
Item | Specification |
Appearance | White or almost white crystalline powder |
Melting point | 242.0-246.0℃ |
Identification | Retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation obtained as specified in the assay. |
IR spectra is consistent with CRS. | |
Appearance of solution | Clear and colorless |
Fluorides | ≥11.0% |
Related substances | Individual impurity≤1.0% |
Total impurities≤2.0% | |
Loss on drying | ≤0.5% |
Residue on ignition | ≤0.1% |
Heavy metals | ≤10ppm |
Assay | 98.0%~102.0% on dried substance |