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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.
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.
