CAS number: 115550-35-1
Molecular formula: C17H19FN4O4
molecular weight: 362.3556
Chemical structure:
Name of Product: | Marbofloxacin | |
Shelf Life: | 5 years | |
Specification: | EP8 | |
Test Items | Specification | Results of Analysis |
Appearance | Light yellow crystalline powder | Conforms |
Solubility | Slightly soluble in water, sparingly soluble or slightly soluble in methylene chloride, very slightly soluble in ethanol (96 percent) | Conforms |
Identification | Conforms to the marbofloxacin CRS | Conforms |
Absorbance | ≤0.20 | 0.08 |
Loss on drying | ≤0.5% | 0.12% |
Sulphated ash | ≤0.1% | 0.05% |
Heavy metals | ≤20ppm | <20ppm |
Related substance (HPLC) | Impurity A≤0.1% | Not detected |
Impurity B≤0.1% | Not detected | |
Impurity C≤0.2% | 0.06% | |
Impurity D≤0.2% | Not detected | |
Impurity E≤0.2% | Not detected | |
Any other single impurity≤0.2% | Not detected | |
Total impurities≤0.5% | 0.06% | |
Residual solvents | ethanol≤5000ppm | 309ppm |
toluene≤890ppm | 457ppm | |
methylene chloride≤600ppm | Not detected | |
Assay | 99.0% to 101.0% (dried substance) | 100% |