Analysis | Specifications | Results |
Appearance | White or almost white crystalline powder | Complies |
Identification | IR | Complies |
Loss on drying | ≤2.0% | 0.5% |
Melting Point | 175°Cto 185°C | 180°C |
Specific rotation | +128°±3° | 183°C+127°C |
Chromatographic impurities | ||
A. Single impurity | ≤0.2% | Complies |
B. Total impurities | ≤0.5% | 0.3% |
Assay | 98.0% to 102.0% | 99.2% |
Conclusion: Conform to the Enterprise standard |