| Item | Specification | Results | |
| Character | Appearance | White to off-white crystalline powder | Conforms |
| Conforms | |||
| Identification | IR | The IR absorption spectrum of sample must exhibit maxima at the same wavelength as the of reference standard. | Conforms |
| HPLC | The retention time of major peak in test solution obtained in the test of Related substances by HPLC should correspond to that of the system suitability solution | Conforms | |
| Water content (by KF) | ≤ 0.5% | 0. 08 % | |
| Chloride | ≤ 0. 0 5% | Conforms | |
| Sulfate | ≤ 0.05% | Conforms | |
| Residue on Ignition | ≤ 0. 1 % | 0.0 6 % | |
| Related substances | Impurity 9090-403≤0.3% | 0.03% | |
| Impurity 9090-3≤0.3% | ND | ||
| Any individual unspecified impurity ≤0.10% | 0.05% | ||
| Total impurities≤1.0% | 0.11% | ||
| Assay (HPLC) | 98.0% ~ 102.0%(on anhydrous basis) | 99. 7 % | |
| Conclusion | Conform to In-house standard. | ||
|
The End |