Product Name : LEVOFLOXACIN
Molecular Formula : C18H20FN3O4 ½ H2O
Molecular Weight : 370.38
Synonyms : 7H-Pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid, 9- fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-hydrate
CAS No : 100986-85-41
| Sr. No. | Test | Specifications |
|---|---|---|
| 1 | Description | A light yellowish-white to yellow white crystals or crystalline powder. |
| 2 | Identification A. By IR B. By HPLC |
The IR absorption spectrum of the test preparation should Exhibit maxima at the same wavelength as that of similarpreparation of Levofloxacin working standard.
Retention time of main peak in test preparation to be Concordant with that of main peak in standard preparation in the assay. |
| 3 | Solubility |
Soluble in dimethyl Sulphoxide and acetic acid, sparingly soluble in water, acetone and methanol, practically insoluble in glycerin and in n-octanol. |
| 4 | Specific Optical Rotation (at 20◦) |
Between – 92◦ and -106 ◦ |
| 5 | Heavy Metal | Not more than 10ppm |
| 6 | ORGANIC IMPURITIES (BY HPLC) N- Desmethyl levofloxacin Diamine derivative Levofloxacin N- oxide 9- Desfluro levofloxacin D- Isomer Any unknown Impurity Total Impurities |
Not more than 0.3% Not more than 0.3% Not more than 0.3% Not more than 0.3% Not more than 0.8% Not more than 0.1% Not more than 0.5% |
| 7 | Residue on ignition (%w/w) | Not more than 0.2% |
| 8 | Water ( By KF, 5w/w) | Between 2.0 and 3.0 |
| 9 | Assay (By HPLC, % w/w OAB) | Between 98.0 and 102.0 |