Benzamide, N-methyl-2-[[3-[(1E)-2-(2-pyridinyl)ethenyl]-1H-indazol-6-yl]thio]-;
N-Methyl-2-{[3-[(1E)-2-(pyridin-2-yl)ethenyl]-1H-indazol-6-yl]sulfanyl}benzamide [319460-85-0]
BRIEFING
Axitinib. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
The liquid chromatographic procedures in the Assay and test for Organic Impurities were validated using the Kromasil 100-5-C18 brand of column with L1 packing. The typical retention time for axitinib is about 8 min.
This monograph is contingent on FDA approval of a product that meets the proposed monograph specifications. Please see the Pending Monograph Program for additional information.
Description and solubility information: White to light-yellow powder. Soluble in dimethyl sulfoxide.
(SM3: A. Leeks, Jr.)
Case ID—SUB-353
USP REFERENCE STANDARDS FOR PURCHASE
USP Axitinib RSUSP Axitinib Related Compound A RS
USP Axitinib Related Compound B RS