Tests

Specification

Results

Characters

Appearance

White or almost white powder

White powder

Solubility

Practically insoluble in water ,freely soluble in anhydrous ethanol and 

Conforms

Identification

IR: Conforms to the spectrum of Azithromycin R.S

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°

-48°

Crystallinity

Meets the requirements

Conforms

pH

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

9.8

Water

4.0% ~ 5.0%

4.6%

Residue on ignition

≤0.3%

<0.01%

Heavy Metals

≤25ppm

<25ppm

Related substance (HPLC Test 2)

Impurity A

≤0.5%

<0.10%

Impurity B

≤1.0%

0.51%

Impurity C

≤0.5%

0.23%

Impurity J

≤0.3%

0.14%

Impurity E

≤0.5%

Not detected

Impurity F

≤0.5%

<0.10%

Impurity G

≤0.5%

<0.10%

Impurity I

≤0.7%

Not detected

Impurity L

≤0.5%

Not detected

Impurity M

≤0.5%

Not detected

Impurity N

≤0.5%

Not detected

Impurity O

≤0.5%

<0.10%

Impurity P

≤0.2%

<0.10%

Total impurities

≤3.0%

0.88%