Test Items | Specification | Test Results |
Appearance | White or off-white powder | confirm |
Identification | A、R、C in Pass | confirm |
Melting point | 41~46 degree | 42~43.5 degree |
Chromatographic purity | In Pass | confirm |
Related substance | Not more than the reference solution 0.05% | confirm |
Heavy metals | ≤10ppm | confirm |
Residue on ignition | ≤0.10% | 0.03% |
Loss on Drying | ≤ 0.5% | 0.18% |
Assay | 98.0 -101.0% | 99.60% |
Conclusion | Confirms USP 32 |