Azithromycin

SKU:AIM001
Description:

ITEMS	LIMIT
Appearance	White or almost white power
Solubility	Practically insoluble in water,freely soluble in ethanol and in methylene chloride.
Identification
A) IR spectrum	Conforms to azithromycin RS
B) Rt HPLC	Conforms to azithromycin RS
Specific rotation	Between -45°and -49°
Crystallinity	Meets the requirements
PH	Between 9.0 and 11.0
Related substances	Desosaminylazithromycin
≤0.3%
N-demethylazithromycin	≤0.7%
Any other individual impurity	≤1.0%
Total impurities	≤0.3%
Water	Between 4.0% and 5.0%
Residue on ignition	Not more than 0.3%
Heavy metals	Not more than 25 ppm
Particle size	>150 μm
Assay	Not less than 945μg and not more than 1030μg of azithromycin (C38H72N2O12) per mg, calculated on the anhydrous basis
Acetone	Not more than 0.5%
Ethanol	Not more than 0.05%

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