NaturChem Barcelona

Levofloxacin Hemihydrate

Appearance Pale-yellow crystalline powder
Identification IR IR: the infrared absorption spectum of the substances obtained on discs with potassium bromide in the range from 4000 cm-1 to 400 cm-1 should comply with that of levofloxacin reference standard with respect to the positioning of the absorption bands.
Identification UV The ultraviolet absorption spectrum of 0.0006% solucion of the substances in 0.1 M hydrochloric acid in the range from 260 to 320 nm must show the absorption maximum at the wavelength of 293 ± 2nm
Solubility Slightly soluble in water, in methanol and alcohol 95%; soluble in 0.1 M hydrochloric acid; freely soluble  in glacial acetic acid
Specific optical rotation   From -95° to -103° with reference to the dried substance (1% solution of the substance in methanol)
Clarity of solution   A 0.5% freshly prepared solution of the substance in carbon dioxide-free water should be clear or stand comparison with reference suspension I.
Color of solution A 0.5% freshly prepared solution of the substance in carbon dioxide-free water must stand comparison with model Y5 or GY5
Sulphated Ashes ≤ 0.2%
Water (K. Fisher) ≤ 5.0%
Heavy metals ≤ 20ppm
Related substances (HPLC)  
(R)-oflocacin ≤ 1.0%
Other Related substances (HPLC)  
Any single impurity ≤ 0.2%
Total impurities ≤ 0.5%
Residual organic solvents (GC)  
Chloroform ≤ 60ppm
Dimethyl sulfoxide ≤ 5000ppm
Ethanol ≤ 5000ppm
Toluene ≤ 890ppm
Tetrahydrofurane ≤ 720ppm
ASSAY ≥ 98.5%

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