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Leflunomide

Human API

Characterised impurities

ImpurityChemical namePharmacopoeia
Impurity “B”(2Z)-2-Cyano-3- hydroxy-N- [4(Trifluoromethyl) phenyl]but-2- enamideBP/US P
Impurity “C”5-Methyl-N-[3- (trifluoromethyl)phe nyl]-4- isoxazolecarboxamidBP/US P
Leo ester half cyclizedEthyl 6,7,8-trifluoro- 1,4-dihydro-1-((S)-1- hydroxy propan-2- yl)-4-oxo-quinoline- 3-carboxylate; half cycle ester Ethyl (S,Z)-3-((1-IHT

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