Levofloxacin Hydrate (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid hydrate CAS:138199-71-0
Prodcut name | Levofloxacin Hydrate |
CAS No. | 138199-71-0 |
Appearance | Light Yellow Crystalline Powder |
Molecular Formula | C36H42F2N6O9 |
Molecular Weight | 370.38 |
Assay | 99% |
ITEMS | STANDARD | RESULTS |
Appearance | Yellowish crystalline powder (Levofloxacin Hemihydrate) | Yellowish crystalline powder |
Specific optical rotation | -92°- -99° | -97.2° |
Identification IR | IR spectrum of sample conforms to that of reference standard. | complies |
Identification HPLC | The retention time of the major peak in the chromatogram of the sample correspons to that of reference standard. (Levofloxacin Hemihydrate) | complies |
PH of solution | 6.8~7.6 | 7.0 |
Clarity of solution | Clear or its opalescence is not more pronounced than that of reference suspension 1.0 | Clear |
UV absorbance | ≤0.05 | 0.002 |
Water | 2.1%~2.7% | 2.7% |
Impurity A | ≤0.2% | <0.2% |
Impurity B | ≤0.2% | 0.07% |
Impurity C | ≤0.2% | Not found |
Any other impurity | ≤0.1% | 0.05% |
Sum of impurities | ≤0.5% | 0.14% |
R-ofloxacin | ≤0.5% | 0.22% |
Ethanol | ≤0.1% | 0.062% |
DMSO | ≤0.1% | Not found |
Chloroform | ≤0.006% | 0.0057% |
Residue on ignition | ≤0.1% | 0.04% |
Heavy metals | ≤10 ppm | 3ppm |
Assay (on anhydrous basis) | 98.0%~102.0% C18H20FN3O4 Levofloxacin Hemihydrate | 99.5% |
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