Ofloxacin is a fluoroquinolone antibiotic considered to be a second-generation fluoroquinolone.
|
Item |
Standard (USP27) |
Test Result |
|
Appearance |
White or yellow light crystalline powder |
Complies |
|
Identification |
A: IR test |
Complies |
|
B: UV test |
Complies |
|
|
Optical rotation |
-1°~ +1° |
+0.16° |
|
Specific Solvents,A: Methanol |
≤0.005% |
＜0.005% |
|
Specific Solvents,B: Ethanol |
≤0.05% |
＜0.005% |
|
Purity test（HPLC),A: Individual impurity |
≤0.3% |
0.20% |
|
Purity test（HPLC),B: 9-desfluoroofloxacin |
≤0.2% |
0.11% |
|
Purity test（HPLC),C: Total impurity |
≤0.5% |
0.45% |
|
Loss on drying |
≤0.2% |
0.15% |
|
Residue on ignition |
≤0.1% |
0.05% |
|
Heavy metals |
≤0.001% |
＜0.001% |
|
Arsenic |
≤1μg/g |
Conform |
|
Assay |
≥98.5% |
99.30% |