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Voriconazole is used to treat serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esophageal candidiasis (candida esophagitis), or other fungal infections (infections in the skin, stomach, kidney, bladder, or wounds). It may also be used to treat patients with serious fungal or yeast infections who cannot tolerate other types of treatment or do not respond to other types of treatment.
Specification:
|
Test Item |
Analysis Specification |
Result |
|
Description |
White to off white crystalline powder |
Conforms |
|
Melting range |
129°C~132°C |
130.8°C-131°C |
|
Loss on drying |
≤0.5% |
0.20 % |
|
Specific rotation |
-58°~-62°(C=1,in CH3OH) |
-61.05° |
|
Sulphated ash |
≤0.1% |
0.08 % |
|
Heavy metals |
≤10ppm |
Conforms |
|
Chlorides |
≤0.02% |
Conforms |
|
Sulfates |
≤0.02% |
Conforms |
|
Fluorine |
14.7%~17.9% |
15.2% |
|
Residual solvent |
Methanol ≤0.2% Isopropanol ≤0.2% Ethyl acetate≤0.2% Chloroform ≤0.2% |
0.0% 0.0% 0.0% 0.0% |
|
Related substances (HPLC) |
Single impurity ≤0.2% Total impurities ≤0.5% |
0.05% 0.08% |
|
Assay |
≥99.5% |
99.92% |
|
Conclusion |
Accordance with the reference |
|
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
