| PRODUCT NAME | ||
| TEST ITEMS | SPECIFICATION | RESULTS |
| Description | White Or Almost White Crystalline Powder | White Powder |
| Identification | Infrared Absorption | Positive |
| Assay | 97.0~103.0% | 99.2% |
| Melting Point | 33~37ºC | 34.5~36.5ºC |
| Loss On Drying | 0.5%max | 0.30% |
| Organic Volatile Impurities | 2500PPm max | <1000PPm |
| Residual Solvents | Meet the requirements.(USP29) | Confirms |
| Chromatographic purity | sum of impurities:3.0%max | <3.0% |
| Conclusion | The specification conform with USP32 standard | |