely soluble in N,N-dimethyl formamide; sparingly soluble in methanol; slightly soluble in dichloromethane; practically insoluble in water.
(SM2: R. Ivaturi)
Case ID—SUB-1228