ITEM | STANDARD | RESULTS |
Appearance | White crystalline powder | Conforms |
Assay, % | 98.0~101.0 | 99.9 |
Loss on drying, % | ≤1.0 | 0.05 |
PH | 7.0~9.8 | 7.7 |
Heavy metals, ppm | ≤20 | 19 |
Enantiomeric purity, % | ≤2.5 | 0.3 |
Identification | ||
Specific optical rotation, 째C | -14.7~-17.0 | -15.7 |
Infrared absorption | Meet the requirements | Conform |
Reaction of sodium | Meet the requirements | Conform |
Related substances | ||
Impurity L, % | ≤0.1 | <0.1 |
Unspecified impurities, % | ≤0.1 | 0.03max |
Total, % | ≤0.3 | 0.04 |
Appearance of solution | Clear, not more intense than BY7 | Conform |