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Vismodegib
C19H14Cl2N2O3S 421.29
 Benzamide, 2-chloro-N-[4-chloro-3-(2-pyridinyl)phenyl]-4-(methylsulfonyl)-;
 2-Chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide [879085-55-9]

BRIEFING

 Vismodegib. 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 used in the Assay and Organic Impurities test was validated using the Zorbax Eclipse XDB C18 brand of column with L1 packing. The typical retention time for vismodegib is about 8 min.

This proposal has undergone the prospective harmonization process with European Pharmacopeia.

 Description and solubility information: White to light brown solid. Very soluble in simulated intestinal fluid and in water (at pH 1); freely soluble in simulated gastric fluid; practically insoluble in water (at pH 7).

 (SM3: H. Ramanathan)

 Case ID—SUB-1081

USP REFERENCE STANDARDS FOR PURCHASE

USP Vismodegib RS
USP Vismodegib Related Compound A RS
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