Description
Product Specifications:
Appearance:-A white crystalline powder, odourless, almost tasteless
Solubility:- Freely soluble in ethanol, in acetone and in chloroform; very slightly soluble in water.
Melting point:- 132~136?
Specific optical rotation:- +4.5°~ +6.5°(c=25mg/ml Dichloromethane)
Liquid chromatogram:- The retention time of the principal peak of the substance being examined in the chromatogram obtained in the Assay is identical with that of artesunate CRS in the chromatogram of the reference solution.
IR:- Should be concordant with the reference spectrum
Acidity:- 3.5~5.0
Clarity and colour of solution:- Should comply with the specification
Chloride:- Should comply with the specification
Related substances:-
Total impurities:- NMT2.0%
Any individual impurity:- NMT 0.5%, and impurity detected between 0.5%~1.0% should not more than one.
Water:- NMT0.5%
Residue on ignition: – NMT0.1%
Heavy metals: – NMT0.002%
Assay:-98.0%~102.0%
Conclusion: – Conclusion
Identification: – HPLC IR
