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Metformin Hydrochloride
| ITEMS | LIMIT |
| [Characters] | |
| Appearance | White crystal |
| Solubility | Freely soluble water slightly soluble in alchol,practically insoluble in acetone and in methylene chlorlde |
| [Identification] | Complies with reference spectrum |
| A:IR-spectrum B:Identification test | It meets the requirements of the test for chloride |
| [test] | 222-226℃ |
| Melting point | |
| [Related compounds] | |
| Cyanogunadine(imp.A) | ≤0.02% |
| Any other imp. | ≤0.1% |
| Total imp. | ≤0.5% |
| Heavy metals | ≤0.001% |
| Loss on drying | ≤0.5%(dry it at 105℃ for 5 h ) |
| Residue on ignition | ≤0.1% |
| Residual Solvent | |
| Ethanol | ≤0.5% |
| Isoamyol | ≤0.5% |
| Assay | 98.5—101.0% |
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