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Cefotaxime Sodium
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Item: | Spec. | Result: |
Description | Off-white to pale yellow crystalline powder | White crystalline powder |
Solubility | Freely soluble in water, practically insoluble in organic solvents | Complies |
Clarity and color of solution | ||
Absorbance(430nm) | Not more than 0.20 | 0.12 |
Clarity | The solution is clear | Complies |
Color of solution | The solution is clear | Complies |
Identification | (A) IR spectrum matches with RS | Complies |
(B) The retention time of principal peak in HPLC chromatogram is the same with RS | Complies | |
(C) Yields the flame reaction of sodium salts | Complies | |
Specific rotation | +580~+640 | +620 |
PH | 4.6~6.5 | 5.2 |
Loss on drying | Not more than 3.0% | 2.4% |
Chromatographic purity | ||
Individual impurity | Not more than 1.0% | 0.3% |
Total impurities | Not more than 3.0% | 2.0% |
Bacterial endotoxins | Not more than 0.20EU/mg | Complies |
Sterility | Complies | Complies |
Assay | 916ug/mg~964ug/mg | 933ug/mg |
Cefotaxime Sodium