Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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Audited by an independent third-party inspection agency
Items |
Standard |
Result |
appearance |
A white crystalline powder; odorless | Qualified |
Solubility |
Very slightly soluble in water; very soluble in ch'loroform ; freely soluble in ethanol and a'cetone |
Qualified |
Specific rotation |
+4.5° ~ +6.5° |
+5.4° |
Thin layer chromatography; |
The test solution to reveal the host spot location and color control solution and artesunate agreement under sunlight |
Qualified |
HPLC |
Obtained with the test solution is similar to that of the principal peak in the chromatogram obtained with reference solution |
Qualified |
Infrared Atlas |
The infrared absorption spectrum should be consistent with the control |
Qualified |
acidity |
3.5~4.5 |
4.2 |
Clarification and color of solution |
should clear the colorless, If it is cloudy, Not more thicker than No. 1 turbidity standard solution |
Qualified |
chloride |
Not more thicker than the control solution(not exceeding 0.02%) |
Qualified |
Dihydroartemisinin |
≤1.0% |
N.A |
Artsesunate |
≤0.5% |
N.A |
impurity |
≤0.2% |
0.08% |
Other single miscellaneous |
≤0.2% |
0.05% |
Total impurity |
≤2.0% |
0.14% |
water |
≤0.5% |
0.24& |
Burning residue |
≤0.1% |
0.07% |
heavy metal |
≤20ppm |
Qualified |
Bacterial endotoxin |
≤1.25EU |
Qualified |
Content(HPLC) |
98%~102.0% |
98.3% |
Conclusion |
The products complies with standard CP2015 |