Product Name : OFLOXACIN
Molecular Formula :C18H20FN3O4
Molecular Weight : 361.37
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( + )
CAS No : 82419-36-1
| Sr. No. | Test | Specifications |
|---|---|---|
| 1 | Description | Pale yellowish-white to light yellowish-white crystals or crystalline powder. |
| 2 | Solubility | Sparingly soluble in chloroform; slightly soluble in alcohol, in methanol and in water. |
| 3 | Identification – By IR – By UV |
The IR absorption spectrum of the test preparation should exhibit maxima at the same wavelength as that of a similar preparation of Ofloxacin working standard.
To comply |
| 4 | Residue on ignition (%w/w) | Not more than 0.1 |
| 5 | Arsenic (µg/g) | Not more than 1 |
| 6 | Heavy Metal | Not more than 10μ g/g |
| 7 | Organic Impurities (By HPLC,% w/w) Individual Impurity Total Impurities |
Not more than 0.3 Not more than 0.5 |
| 8 |
Residual Solvents (By GCHS,%w/w) Methanol Ethanol |
Not more than 0.005 Note more than 0.05 |
| 9 | Optical rotation | Between +1° and -1° |
| 10 | Loss on drying (%w/w) | Not more than 0.20 |
| 11 | Assay (By Chemical, %w/w)ODB | Between 98.5 and 101.5 |