Levetiracetam Levetiracetam Levetiracetam
USP/EP
Levetiracetam
Appearance |
White or almost-white powder |
Identification |
IR spectrum accordance with that of CRS |
Solubility |
Very soluble in water,soluble in acetonitrile,practically insoluble in hexane |
Appearance of solution |
Colourless and clear |
Specific optical rotation |
-76°~ -82° |
Water |
≤0.5% |
Sulfated ash |
≤0.1% |
Heavy metals |
≤0.001% |
Related substance |
Impurity A≤0.3% Impurity B≤0.05% Any unspecified impurity≤0.05% Total unspecified impurities≤0.1% Total impurities ≤0.4% |
Impurity C |
≤0.025% |
Impurity D |
≤0..8% |
Residual solvents |
Ethanol≤5000ppm Methanol≤3000ppm Dichloromethane≤600ppm Ethy acetate≤5000ppm Acetone ≤5000ppm |
Assay |
98.0%~102.0% |
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