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Home » Active Pharmaceuticals Ingredients » Itraconazole BP/EP

Itraconazole BP/EP

Product Name Itraconazole BP/EP/USP
Chemical Name (2R,4S)-rel-1-(butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
CAS Number 84625-61-6
Chemical Formula C35H38Cl2N8O4 
Molecular Mass 705.64 g/mol
Therapeutic Category Antifungal

Specification of Itraconazole :

Test Specification
Description A white or almost white powder.
Solubility Practically insoluble in water, freely soluble in Methylene chloride, sparingly soluble in Tetrahydrofuran, very slightly soluble in alcohol
Identification By IR The infra Red absorption spectrum of the finely ground sample in KBr dispersion compressed into a disc should exhibit maxima only at the same wavelengths as that of similar preparation of Itraconazole Working Standard
Appearance of solution A solution of 2 g in 20ml Methylene chloride should be clear and not more intensely coloured than BY6
Optical Rotation -0.10º to + 0.10º
Related substances HPLC Maximum Single impurity : NMT 0.5%
Total Impurities : NMT 1.25%
Loss on drying NMT 0.5%w/w
Sulphated Ash NMT 0.1%w/w
Assay on dried basis NLT 98.5% and NMT 101.5% w/w

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Itraconazole Powder

NAME OF PRODUCT : Itraconazole Powder
TEST STANDARDS
Chemical Name 2-butan-2-yl-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1,2,4-'triazol-1-yl methyl)-1,3-dioxolan-4-yl]methoxy] phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one
Description A white or almost white powder
Solubility Practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran and very slightly soluble in alcohol.
Identification
a) Melting range

Between 166.0°C and 170.0°C





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