NATURCHEM BCN XXI, S.L. - Barcelona
Phone (+34) 683.355.193 / (+34) 936.690.394
ITEMS | SPECIFICATIONS |
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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