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| TESTS | SPECIFICATION | RESULTS |
|---|---|---|
| Identification | A: IR test B: UV test | Conform |
| Description | White or yellowish crystalline powder | Conform |
| Specific rotation | -10 ~ +10 | 0.2 |
| Loss on drying % | ≤0.2 | 0.18 |
| Purity Test (HPLC) A: Individual impurity(%) B: 9-desfluoro ofloxacin(%) C: total impurity(%) | ≤0.3 ≤0.2 ≤0.5 | 0.21 0.08 0.21 |
| Residue on ignition % | ≤0.1 | 0.06 |
| Heavy Metals % | ≤0.001 | <0.001 |
| Arsenic | ≤1ug/g | Conform |
| Residual Solvents A: Methanol % B: Ethanol % | ≤0.005 ≤0.05 | <0.005 <0.05 |
| Assay % | ≥98.5 | 99.1 |
| Conclusion: Comforms | ||
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