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Fluconazole

Human API

Characterised impurities

ImpurityChemical namePharmacopoeia
Impurity “F”(2RS)-2-(2,4-difluoro phenyl)-3-(1H-1,2,4- triazol-1-yl)propane- 1,2-diol (Diol)EP/BP
"Epoxide" impurity / Impurity "G"1-[[(2RS)-2-(2,4- Difluorophenyl)oxira n-2-yl)methyl]-1H- 1,2-TriazoleIHT
TDA1H-1,2,4-Triazolyl Difluoro AcetophenoneIHT
Impurity “C”3-[{[2- [diaminomethyliden e)amino] thiazol-4- yl]methyl} sulfanyl]- sulfamolypropanamiIHT
Impurity “D”3-[[[2- [(diaminomethyllide ne)amino] thiazol-4- yl]methyl ]sulfanyl]propanamiEP/USP
Impurity “E”2,2’[disulfanediylbis( methylene thiazol- 4,2-diyl)diguanidineEP/USP

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