5-Thiazolecarboxylic acid, 2-[3-cyano-4-(2-methylpropoxy)phenyl]-4-methyl-;
2-[3-Cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid [144060-53-7]
BRIEFING
Febuxostat. 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 the Organic Impurities test are based on validations performed with the YMC-Pack Phenyl brand of column with L11 packing. The typical retention time for febuxostat is about 8.6 min in the Assay and 22.4 min in the Organic Impurities test.
Description and solubility information: White to off-white crystalline powder. Freely soluble in dimethylformamide; soluble in dimethyl sulfoxide; practically insoluble in water.
(SM2: W. Yang)
Case ID—SUB-630, SUB-656, SUB-671
USP REFERENCE STANDARDS FOR PURCHASE
USP Febuxostat RSUSP Febuxostat Related Compound C RS
USP Febuxostat Related Compound D RS
USP Febuxostat Related Compound E RS