TEST | SPECIFICATION | RESULT |
Character | White or grayish yellow powder,odor free and humidifying | Conform |
Identification | 1. In the chromatogram of the assay, the retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that of the principal peak in the chromatogram obtained with reference solution 2. It gives flame reaction of sodium salt | Conform |
Water | Not more than 3.0% | 0.71% |
Acidity(pH) | 5.5~7.5 | 6.2 |
Color of solution | No more intensity colored than reference solution Yedllow 9 or Orange-yellow 9 | Less intensely colored than reference solution Yellow 8 |
Clarity of solution | No more pronounced than that of reference suspension I | Less pronounced than that of reference suspension I |
Assay (Ceftiofur sodium) | No less than 98.0%(anhydrous and acetone free) | 98.8% |
Related substances | Biggest individual impurity | No more than 0.5% | 0.1% |
Total | No more than 3.0% | 0.98% |
Residual solvents | Acetone: no more than 2.0% | 1.0% |
Particulate matter | ≥10μm:no more than 5000 particles/g | 597 particles/g |
≥25μm:no more than 500 particles/g | 27 particles/g |
Bacterial endotoxin | No more than 0.2EU/mg (Ceftiofur) | Less than 0.20EU/mg(Ceftiofur) |
Sterility | No growth of micro-organisms should occur after 14 days of incubation | No growth of micro-organisms should occur after 14 days of incubation |
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