 Enrofloxacin
HCL |
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PRODUCT ENROFLOXACIN HCL |
SPECIFICATION OF ENROFLOXACIN HCL |
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S.NO |
TESTS |
SPECIFICATION |
| 1 | Description | Light yellowish to yellow coloured powder |
| 2 | Solubility (lg in 30ml of 1 M KoH) | Should be soluble in potassium Hydroxide solution. |
| 3 | Identification | a) I.R. Spectrum similar to reference standard |
| b) TLC same Rf as reference standard. | ||
| 4 | Melting Range | 220 Deg C to 225 Deg C |
| 5 | Water By K.F. | Not more than 1.0% |
| 6 | Heavy Metals | Not more than 20 ppm |
| 7 | Residue on Ignition | Not more than 0.1% |
| 8 | Chromatographic Purity | |
| a) TLC | a) TLC total impurities less than 1.0% | |
| b) BY HPLC | b) HPLC more than 99.0% | |
| 9 | Assay (on dry basis) | 99.0%-101.0% |