Dasatinib Tablets

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Dasatinib Tablets

BRIEFING

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

The liquid chromatographic procedure in the Assay was validated using the Zorbax Eclipse XDB-C18 brand of column with L1 packing. The typical retention time for dasatinib is about 6 min.
The liquid chromatographic procedure in the Organic Impurities test was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for dasatinib is about 23 min.

(SM3: M. Jonnada)

Case ID—SUB-2174

USP REFERENCE STANDARDS FOR PURCHASE

USP Dasatinib RS
USP Dasatinib Related Compound A RS
USP Dasatinib Related Compound B RS

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