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Introduction
Function
Specification
Product Name | Cefotaxime Sodium Sterile |
Package | 6kg/tin, 2tins/carton |
Appearance | White to slightly yellow crystal or powder |
Solubility | Freely soluble in water; sparingly soluble in ethanol |
Identification | Infrared-spectrometry:both spectra exhibit similar intensities of absorption at the same wave numbers It responds to the qualitative test of sodium salt The chromatogram of the Assay obtained as directed in the Assay exhibits a major peak for cefotaxime, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay |
Specific rotation | +58°~ +64° |
pH | 4.5~6.5 |
Clarity of solution | Clear |
Clarity of solution | Absorbance : ≤0.20 |
Loss on drying | ≤3.0% |
Particulate matter | ≥10μm, ≤ 3000 ≥25μm, ≤ 300 |
Chromatographic purity | Any individual impurity: ≤1.0% Total impurities:≤3.0% |
Bacterial endotoxins | Not more than 0.025 USP Endotoxin Unit per mg |
Sterility | Should be sterile |
Assay | 916ug/mg~964ug/mg |
Visible foreign matter | Essentially free from |
Labeling | According to normative documentation |