Customization: | Available |
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Transport Package: | Box and Carton |
Specification: | 1.0g *10vials |
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Audited by an independent third-party inspection agency
Testing terms | Standards | Results |
Clarity of solution | Clarified | Clarified |
Particulate matter | Not detected | Not detected |
Sub-visible particles | ≥10um,≤6000Particles/Bottle ≥25um,≤600Particles/Bottle |
107.7 Particles/Bottle 10.9 Particles/Bottle |
Acidity | 4.5~6.5 | 5.51 |
Loss on drying | ≤3.0% | 1.60% |
Single impurity | ≤6.0% | 0.44% |
Total of impurities | ≤10.0% | 1.44% |
Bacterial endotoxins | Not more than 0.20EU per mg of cefotaxime. | <0.20EU/mg |
Uniformity of dosage units |
AV≤15.0 | 6.16 |
Sterility | Complies | Complies |
Assay | 90.0%-115.0% | 98.27% |