Testing Index | Specifications | Conclusion | |
Appearance | White crystalline powder | white crystalline powder | |
Heavy metal(Pb) | ≤0.001% | <0.001% | |
PH-value | 4.0~6.5 | 4.6 | |
Specific rotation [ α ]20D |
-33.5°~-37.0° | -35.9° | |
Residue on ignition | ≤0.25% | 0.06% | |
Loss on drying | ≤0.5% | 0.1% | |
Identity |
Test A (IR) | To comply | Complies |
Test B (TLC) | To comply | Complies | |
Chromatographic purity |
Single impurity | ≤0.25% | 0.10% |
Total impurity | ≤1.0% | 0.24% | |
Assay(On the dried substance) | 98.9%~ 101.5% | 99.9% | |
Bulk density | 0.35g/cm3 | ||
Tapped density | 0.46g/cm3 | ||
Conclusion: The Product Conforms to USP/EP. |