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Product name : Fluconazole
CAS NO: 137234-62-9
Appearance: white powder
Tests |
Acceptance Criteria |
Results |
|
Characters |
white or almost white crystalline powder, no order and bitter. Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride |
Conforms |
|
Identification |
(1) IR: Conforms to the Azithromycin RS spectrum (2) HPLC: The retention time of azithromycin peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay |
Conforms |
|
Specific rotation |
-45°~-49°(Anhydrous subatance 20mg/ml dehydrated alcohol) |
-47° |
|
Crystallinity |
Meets the requirement |
Conforms |
|
PH |
9.0~11.0(2mg/ml methanol-water(1:1)) |
10.1 |
|
Water |
4.0%~5.0% |
4.3% |
|
Residue on Ignition |
≤0.3% |
0.02% |
|
Heavy metals |
≤0.0025% |
less 0.0025% |
|
Related substances (HPLC) |
(1) desosaminylazithromycin |
≤0.3% |
0.02% |
N-demethylazithromycin |
≤0.7% |
0.44% |
|
(2) Any other impurity |
≤1.0% |
0.84% |
|
(3) Total impurity |
≤3.0% |
1.6% |
|
Residual solvents |
Methylene Clloride |
≤600ppm |
Not detected |
Acetone |
≤5000ppm |
1306.5ppm |
|
Assay(HPLC) |
945~1030μg/mg (Anhydrous substance) |
966μg/mg |
|
Conclusion |
Conforms to USP32 specification for Azithromycin |
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
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