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| Item | Standard | Result |
| Appearance | A white or almost white powder | Almost white powder |
| Identification | A: HPLC, retention time of main peak corresponds to that of reference standard
B: IR, IR spectrum of sample corresponds to that of reference standard | Complies |
| Melting point | 174-178°C | 174-175°C |
| Loss on drying | ≤1.0% | 0.60% |
| Residue on ignition | ≤0.2% | 0.14% |
| Related substances | N-Methyl derivatives≤0.5%
Other single impurity≤0.2% Total impurities≤1.0% | 0.31%
0.12% (RRT=0.542) 0.16% (RRT=1.996) 0.08% (RRT=1.454) 0.7% |
| Assay (on dried basis) | 98.0-101.0% | 98.5% |
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