Wednesday, August 31, 2011

Azithromycin

Product:Azithromycin
Product:Azithromycin
Appearance:white crystalline powder
Idnetification:
1.infrared absorption
2.HPLC
Specific rotation:-45 ---- -49
Crystal linty:meets the requirement
pH:9---11
Moisture:4.6----5
Related substances:N-demethylazithromycin not more than 0.7%
Desosmnlaylazithromycin not more than 0.3%
Any other impurity not more than 1%
Total not more than 3%
Residue on ignition: not more than 0.3%
Heavy metal: not more than 25ppm
Assay:945--1030ug/mg base on anhydrous substance

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