CAS number: 63527-52-6
Molecular formula: C16H17N5O7S2
molecular weight: 455.46500
Chemical structure:
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 |