Items

Specifications

Results

Appearance

White or almost white,hygroscopic powder

White hygroscopic powder

Identification A:IR

The IR spectrum of the sample corresponds to the spectrum of reference standard

Conforms

Solubility

Practically in water,freely soluble in isopropyl alcohol,soluble in acetone and methylene chloride,sparingly soluble in methanol

Conforms

Water

≤7.0%

3.3%

Heavy metals

≤20ppm

＜20ppm

Sulfated ash

≤0.1%

0.03%

Related Substances

Impurity A≤2.0%

0.09%

Impurity B≤2.0%

0.12%

Impurity C≤1.5%

0.07%

Impurity D≤1.5%

ND

Any unknown impurity≤0.2%

0.16%

Total impurity≤4.0%

0.53%

Residual solvents

Acetone≤5000ppm

ND

Acetonitrile≤410ppm

2ppm

Dichloromethane≤600ppm

77ppm

Isopropanol≤5000ppm

15ppm

Mehtanol≤3000ppm

ND

Toluene≤890ppm

ND

Assay

96.0-102.0%(on anhydrous basis)

100.5%

Conclusion

The product conforms to above standard.