Azithromycin Azithromycine 83905-01-5
Azithromycin :
Items |
Standard |
---|---|
Appearance |
A white or almost white, crystalline powder. Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride. |
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. |
Specific rotation |
-45°~-49°(Anhydrous substance 20mg/ml dehydrated alcohol) |
Crystallinity |
Meets the requirements |
PH |
9.0~11.0 ( 0.1g /50ml methanol-water (1:1)) |
Water |
4.0%~5.0% |
Residue on Ignition |
≤0.3% |
Heavy metals |
≤0.0025% |
Residual solvents |
(1) Methylene Chloride (2) Acetone |
Assay (HPLC) |
C38H72N2O12 945~1030 μg /mg 945~1030 μg /mg |
Azithromycin :
Items |
Standard |
---|---|
Appearance |
A white or almost white, crystalline powder. Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride. |
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. |
Specific rotation |
-45°~-49°(Anhydrous substance 20mg/ml dehydrated alcohol) |
Crystallinity |
Meets the requirements |
PH |
9.0~11.0 ( 0.1g /50ml methanol-water (1:1)) |
Water |
4.0%~5.0% |
Residue on Ignition |
≤0.3% |
Heavy metals |
≤0.0025% |
Residual solvents |
(1) Methylene Chloride (2) Acetone |
Assay (HPLC) |
C38H72N2O12 945~1030 μg /mg 945~1030 μg /mg |
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