COA:
Test Items | Specification | Test Results |
Identification | TLC | Positive |
UV spectrum | Positive | |
IR spectrum | Positive | |
Characteristics | White to almost white crystalline powder | Conform |
Melting point | 162~168℃ | 152~166℃ |
Specific optical rotation | +79°~ +85° | +82.5° |
Loss on drying | ≤2.0% | 1.1% |
Assay | 97~103% | 99.08% |
Related substances | ≤1.0% | Pass |
Residual solvents(GC) | Acetone ≤100ppm | Pass |
Methanol ≤100ppm | Pass | |
Pyridine ≤100ppm | Pass | |
Conclusion |
This batch is complies with USP31 |