Item

Standard  (USP30)

Results

Appearance

White or almost white powder

White powder

Solubility

Easy to dissolve in the water

Complies

Identification

High-performance liquid chromatograph HPLC

Almost the same

Infrared absorption

Almost the same

Water

3.0% ~5.0%

3.9%

Sulphate

≤0.02%

 ＜0.01%

Chloride

≤0.05%

＜0.02%

Phosphate

18.0% ~20.0%

19.20%

Heavy metals

≤20ppm

＜10ppm

Residue on ignition

≤0.1%

0.02%

Chiral impurity

No more than 1.0%

0.02%

Specific rotation

-18.0° ~-23.0° （C=1，water）

-21.3°

Residual solvents

Isopropanol ≤5000ppm

90ppm

Methanol ≤ 3000ppm

99ppm

Toluene ≤ 890ppm

28ppm

DMF ≤880ppm

34ppm

Acetonitrile ≤410ppm

0ppm

Any individual impurity

≤0.5%

0.06%

Total impurities

≤1.0%

0.16%

HPLC assay

98.0% ~102.0%

99.8%

Conclusion : This product complies with in-house standard