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Items | Standards | Results |
Appearance | A white to off white crystalline powder | off white crystalline powder |
Melting point | 172~179ºC | 174.0~175.0ºC |
Related Substances(HPLC) | Max.single impurity:£0.1% | Max.single impurity:0.04% |
Total impurity:£1.0% | Total impurity:0.04% | |
Water | Not more than 0.5% | 0.40% |
Residue on ignition | ≤0.1% | 0.05% |
Heavy metals | ≤20ppm | Corresponds |
Residual Solvents | ||
-Methanol | Not more than 0.3% | N.D. |
-Acetone | Not more than 0.05% | N.D. |
-Toluene | Not more than 0.089% | N.D. |
-Dichloromethane | Not more than 0.06% | N.D. |
-Ethyl acetate | Not more than 0.5% | 0.07% |
-DMF | Not more than 0.109% | 0.03% |
Assay | 98.0~102.0% | 99.60% |