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