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Topiramate
| ITEMS | LIMIT |
| Appearance | White crystalline powder |
| Melting Point | 1220C～1260C |
| Rotation Degree | -28.60～-350 |
| Identification | HPLC |
| Shall comply with approved tests | |
| IR | |
| Concordant with the reference standard | |
| Water | ≤0.5% |
| Residue on ignition | ≤0.2% |
| Heavy metals | ≤10ppm |
| Related Compound(TLC) | Total impurities |
| ≤0.5% | |
| Individual impurities | |
| ≤0.3% | |
| Related Compound(HPLC) | Total impurities |
| ≤0.5% | |
| Compound A | |
| ≤0.3% | |
| Other Individual impurities | |
| ≤0.1% | |
| Limit of sulfamate and sulfate | ≤0.1% |
| N-hexane | Max 290μ/g |
| Ethyl acetate | Max 2500μ/g |
| Pyridine | Max 100μ/g |
| Total bacterial | Max 100UFC/g |
| Fungus and/or yeast | Max 10UFC/g |
| Pathogens Search | E. coil |
| P. aeruginosa | |
| S. aureus | |
| Salmonella | |
| Assay | 98.0-102.0% |
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