TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White to off-white, odorless crystalline powder | Confirms |
Solubility | Slightly soluble in water, freely soluble in 3N HCL, insoluble in ethanol. | Confirms |
Identification | IR: The sample comparing with the spectrum obtained with standard | Confirms |
RT: The chromatogram RT of sample comparing with the obtained of levodopa standard | Confirms | |
Specific rotation | -160°~-167° | -162.5° |
Loss on drying | ≤0.50% | 0.44% |
Residue on ignition | ≤0.10% | 0.05% |
Related compounds | Levodopa related compound A≤0.10% | Undetected |
L-Tyrosine ≤0.10% | Undetected | |
Levodopa related compound B≤0.50% | 0.01% | |
L-Veratrylglycine ≤0.10% | Undetected | |
Unknown impurities ≤0.10% | 0.02% | |
Total impurities ≤1.10% | 0.13% | |
Residual solvents | Methanol ≤3000ppm | Below LOD |
Assay | 98.0% ~102.0% | 99.1% |
Conclusion: The Product Conforms to USP. |