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Fluconazole

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Fluconazole

CAS number: 86386-73-4

Molecular formula:C13H12F2N6O

Molecular weight: 306.27

Packing: 25kg/drum

Shelf Life: 2 years

Specification:

Items

Specification

Result

Description

White or almost white crystalline powder. Odourless or less special odor

Complies

 

 

Solubility

Freely solute in methanol;soluble in alcohol and in acetone;sparingly soluble in isopropanol and in chloroform; slightly soluble in water;very slightly soluble in toluene

 

 

Complies

Melting Point

137-141℃

138-140℃

Chromatographic

identification

The retention time of the main peak of the test solution should be consistent with the retention time of the main peak of reference

sample.

 

Complies

 

Uv spectrum identification.

From 261nm to 267nm wavelength has the maximum absorption, at the 264nm wavelength has the minimum absorption

 

Complies

Infra-red identification

The infrared absorption spectra of this product should be consistent with reference spectrum (opp 893).

 

Complies

Appearance of solution

The solution should be clarified;The solution are not more opalescent < I than reference suspension I if there is turbid

 

Complies

 

Relate Substance

Any impurity ≤0.4%

0.09%

Total impurity ≤0.4%

0.16%


Chlorinated Compounds

 

The sample solition compare with reference solution ≤0.3%

 

Complies

Loss on drying

≤0.4%

0.20%

Ignition residue

≤0.1%

0.04%

Heavy Metal

≤20PPM

Complies

 

 

 

residual solvent

Alcohol ≤0.5%

0.04%

Aether ≤0.5%

Did not detected

 Ethyl Acetate≤0.5%

0.006%

Cyclohexane≤0.388%

Did not detected

Assay

Not less than 99.0% of C13H12F2N6O, calculated on the dried

99.70%

Aerobe

≤103cfu/g

<1*10cfu/g

Yeast and Mold

≤102cfu/g

<1*10cfu/g

Escherichia coli

Could not detectable

Did not detected

 

Conclusion

 

The above product conforms to CP2015 and in-house specification(STP-ZL107)

 

 

Function&Application

1. Fluconazole is indicated in the treatment of febrile neutropenia when fungal infections are suspected or proven. 
2. Fluconazole is indicated in nonimmunocompromised patients for the treatment of onychomycosis caused by tinea unguium, Trichophyton species and Candida species. 
3. Fluconazole is indicated for the treatment and suppression of cryptococcal meningitis. 
4. Fluconazole is indicated in the treatment of pulmonary and disseminated coccidioidomycosis caused by Coccidioides immitis.
5. Fluconazole is indicated in the treatment of vulvovaginal candidiasis caused by Candida species. 
6. Fluconazole is indicated for the treatment of serious infections, including peritonitis, pneumonia, and urinary tract infections, caused by susceptible Candida species. 
7. Fluconazole is also indicated for the treatment of systemic infections caused by Candida species in neonates. 
8. Fluconazole is indicated for the treatment of esophageal and oropharyngeal candidiasis (thrush) caused by Candida species.
9. Fluconazole is indicated for the prophylaxis of candidiasis in patients undergoing bone marrow transplant who receive cytotoxic chemotherapy and/or radiation therapy.

 


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