| Product Name | Cefotaxime Sodium | |
| Shelf life | 2 years | |
| Test items | Standard | Test results |
|
Description |
White,off-white to pale yellow crystalline powder,ordorless,or slight special ordor | White,crystalline powder slight special ordor |
| Clarity and color solution |
1.The solution is clear 2.Absorbance≤0.20 |
Conforms 0.08 |
| Identification |
1.IR spectrum is concordant with RS |
Conforms |
|
2.The retention time of the principal peak in HPLC Chromatogram is identical with RS |
Conforms | |
| 3.It responds to the tests for sodium | Conforms | |
| Specific optical rotation | +58.0o-+64.0o | +60.0o |
| pH | 4.5-6.5 | 5.6 |
| Loss on drying | ≤3.0% | 2.1% |
|
Chromatogram purtiy Individual impurity Total impurities |
≤1.0% ≤3.0% |
0.41% 1.68% |
| Sterility | Conforms | Conforms |
| Bacterial endotoxins | ≤0.20EU/mg | Conforms |
| Visible particles | ≤0.20EU/mg | Conforms |
| Particulate matter |
≥10μm: ≤2000pc/g ≥25μm: ≤200pc/g |
330pc/g 30pc/g |
| Residue solvent | Conforms | Conforms |
| Bulk Density | ≥0.45g/ml | 0.47g/ml |
| Tapped Density | ≥0.65g/ml | 0.68g/ml |
| Assay | It contains the equivalent of not less than 916μg/mg and not more than 964μg/mg of cefotaxime,C16H17N5O7S2 calculated on the anhydrate basis. | 943μg/mg |
| CONCLUSION:THE RESULTS CONFORM WITH USP 35 STANDARD | ||