Varieties: | Other |
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Component: | Chemical Synthetic Drugs |
Type: | Other |
Pharmacodynamic Influential Factors: | Other |
Storage Method: | Prevent Exceeding Quality Guarantee Period |
Veterinary Reg. No.: | Other |
Customization: |
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ITEMS | SPECIFICATIONS | RESULTS |
Appearance | A White or almost white crystalline powder | Conforms |
Solubility | Practically insoluble in water,freely soluble in anhydrous ethanol and in methylene chloride |
Conforms |
Identification | IR | Conforms |
HPLC | ||
Crystallinity | Meet the requirements | Conforms |
PH | 9.0 ~ 11.0 | 9.9 |
Related substances | Desosaminylazithromycin ≤0.3% | DL |
N-demethylazithromycin ≤0.7% | 0.001 | |
Any other single impurity ≤1.0% | Conforms | |
Total impurities≤3.0 % | 0.015 | |
Residual solvents | Acetone ≤0.5% | 0.003 |
Loss on drying | 4.0 % ~ 5.0% | 0.045 |
Residue on Ignition | ≤0.3% | 0.0004 |
Melting point | 50 °C ~ 60 °C | 50 °C ~ 60 °C |
Sulphate ash | ≤0.1% | 0.0005 |
Heavy metals | ≤ 25 ppm | NMT25 ppm |
Assay ( calculated on the anhydrous basis) |
945 ug ~ 103 ug of azithromycin per mg | 982 ug/ mg |
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