Test Item

Analysis Specification

Result

Description

White or almost white crystalline powder, No odor and bitter. Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride.

Conforms

Identification

A: IR: Conforms to the Azithromycin RS spectrum

B: 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

Conforms

Specific rotation

-45°~-49°(Anhydrous substance 20mg/ml dehydrated alcohol)

-47°

Crystallinity

Meets the requirements

Conforms

pH

9.0~11.0 ( 0.1g /50ml methanol-water (1:1))

10.0

Water

4.0%~5.0%

4.4%

Residue on Ignition

≤0.3%

0.02%

Heavy metals

≤0.0025%

<0.0025%

Residual solvents

Methylene Chloride≤600ppm

Acetone≤5000ppm

Not detected

1159.0ppm

Assay((HPLC)

945~1030 μg /mg ( Anhydrous substance)

965μg /mg

Conclusion

Conform to USP 26 Standard