TEST ITEMS | SPECIFICATION | RESULTS |
Description | : White Crystalline Powder | white powder |
Identification | : Positive | Positive |
Assay | : 97.0~103.0% | 99.31% |
Melting Point | : 172~178°C | 172.0~176.0°C |
Specific Rotation | : +34~ +38°(C=2,in dioxane) | +36.3° |
Loss On Drying | : 1.0%max in vacuum over P2O5 for 4h | 0.26% |
Residual Solvents | : meets the requirements. | Conforms |
Organic Volatile Impurities | : meets the requirements. | Conforms |
Conclusion |
The specification conform with USP30 standard |