Test items

Specifications

Results

Appearance

White or off-white crystalline powder

Conforms

Identification

High-performance liquid chromatograph HPLC

The retention time of test sample major peak complies to reference standard

Conforms

Inspection

Water

3.3%～4.4%

3.57%

Residue on ignition

No more than 0.1%

0.05%

Sulphate

No more than 0.02%

Conforms

Chloride

No more than 0.05%

Conforms

Related impurity

Total impurities no more than 1.0%

0.30%

Single impurity no more than 0.5%

Conforms

Ethyl acetate

No more than 0.5%

Conforms

Heavy metals

No more than 20ppm

<10ppm

Assay

          98.0%~102.0%

99.70%