| Customization: | Available |
|---|---|
| Usage Mode: | For oral administration |
| Suitable for: | Adult |
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Items | Specifications | Results |
Appearance | White to off-white, crystalline powder. | Off-white powder |
Solubility | Sparingly soluble in water, very slightly soluble in alcohol and in chloroform, practically insoluble in ether. | Complies |
Identification | The IR spectrum confirm to that of reference standard. | Complies |
Crystallinity | Meet the requirements | Complies |
pH | 3.5 to 6.0 | 5.0 |
Water | Not more than 6.0% | 3.6% |
Limit of Cephalexin | Not more than 5.0% | 1.3% |
Related substance | ||
7-ADCA | NMT 1.0% | Not found |
Any other impurity | NMT 2.0% | 1.3% |
Total | NMT 2.5% | 1.4% |
N,N-Dimethylformamide | NMT 0.088% | Not found |
Acetone | NMT 0.3% | 0.004% |
Dichloromethane | NMT 0.06% | 0.003% |
Assay | 90.0% to 105.0% | 99.2% |
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