Shanghai Upbio Tech Co.,Ltd
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Ms.NancyCAS NO.177325-13-2
99%(1-100)Kilogram
Bulk Levofloxacin Hemihydrate
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CHARACTERS |
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Light yellowish-white to yellow-white crystals or crystalline powder |
Light yellow-white crystalline powder |
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IDENTIFICATION |
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IR |
The spectrum obtained from sample consists with that obtained from Levofloxacin RS |
Complies |
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HPLC |
The reaction time of major peak of the Sample solution corresponds to that the Stanard solution,as obtained in the Assay |
Complies |
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Assay(on the anhydrous basis) |
98.5%~102.0% of C18H20FN3O4 |
98.8% |
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IMPURITIES |
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Residue on ignition |
Not more than 0.2% |
0.04% |
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Heavy metals |
Not more than 10ppm |
Less than 10ppm |
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Organic impurities |
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N-Desmethyl levofloxacin |
Not more than 0.3% |
0.03% |
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Diamine derivative |
Not more than 0.3% |
0.01% |
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Levofloxacin N-oxide |
Not more than 0.3% |
Not found |
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9-Desfluoro levofloxacin |
Not more than 0.3% |
Not found |
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D-Isomer |
Not more than 0.8% |
0.20% |
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Any unknown impurity |
Not more than 0.1% |
0.07% |
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Total impurities(except the D-isomer) |
Not more than 0.5% |
0.25% |
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Optical rotation(at 20°C) |
-92°~ -106° |
-98.3° |
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Water |
2.1%~2.7% |
2.7% |
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Residue solvents |
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Chloroform |
Not more than 60ppm |
40ppm |
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Ethanol |
Not more than 1000ppm |
464ppm |
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DMSO |
Not more than 1000ppm |
Not found |
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CONCLUSION |
The result conform with the specification |
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