| Function: | Antibiotic and Antimicrobial Agents |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
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| Product | TERBINAFINE Hcl | |
| Tests | Specifications | |
| 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 |
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| 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≤5000ppm | |
| trichloromethane≤60ppm | ||
| isopropyl alcohol≤5000ppm | ||
| Assay | 99.0%-101.0%(Calculated on the dried basis) | |
| Conclusion : Conforms to EP9.0 | ||
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