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Terbinafine Hydrochloride
| ITEMS | LIMIT |
| Appearance | White or almost white powder |
| Solubility | Very slightly or slightly soluble in water, freely soluble in anhydrous ethanol and in methanol, slightly soluble in acetone |
| Identification | |
| A: Infrared Absorption | |
| B: Test for chloride | |
| Melting point | Between 204.0℃-208.0℃ |
| Related Substances | |
| 1.N-Methyl-C-(naphthalene-1-yl) methanamine | |
| Not more than 0.1% | |
| 2.trans-Isoterbinafine | Not more than 0.1% |
| 3.cis-Terbinafine | Not more than 0.1% |
| 4.4-methylterbinafine | Not more than 0.1% |
| 5.Terbinafine dimer | Not more than 0.05% |
| 6.Any other individual impurity | Not more than 0.1% |
| Total impurities | Not more than 0.3% |
| Loss on drying | ＜0.5% |
| Sulphated ash | ＜0.1% |
| Organic solvent residua standard | Chloroform |
| Not more than 60PPM | |
| Isopropanol | Not more than 5000PPM |
| Assay | 99.0～101.0％（dried substance） |
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