Trade Name: Levofloxacin Hydrochloride
Molecular formula: C18H20FN3O4
CAS No: 138199-71-0
Item | Standard | Result | |||
Identification | A: IR test | Conform | |||
B: UV test | |||||
Description | Yellowish white crystalline powder | Conform | |||
Specific rotation | -1°~+1° | -0.62° | |||
Loss on drying | ≤0.2% | 0.18% | |||
purity Test (HPLC) | |||||
A: Individual impurity | ≤0.3% | 0.19% | |||
B: 9-desfluoro ofloxacin | ≤0.2% | 0.13% | |||
C: total impurity | ≤0.5% | 0.30% | |||
Residue on ignition | ≤0.1% | 0.07% | |||
Heavy Metals | ≤0.001% | less than 0.001% | |||
Arsenic | ≤1ug/g | Conform | |||
Residue Solvents | |||||
A: Methanol | ≤0.005% | less than0.005% | |||
B: Ethanol | ≤0.05% | less than0.05% | |||
Assay | ≥98.5% | 99.16% | |||
Conclusion: | The product above conforms to USP29 |