| Appearance |
white to almost white powder |
| Solubility |
very soluble in water; soluble in acetonitrile; practically insoluble in hexane |
| Identification |
a) Infrared Absorption b) The retention time of the major peak for levetiracetam from the Sample solution corresponds to that of the levetiracetam S-enantiomer from the System suitability solution, as obtained in the test for Limit of Levetiracetam R-Enantiomer |
| Residue on Ignition | Not More Than 0.1% |
|---|
| Heavy Metals | 20 ppm |
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| Water Determination | Not More Than 0.5% |
|---|
| ASSAY | Not Less Than 98.0% and Not More Than 102.0% |
|---|
| 1)calculated on the anhydrous and solvent-free basis |
