2(1H)-Quinolinone, 7-[4-(4-benzo[b]thien-4-yl-1-piperazinyl)butoxy]-;
7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one [913611-97-9]
BRIEFING
Brexpiprazole. 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 procedures in the Assay and test for Organic Impurities were validated using the InertSustain C18 brand of column with L1 packing. The typical retention time for brexpiprazole is about 17 min.
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The liquid chromatographic procedure in the test for Limit of Brexpiprazole Related Compound A was validated using the TSKgel ODS-100V brand of column with L1 packing. The typical retention time for brexpiprazole related compound A is about 9 min.
Description and solubility information: White to pale yellow crystals or crystalline powder. Freely soluble in glacial acetic acid; sparingly soluble in dimethyl sulfoxide (DMSO); slightly soluble in ethanol and in methanol; very slightly soluble in acetonitrile; and insoluble in water.
(SM4: M. Koleck)
Case ID—SUB-1320