CAS No:78628-80-5
Shelf life:2 years
The detailed specifications are as below:
| Items | Standard |
| Description | 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 | Infrared absorption spectrophotometry. Comparison: terbinafine hydrochloride CRS |
| It gives reaction (a) of chlorides using anhydrous ethanol R as solvent | |
| Related Substances | Impurity B :not more than 0.15% |
| Impurity E: not more than 0.05% | |
| unspecified impurities: each Impurity not more than 0.1% | |
| Sum of impurity : not more than 0.3% | |
| Loss on drying | ≤0.5% |
| Sulfated ash | ≤0.1% |
| Residual Solvent | ethyl acetate≤0.5% |
| dichloromethane≤0.06% | |
| isopropanol≤0.5% | |
| Assay | 99.0%-101.0% |