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Items | Standard | Results |
Description | White crystalline powder | Complies |
Identification | IR HPLC Reactive | Conform with standard IR Conform with standard HPLC Conform |
Solubility | Freely soluble in me thanol,ace tone,ethanol and tetrahydro fu ran.And very soluble in ace tonitrile | Complies |
Total Impurity | max.0.5% | 0.18% |
Total Unspecified Impurity | max. 0.2% | 0.08% |
Individual unspecified impurlty | max. 0.1% | 0.05% |
Related compound B | max. 0.2% | 0.07% |
Related compound C | max. 0.2% | 0.04% |
Related compound D | max. 0.1% | 0.05% |
Related compound E | max. 0.1% | 0.06% |
Limit of cyclo he xane | max. 0.08% | ND |
Limit of ethylacetate | max. 0.1% | 0.07% |
Melting point | 81.0~84.0ºC | 82.5~83.2ºC |
Water | max. 0.3% | 0.21% |
Residue on ignition | max. 0.1% | 0.07% |
Heavy Metals | max.0.001% | Complies |
Assay(HPLC) | 98.0%~102.0% | 99.8% |
Storage | Cool and dry | |
Conclusion | It complies to USP32 . |