| Product name | Cefdinir | ||
| Shelf life | 2 years | ||
| Test items | Enterprise specification | Test results | Conclusion |
| Character | Slight yellow to yellow crystalline powder, with slight smelly | Slight yellow crystalline powder, with slight smelly | Conform |
| Identification |
1. In the chromatogram of the assay, the retention time of the principal peak in the chromatogram obtained with the test solution should correspond to that of the principal peak in the chromatogram obtained with reference solution. 2. The IR absorption spectrum of the substance to be examined should correspond to that of the reference spectrum(No.l 122). |
1. In the chromatogram of the assay, the retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that of the principal peak in the chromatogram obtained with reference solution. 2. The IR absorption spectrum of the substance to be examined corresponds to that of the reference spectrum(No.l 122). |
Conform |
| Specific rotation | -58一-66° | -62° | Conform |
| Absorption coefficient | 571一-610° | 583 | Conform |
| Crystallinity | It gives phenomenon of birefringence and extinction direction. | It gives phenomenon of birefringence and extinction direction. | Conform |
| pH | 2.5 〜4.5 | 3.4 | Conform |
| Water | No more than 2.0% | 1.1% | Conform |
| Conclusion: | The test results of substance examined conform to the Specification of Cefdinir | ||