Test Items | Specification | Test Results |
Appearance | White powder | White powder |
Melting point | 125~127°C | Conforms |
Specific Rotation | +28°~+30° | +29° |
Acidity( | 5.2~6.5 | 5.8~6.2 |
Water | 4.0%~5.5% | 5.0% |
Residue On Ignition | Not more than 0.1% | Conforms |
N.N â dimethylani | Comply with the standard | Conforms |
nolic Compounds | Comply with the standard | Conforms |
Related Substance | Comply with the standard | Conforms |
Assay | Between99.0~102.0% | 99.53% |
Conclusion | This batch is complies with USP 41 |
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