Item | Specification |
Appearance | White or almost white crystalline powder |
Identification | IR, HPLC |
Melting point | 152℃~156℃ |
Specific optical rotation | -16°~ -19° |
PH | 4.5~6.5 |
Water | ≤0.5% |
Residue on ignition | ≤0.1% |
Heavy metals | ≤20ppm |
Chlorides | ≤0.02% |
Fluorides | ≥4.8% |
Related substances | Individual impurity ≤0.5% |
Total impurities ≤2.0% | |
Assay | ≥98.0% |