|
Test |
Specification | Result |
| Appearance | white powder | white powder |
| Solubility | Very slightly soluble in water | Complies |
| dentification | Ultraviolet absorption | Complies |
| Infrared absorption | Complies | |
| Water | ≤6.0% | 1.0% |
| Heavy metals | ≤20ppm | <10ppm |
| Residue on ignition | ≤0.1% | 0.04% |
| Related impurities | Nomorethan0.5% compound A | 0.08% |
| No more than 1.5% for total impurities | 0.50% | |
| HPLC assay | 98.0%~102.0% | 99.5% |