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Fluconazole

Fluconazole

a-(2,4-Difluorophenyl)-a-(1H-1,2,4-triazol-1-yl-methyl)-1H-1,2,4-triazole-1-ethanol

C13H12F2N6O
Mol. Wt.: 306.27
CAS 86386-73-4
 
Description
White or off-white crystalline powder

Medical Use/Therapeutic Category
Antifungal (topical and oral)
 
Solubility
- Freely soluble in methanol
- Soluble in chloroform or ethanol
- Slightly soluble in water
 
Identification
A. Infrared spectrum:  Conforms to that of the Reference Standard  
B. Ultraviolet absorption spectrum:  Exhibits two maxima at 261 and 266 nm
 (0.025 % w/v solution in methanol in the range of  200-350 nm)


Characteristics of a 5 % W/V solution
Appearance:  Clear and free of particles

pH
Between 5.5 and 7.0 (0.3% w/v of aqueous solution)

Chromatographic Purity (related substances)
Any unknown compound:  Not more than 0.2 %
Total impurities:  Not more than 1.0 %

Assay
98.0 – 102.0 % (on anhydrous basis)

Other Tests
Melting range:  136˚-141˚C
Residue on ignition:  Not more than 0.1%
Water content:  Not more than 0.5%

Specifications and Analytical Methods – available upon request

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