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Fluconazole
| ITEMS | LIMIT |
| Appearance | White crystalline powder |
| Solubility(1gr in 10ml Methanol) | Slightly soluble in methanol. |
| Appearance of Solution | Clear and Colourless |
| Identification by IR | The Spectrum should be Concordant with reference standard solution. |
| Melting range | 138.0°C TO 142.0°C |
| Loss On Drying (At 105°C) | Not more than 0.50% |
| Heavy Metals | Not more than 20 PPM. |
| Sulphated Ash | Not more than 0.20% |
| Assay | Between 99.0% 101.0% |
| Related Substances (By HPLC) | |
| Single Impurity | NMT 0.50% |
| Total Impurities | NMT 1.00% |
| Iron Content | NMT 0.002% |
| Chloride Content | NMT 0.30% |
| Fluoride Content | Between 11.0% to 12.4% |
| Residual Solvent | Ethyl Acetate NMT 5000 PPM |
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