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Fluconazole

Fluconazole Powder USP

Rs 5,500 / KG

Fluconazole Powder USP
  • Grade Standard: USP
  • Packaging Size: 25Kg
  • Packaging Type: Bag
  • CAS Number: 86386-73-4
  • Grade: Pharma Grade
  • Usage/Application: Fungal and yeast infection
  • Grade Standard: USP
  • Packaging Size: 25Kg
  • Packaging Type: Bag
  • CAS Number: 86386-73-4
  • Grade: Pharma Grade
  • Usage/Application: Fungal and yeast infection
  • Chemical Formula: C13H12F2N6O
  • Molecular weight: 306.271 g/mol
Fluconazole is White or almost white crystalline powder with following specifications.

Product NameFluconazole BP/EP/USP
Chemical Name2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
CAS Number86386-73-4
Chemical FormulaC13H12F2N6O
Molecular Mass306.27 g/mol
Therapeutic CategoryAntifungal

Specification of Fluconazole :

TestSpecification
DescriptionWhite or almost white crystalline powder
SolubilityFreely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene.
Appearance of solution5%w/v Solution in methanol should be clear and colorless
Identification
By IR test

By UV test

Determine by infrared absorption spectrophotometry compare the spectrum with the obtained with fluconzole RS or with the reference spectrum of fluconzole.
When examined in the range 200 nm to 350 nm, a 0.025%w/v solution in methanol shows absorption maxima at about 266nm and 261 nm
Loss on DryingNMT 0.50%
Sulphated ashNMT 0.10%
Iron test20 ppm
Related Compound by HPLC (TEST-1)Impurity A : NMT 0.20%
Impurity about RRT 0.6 : NMT 1.00 %
Related Compound B : NMT 0.10 %
Related Compound C : NMT 0.20 %
Any single maximum
Unknown Impurity : NMT 0.10 %
Total unknown impurities : NMT 0.30 %
Total Impurities : NMT 1.50 %
Assay ( on Anhydrous basis )NLT 98.00% and NMT 102.00%w/w
Residual Solvents
- Methyl Chloride
- Ethyl acetate
- Toluene
- Methanol
- Acetone
- Isopropyl alcohol
- Benzene

NMT 500 ppm
NMT 1000 ppm
NMT 890 ppm
NMT 1000 ppm
NMT 1000 ppm
NMT 1000 ppm
NMT 2 ppm
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Yashica Pharmaceuticals Private Limited