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Dasatinib
C22H26ClN7O2S·H2O 506.02
 5-Thiazolecarboxamide-N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-, monohydrate;
 N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl]amino]thiazole-5-carboxamide hydrate [863127-77-9]

BRIEFING

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

  1. 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.

  2. The liquid chromatographic procedure in the Organic Impurities test was validated using the Inertsil ODS3 brand of column with L1 packing. The typical retention time for dasatinib is about 23 min.

 Manufacturers are encouraged to submit their specifications for water determination for other hydrate forms or solvates.

 Description and solubility information: White to off-white powder. Insoluble in water; slightly soluble in ethanol and methanol.

 (SM3: M. Jonnada)

 Case ID—SUB-2173

USP REFERENCE STANDARDS FOR PURCHASE

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