| Powder: | Yes |
|---|---|
| Customized: | Non-Customized |
| Certification: | GMP, HSE, ISO 9001, USP |
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Specifications:
| TEST ITEM | SPECIFICATIONS | |
| Characters | Appearance | White to creamy white powder, odorless or practically odorless |
| Solubility | Slightly soluble in water, freely soluble in 3N HCl. Slightly soluble in methanol, practically insoluble in alcohol, acetone, chloroform and ether. | |
| Identification | A. IR | The spectrum of sample complies with the spectrum obtained with standard |
| B. Assay: RT | Corresponds to the peak obtained with the standard | |
| Specific Rotation | -21.0° - -23.5°, Calculated as the monohydrate | |
| Loss on Drying | 6.9% - 7.9% | |
| Residue on Ignition | Not more than 0.1% | |
| Heavy Metals | Not more than 0.001% | |
| Limit of Methyldopa | Not more than 0.5% | |
| Carbidopa Related Components A | Not more than 0.5% | |
| Any other impurity | Not more than 0.1% | |
| Total impurities | Not more than 1.0% | |
| Residual Solvents | Methanol: ≤3000 ppm | |
| 2-Propanol: ≤5000 ppm | ||
| Trichloromethane: ≤60 ppm | ||
| Benzene: ≤2 ppm | ||
| Toluene: ≤890 ppm | ||
| Cyclohexanone: ≤20ppm | ||
| Assay | 98.0% - 102.0% | |
| Particle Size | NLT90% pass 100 mesh | |
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