TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White or off-white powder | Confirms |
Identification | Meets the requirements | Confirms |
Melting point | 250℃~265℃ | 260.1℃ |
Optical rotation | +20.0°~+22.0° | +21.0° |
Loss on drying | ≤0.10% | 0.05% |
Heavy metals | ≤10ppm | <10ppm |
Single impurity | ≤0.15% | 0.01% |
PH | 7.5~8.5 | 7.9 |
Assay | 99.0%~101.0% | 99.60% |
Conclusion: The Product Conforms to USP. |