TESTING ITEMS | SPECIFICATIONS | RESULTS |
Characteristics | White or almost white powder | Conforms |
Identification | Positive | Conforms |
PH | 3.5~5.5 | 4.6 |
Specific optical rotation | +280°~+305° | +298° |
Related substances | Any impurity ≤1.0% | 0.25% |
Water | 12.0%~15.0% | 13.6% |
Dimethylaniline | ≤20ppm | <20ppm |
Sulphated ash | ≤0.5% | 0.06% |
Assay | 96.0%~102.0% | 99.1% |
Conclusion: The Product Conforms to USP/EP. |