Fluconazole

CAS number: 86386-73-4

Molecular formula: C13H12F2N6O

molecular weight: 306.27

Chemical structure:

SR.NOTESTSPECIFICATIONRESULTS
1.DescriptionA white or almost white crystalline powderWhite crystalline powder
2.Identification

By IRIR absorption spectrum of the test sample should be concordant with IR spectrum obtained from working standardComplies

By UVThe UV absorption spectra obtained from 
200 ug/ml test solution andworking standard 
solution should exhibit maxima at same wavelength
Complies
3.Clarity and colour of solution5% w/v solution in Methanol should be clear and colourlesscomplies
4.Related substance by HPLC

Impurity ANMT 0.20%0.01%

Impurity about RRT 0.6NMT 1.0%0.14%

Impurity BNMT 0.1%Not detected

Impurity CNMT 0.2%Not detected

Any other individual impurityNMT 0.1%0.04%

Total unknown impuritiesNMT 0.3%0.09%

Total impuritiesNMT 1.50%0.25%
5.IronNMT 20 PPMLess than 20 PPM
6.Residue on ignitionNMT 0.1% W/W0.02% W/W
7.Loss on DryingNMT 0.5% W/W0.27% W/W
8.Assay (on dried basis)NLT 98.0% and NMT 102.0%99.65%