BRIEFING
Tolvaptan Tablets. Because there is no existing USP monograph for this drug product, 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 Dissolution is based on validation performed with the Xterra RP18 brand of column with L1 packing. The typical retention time for tolvaptan is about 4 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 31 min.
(SM2: R. Ivaturi)
Case ID—SUB-1299