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Cefradine
| ITEMS | LIMIT |
Appearance Solubility | White to off-white, crystalline powder. Sparingly soluble in water, very slightly soluble in alcohol and in chloroform, practically insoluble in ether. |
| Identification | The IR spectrum confirm to that of reference standard |
| Crystallinity | Meet the requirements |
| PH | 3.5 to 6.0 |
| Specific optical rotation | +80.0° to +90.0° |
| Water | Not more than 4.3% |
| Limit of Cephalexin | Not more than 5.0% |
| Related substance | |
| 7-ADCA | NMT 1.0% |
| Any other impurity | NMT 2.0% |
| Total | NMT 2.5% |
| N,N-Dimethylaniline | Not more than 20 ppm |
| Acetone | NMT 0.3% |
| Dichloromethane | NMT 0.06% |
| Sulphated ash | NMT 0.2% |
| Assay | 99.0% to 105.0% |
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