4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-[[(1R,2R)-2-[[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]hexahydro-, monohydrochloride (3aR,4S,7R,7aS)-;
(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione, hydrochloride [367514-88-3]
BRIEFING
Lurasidone Hydrochloride. 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 Kromasil 100-5 C18 brand of column with L1 packing. The typical retention time for lurasidone is about 6.6 min.
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The liquid chromatographic procedure in the test for Limit of Lurasidone Related Compound A was validated using the Kromasil 100-5 C18 brand of column with L1 packing. The typical retention time for lurasidone related compound A is about 6.6 min.
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The liquid chromatographic procedure in the test for Limit of Lurasidone Related Compound B was validated using the Chiralcel OD-H brand of column with L40 packing. The typical retention time for lurasidone related compound B is about 11.5 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Kromasil 100-5 C18 brand of column with L1 packing. The typical retention time for lurasidone is about 28 min.
Description and solubility information: White to off-white solid. Sparingly soluble in methanol; slightly soluble in ethanol; very slightly soluble in water and in acetone. Practically insoluble in 0.1 N hydrochloric acid and in toluene.
(SM4: M. Chang)
Correspondence Number—C266856