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| Test Items | Specification | Test Results |
|---|---|---|
| Appearance | white or almost white crystalline powder, slightly smelly | white crystalline powder |
| Melting point | 123~127°C | 123~125°C |
| Specific Rotation | +28°~+30° | +29° |
| Acidity(PH) | 5.2~6.5 | 5.8~6.2 |
| Water | 4.0%~5.5% | 0.05 |
| Residue On Ignition | Not more than 0.1% | Conforms |
| N.N - dimethylaniline | Comply with the standard | Conforms |
| Phenolic Compounds | Comply with the standard | Conforms |
| Related Substance | Comply with the standard | Conforms |
| Assay | Between99.0~102.0% | 0.9953 |
| Conclusion | This batch is complies with USP 34. | |