Powder: | Yes |
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Certification: | GMP, HSE, ISO 9001, USP, BP |
Suitable for: | Elderly, Children, Adult |
State: | Solid |
Purity: | >99% |
Purity Degree: | 99% |
Customization: |
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Items |
Standard |
Result |
Appearance | White to creamy white powder | Creamy white powder |
Solubility | Slightly soluble in water,freely soluble in 3 N hydrochloric acid;Slightly soluble in methanol;Practically insoluble in alcohol, in acetone,in chloroform,and in ether. |
Complies |
Identification | IR:The spectrum of sample complies with the spectrum obtained with standard. | Complies |
RT:Corresponds to peak obtained with the standard. | Corresponds | |
Specific rotation | -21°~ -23.5° | -21.8° |
Loss on drying | 6.9%-7.9% | 7.2% |
Residue on ignition | 0.1% max | 0.02% |
Heavy metals | 0.001% max | 0.001% max |
Methyldopa | 0.5% max | 0.3% max |
Carbidopa related compound A |
0.5% max | Undetected |
Any other impurity | 0.10% max | 0.06% |
Total impurities | 0.10% max | 0.44% |
Residual solvents | Meets the requirements | Complies |
Assay | 98.0%-102.0% | 99.8% |
Conclusion | The batch complies with the USP 37 specification. |
Items |
Standard |
Result |
Appearance |
White to off-white powder |
White powder |
Assay (W/W dry basis) |
≥98.0% |
99.16 % |
Residue on ignition |
<0.5% |
0.256% |
Water (w/w by KF) |
≤1.0% |
0.420% |
pH Value(1% aq.) |
5~9 |
7.28 |
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