Product name | CEFTIZOXIME | |
Shelf life | 3 years | |
ITEM | SPECIFICATION | RESULTS |
Identification |
(1)The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for Ceftizoxime,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay. (2)It responds to the tests for Sodium. |
Conform |
Crystallinity | Meets the requirements. | Conform |
Acidity(PH) | 6.0~8.0 | 7.4 |
Water | No more than 8.5% | 6.8% |
Acetone | No more than 0.5% | 0.13% |
Bacterial Endotoxins | ≥25μ m ≤600/g | Conform |
Sterility | It meets the requirements when tested as directed for Membrane Filtration under test Sterility of the product to be Examined. | Conform |
Assay | 85.0% to 99.5% of Ceftizoxime (C13H12N5O5S2) | 94.3% |
Conclusion:Conforms to USP34 |