Azithromycin

Brief Description
CAS No.: 83905-01-5 MF: C38H72N2O12 Place of Origin: Shanghai China (Mainland)
Type: Antidote Grade Standard: Medicine Grade Brand Name: ldint
Model Number: LD20120403 Purity: 99% 
Delivery Terms & Packaging
Packaging Detail:25kg/drum
Delivery Detail:prompt after th order confirm
Specifications
Azithromycin

azithromycin
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spec.

Tests

Acceptance Criteria

Results

Cha

white or almost white crystalline powder, no order and bitter. Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride

Conforms

Identification

(1)   IR: Conforms to the Azithromycin RS spectrum

(2)   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

Specific rotation

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

-47°

Crystallinity

Meets the requirement

Conforms

PH

9.0~11.0(2mg/ml methanol-water(1:1))

10.1

Water

4.0%~5.0%

4.3%

Residue on Ignition

≤0.3%

0.02%

Heavy metals

≤0.0025%

less 0.0025%

Related substances

(HPLC)

(1) desosaminylazithromycin

≤0.3%

0.02%

N-demethylazithromycin

≤0.7%

0.44%

(2) Any other impurity

≤1.0%

0.84%

(3) Total impurity

≤3.0%

1.6%

Residual solvents

Methylene Clloride

≤600ppm

Not detected

Acetone

≤5000ppm

1306.5ppm

Assay(HPLC)

945~1030μg/mg (Anhydrous substance)

966μg/mg

Conclusion

Conforms to USP32 specification for Azithromycin