Azithromycin

SKU : AIM001
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CAS number

83905-01-5

molecular formula

C38H72N2O12

standard

USP3226USP3232

Package

25kg/drum
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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