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Capecitabine
| ITEMS | LIMIT |
| Appearance | A white or off white crystalline powder |
| Solubility | Freely soluble in chloroform and in methanol |
| Identification | |
| a) IR | IR chromatograph Conforms to the characteristic peak of R.S. |
| b) HPLC | The retention time of the major peak in the chromatogram Conforms to the characteristic peak of R.S. |
| Water | Not more than 0.3% |
| Specific optical rotation | +96.0°~+100.0° |
| Residue on ignition | Not more than 0.1% |
| Heavy metals | Not more than 20 ppm |
| Related substance | |
| Impurity A: | Not more than 0.15% |
| ImpurityB: | Not more than 0.15% |
| ImpurityC: | Not more than 0.15% |
| Unspecified impurity | Not more than 0.10% |
| Total impurities | Not more than 1.0% |
| Assay[on dried basis,by HPLC] | 98.0% to 102.0% |
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