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Terbinafine hydrochloride is a broad-spectrum antifungal drug used in dermatology. It can specifically disturb the late biodegradation of fungal sterols, selectively inhibit the activity of fungal squalene cyclooxidase, and hinder the reactivation of squalene in the process of fungal cell membrane formation, thus reaching the effect of killing or inhibiting fungi. TeTerbinafine hydrochloride is suitable for the treatment of cutaneous candidiasis, such as tinea manuum, tinea pedis, tinea femoritis, tinea corporis, and tinea versicolor, and is also the best medicine for the treatment of nail fungus.
Terbinafine hydrochloride is a systemic antifungal treatment drug, which has the advantages of rapid sterilization, strong bactericidal effect and accurate therapeutic effect, and has been widely used in the treatment of infectious diseases caused by fungi. The combination of terbinafine hydrochloride tablets and butenafine cream in the treatment of dermatophytosis has an ideal therapeutic effect, can shorten the time for the disappearance of symptoms, and has a certain safety, which is conducive to reducing the risk of recurrence and can be used as a new direction for the treatment of the disease.
Items | Specifications | Results |
Appearance (25℃) | White or almost white crystallinity powder | White crystallinity powder |
Solubility | very slightly or slightly soluble in water, freely soluble in anhydrous ethanol and in methanol, slightly soluble in acetone | Complies |
Identification | Infrared absorption spectrophotometry.Comparison: terbinafine hydrochloride CRS | Complies |
It gives reaction (a) of chlorides using nhydrous ethanol R as solvent | Complies | |
Related Substances | Impurity A ≤ 0.10% | Not Detected |
Impurity B ≤ 0.10% | Not Detected | |
Impurity C ≤ 0.10% | Not Detected | |
Impurity D ≤ 0.10% | Not Detected | |
Dimer≤0.05% | Not Detected | |
unspecified impurities: each Impurity not more than 0.1% | 0.02% | |
Sum of impurity : not more than 0.3% | 0.06% | |
Loss on drying | ≤0.5% | 0.15% |
Sulfated ash | ≤0.1% | 0.02% |
Residual Solvent | ethyl acetate≤0.5% | 0.02% |
Dichloromethane≤0.06% | Not Detected | |
Isopropanol≤0.5% | 0.04% | |
Assay | 98.0%~102.0%(dried substance) | 100.27% |
Conclusion | The product conforms to the above specifications. | |
| Product parameters | |
| Cas number: | 78628-80-5 |
| Appearance: | White or almost white powder |
| Purity: | 99%~101% |
| Package details: | 1kg/foil bag;25kg/drum |
| Brand: | Fortunachem |
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