Items | Specifications |
Appearance | White to off-white crystal powder |
Identification | IR: similar to the reference standard |
Melting point | 248-268℃ |
Solubility | Soluble in propylene glycol, sparingly soluble in methanol. Slightly soluble in water. Practically insoluble in chloroform, in acetone, in ethyl acetate and in hexane. |
Residue on ignition | ≤0.5% |
Elemental impurities | ≤20ppm |
Loss on drying | ≤0.5% |
Organic volatile impurities | Meet the requirements |
Residual solvents | Methanol≤3000ppm |
Ethanol≤5000ppm | |
Ethyl acetate≤5000ppm | |
Total impurities | ≤1.5% |
Assay(HPLC) | 97~103% |