| Product Name | Ceftazidime/Sodium Carbonate | |
| Shelf life | 2 years | |
| ITEMS | SPECIFICATION | RESULT |
| [Description] | A white or almost white crystalline powder | Almost white crystalline powder |
| [Identification] |
(l)the retention time of which corresponds to that in the chromatogram of the CRS (2) It produces a white precipitate. |
In accordance with that of CRS
Complies |
| pH | The pH should between 5.0 to 7.5 | 6.8 |
| Loss on drying | NMT13.5% | 12.6% |
| particulate matter | Meet the requirements | Complies |
| Limit of Pyridine | NMT0.4% | 0.02% |
| Bacterial endotoxins | Meet the requirement | Complies |
| Sterility | Meet the requirements | Complies |
| Assay |
The content of Ceftazidime (C22H22N607S2) should not less than 90.0 per cent and not more than 105.0 per cent on the anhydrous and sodium carbonate
free basis The content of sodium carbonate is 8.0%~10.0° |
9.5% |
| Conclusion：According to USP 32, the results meet the requirements. | ||