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|
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 |
Conforms |
|
Chlorides |
≤0.02% |
Conforms |
|
Residual solvent |
Methanol ≤0.2% Isopropanol ≤0.2% Ethyl acetate≤0.2% Chloroform ≤0.2% |
0.0% 0.0% 0.0% 0.0% |
|
Related substances (HPLC) |
Single impurity ≤0.2% Total impurities ≤0.5% |
0.05% 0.08% |
|
Assay |
≥99.5% |
99.92% |
