| Items | Standards | Results |
| Appearance | White or off-white solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies |
| Solubility | Soluble in DMF, sparingly soluble in THF, slightly soluble in metha nol and acetoni trile, very sightly soluble in ethanol and dichlor omethane, insoluble in water | Complies |
| Polymorphic Form | Polymorphic form 1 | Complies |
| Melting Point | 211ºC~216ºC | 212.8ºC~214.9ºC |
| Water Content | ≤ 0.50% | 0.10% |
| Heavy Metals | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.20% | 0.09% |
| Related Substance | Any single impurity: ≤0.10% | 0.06% |
| Total Impurities: ≤1.00% | 0.16% |
| Assay (on the anhydrous basis) | 98.0%~102.0% | 99.94% |
| Particle Size | D90: ≤100µm | Complies |
| Reference Standard | In-house Standard |
| Conclusion | The product complied to In-house standard. |
| Storage | Preserve in tight,light-resistant containers in a cool place |
Complaint
