Fluconazole

SKU : AIF002
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CAS number

86386-73-4

molecular formula

C13H12F2N6O

standard

BP2010/USP32/EP6

Package

25kg/drum
ITEMS LIMIT
Appearance White crystalline powder
Solubility(1gr in 10ml Methanol) Slightly soluble in methanol.
Appearance of Solution Clear and Colourless
Identification by IR The Spectrum should be Concordant with reference standard solution.
Melting range 138.0°C TO 142.0°C
Loss On Drying (At 105°C) Not more than 0.50%
Heavy Metals Not more than 20 PPM.
Sulphated Ash Not more than 0.20%
Assay Between 99.0% 101.0%
Related Substances (By HPLC)
Single Impurity NMT 0.50%
Total Impurities NMT 1.00%
Iron Content NMT 0.002%
Chloride Content NMT 0.30%
Fluoride Content Between 11.0% to 12.4%
Residual Solvent Ethyl Acetate NMT 5000 PPM

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