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
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
Acetonitrile≤410ppm
2ppm
Dichloromethane≤600ppm
77ppm
Isopropanol≤5000ppm
15ppm
Mehtanol≤3000ppm
Toluene≤890ppm
Assay
96.0-102.0%(on anhydrous basis)
100.5%
Conclusion
The product conforms to above standard.
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