|
Item |
Specification |
Result |
|
Appearance |
White to creamy white powder |
Creamy white powder |
|
Solubility |
Meets the requirements |
Conforms |
|
IR |
The spectrum of sample complies with the spectrum obtained with standard |
Conforms |
|
Assay: RT |
Corresponds to the peak obtained with the standard |
Conforms |
|
Specific rotation |
-21°~-23.5° |
-22.5° |
|
Loss on drying |
6.9%-7.9% |
7.2% |
|
Residue on ignition |
≤0.1% |
0.04% |
|
Heavy metals |
≤10ppm |
＜10ppm |
|
Methyldopa |
≤0.5% |
0.18% |
|
Carbidopa related compound A |
≤0.5% |
0.08% |
|
Residual solvents |
Meets the requirements |
Conforms |
|
Assay |
98.0-102.0% |
99.9% |