BRIEFING
Brexpiprazole Tablets. Because there is no existing USP monograph for this drug product, 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 TSKgel ODS-80Ts brand of column with L1 packing. The typical retention time for brexpiprazole is about 3 min.
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The liquid chromatographic procedure in the test for Dissolution was validated using the TSKgel ODS-80Ts brand of column with L1 packing. The typical retention time for brexpiprazole is about 3 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Capcell Pak C18 AQ brand of column with L1 packing. The typical retention time for brexpiprazole is about 14 min.
(SM4: M. Koleck)
Case ID—SUB-1321