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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