Lurasidone Hydrochloride Tablets

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BRIEFING

Lurasidone Hydrochloride Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.

The liquid chromatographic procedure in the Assay was validated using the Alltima C18 brand of column with L1 packing. The typical retention time for lurasidone is about 1.1 min.
The liquid chromatographic procedure in the Organic Impurities test was validated using the Kromasil C18 brand of column with L1 packing. The typical retention time for lurasidone is about 28 min.

(SM4: M. Chang)

Correspondence Number—C261596; C296569

USP REFERENCE STANDARDS FOR PURCHASE

USP Lurasidone Hydrochloride RS
USP Lurasidone Related Compound C RS

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