Azithromycin Pharma Grade EU10/USP43
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Appearance |
White or almost white crystalline powder |
Conforms |
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Solubility |
Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride |
Conforms |
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Identification |
IR:Conforms to the Azithromycin RS |
Conforms |
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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 |
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Specific rotation |
-45°~-49° |
-47.4° |
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Appearance of solution |
Clear and colourless(0.5g/50mg anhydrous ethanol) |
Conforms |
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Crystallinity |
Meets the requirements |
Conforms |
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pH |
9.0~11.0(2mg/mg methanol-water(1:1)) |
10.1 |
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Water |
4.0%~5.0% |
4.3% |
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Residue on ignition |
≤0.2% |
＜0.01% |
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Related substances |
Impurity A ≤0.5% |
＜0.05% |
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Impurity B ≤0.5% |
0.48% |
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Impurity C ≤0.5% |
0.11% |
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Sum of Impurities D, J & Q ≤0.3% |
0.13% |
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Impurity D ≤0.15% |
N.D |
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Impurity E ≤0.5% |
N.D |
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Impurity F ≤0.5% |
0.07% |
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Impurity G ≤0.2% |
N.D |
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Impurity I ≤0.5% |
N.D |
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Impurity H ≤0.5% |
N.D |
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Impurity L ≤0.5% |
N.D |
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Impurity M ≤0.5% |
＜0.05% |
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Impurity N ≤0.5% |
N.D |
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Impurity O ≤0.5% |
0.1% |
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Impurity P ≤0.2% |
0.08% |
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Erythromycin A iminoether ≤0.5% |
N.D |
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Erythromycin A oxime ≤0.5% |
N.D |
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Any other impurity ≤0.2% |
0.09% |
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Total impurities ≤3.0% |
1.1% |
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Assay |
960-1020ug/mg |
979ug/mg |