COA
Certification Of Analysis
Items
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Specifications
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Results
|
Appearance
|
White powder
|
White powder
|
Identification (by IR)
|
Conforms to the GRS spectrum
|
+91.4°
|
Loss on drying
|
≤0.5%
|
0.2%
|
Sulphated ash
|
≤0.1%
|
0.09%
|
Assay(by HPLC)
|
97.0%~103.0%
|
99.7%
|
Related substances (by HPLC)
|
Any individual impurity ≤1.5%
|
0.28%
|
Total impurities≤ 2.0%
|
0.62%
|
Residual solvents
|
Ethanol≤5000ppm
Methylene chloride ≤600ppm
Hexane ≤290ppm
Dioxane ≤380ppm
Pyridine ≤200ppm
|
69ppm
43ppm
Undetected (LOD 3ppm)
Undetected(LOD 8pppm)
Undetected (LOD 4ppm)
|
Conclusion: meet the specification according to USP31.
|