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Levofloxacin hemihydrate

CAS No:138199-71-0
Shelf life:4 years
The detailed specifications are as below:

AppearanceLight yellowish-white to yellow-white crystals or crystalline powder
Soecific rotation-92°~-106°
IdentificationA:Infrared Absorption

B:The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the assay.

Residue on ignition≤0.2%
Related substances

(HPLC 1)

N-Desmethyl levofloxacin:≤0.3%

Diamine derivative:≤0.3%

Levofloxacin N-oxide:≤0.3%

9-Desfluoro levofloxacin:≤0.3%


Any unknown impurity:≤0.1%

Total impurities:≤0.5%

Related substances

(HPLC 2)

Levofloxacin related compound A:≤0.20%

Levofloxacin related compound B:≤0.13%

Any other impurity:≤0.10%

Total impurities:≤0.50%

Assay (Anhydrous basis)98.0%~102.0%