| Identification | Infrared Absorption |
| The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation , as obtained in the Assay | |
| Specific rotation | Between -28.6° and -35.0°,measured at 20° |
| Water | Not more than 0.5% |
| Residue on Ignition | Not more than 0.1% |
| Heavy metals | Not more than 10ppm |
| Related compounds by HPLC (Test 1) |
Fructose not more than 0.3% Compound A not more than 0.3% Other individual impurity not more than 0.1% Total impurities not more than 0.5% |
| Limit of sulfamate and sulfate | Sulfamate ion not more than 0.10%; Sulfate ion not more than 0.10%. |
| Assay | Topiramate contains not less than 98.0% and not more than the equivalent of 102.0% of C12H21NO8S, calculated with reference to the Anhydrous Basis. |
