Testing items | Specifications | Results |
Description | White or off-white crystalline powder | Conforms |
Identification | IR and UV absorption | Conforms |
Melting point | 139℃~144℃ | 140.5℃ |
Loss on drying | ≤1.0% | 0.15% |
Residue on ignition | ≤0.20% | 0.07% |
Heavy metals | ≤20ppm | Conforms |
Related substances | Single impurity ≤0.2% | 0.09% |
Sum impurity ≤1.0% | 0.22% | |
Assay | 98.0%~102.0% | 100.10% |
Conclusion: The Product Conforms to CP/USP. |