Topiramate manufacturer CAS:97240-79-4
Sep 10th, 2022 at 00:47 Other Chemicals Drexel Heights 50 views Reference: OpnelOk6dKB
Location: Drexel Heights
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Synonyms：
| Items of Analysis | Test Results | Results |
| Appearance | White to off-white powder | White powder |
| Solubility | Freely soluble in dichloromethane | Conform |
| Identification | Infrared Absorption | Conform |
| The retention time of the major peak of the sample solution corresponds to that of the Standard solution, as obtained in the Assay | Conform | |
| Specific rotation | Between -28.6°and -35.0°，measured at 20° | -31.1° |
| Water | ≤0.5% | 0.16% |
| Residue on ignition | ≤0.2% | 0.07% |
| Heavy metals | ≤10ppm | Conform |
| Related compounds by HPLC | Fructose not more than 0.3% | No detected |
| Compound A not more than 0.3% | 0.13% | |
| Other individual impurity not more than 0.1% | 0.08% | |
| Total impurities not more than 0.5% | 0.27% | |
| Sulfamate and sulfate | Sulfamate ion not more than 0.10% | No detected |
| Sulfate ion not more than 0.10% | No detected | |
| 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. | 99.4% |
| Residual solvent | 1,2-dichloroethanenot more than 5ppm | No detected |
| Pyridine not more than 100ppm | 12ppm | |
| Ethanol not more than 1000ppm | 581ppm | |
| MIBK not more than 1000ppm | 13ppm | |
| Acetone not more than 1000ppm | 7ppm | |
| Conclusion | The material complies with respect to USP38 | |
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