Test Item
Analysis Specification
Result
Description
white crystalline powder
Conforms
Loss on drying
≤0.5%
0.20 %
Sulphated ash
≤0.1%
0.08 %
Heavy metals
≤10ppm
Chlorides
≤0.02%
Residual solvent
Methanol ≤0.2%
Isopropanol ≤0.2%
Ethyl acetate≤0.2%
Chloroform ≤0.2%
0.0%
Related substances
(HPLC)
Single impurity ≤0.2%
Total impurities ≤0.5%
0.05%
0.08%
Assay
≥99.5%
99.92%
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