Terbinafine Hydrochloride
Character:
Terbinafine Hydrochloride is white or off-white crystalline powder with a slight odour.
This product is easily soluble in methanol or ethanol, slightly soluble or very slightly soluble in water, and almost insoluble in acetic acid.
Brief Introduction:
Terbinafine hydrochloride is an organic compound with the chemical formula C21H26ClN. It is an antifungal drug that can treat skin, hair and nail infections caused by Trichophyton(Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton trichophyton, Trichophyton violaceum, etc.), Microsporum canis and Epidermophyton floccosum.
It can also treat various ringworms(tinea corporis, tinea cruris, tinea manus, foot, and tinea capitis, etc.), skin yeast infections caused by Candida (Candida albicans, etc.), and onychomycosis caused by mold.
Specifications of our Terbinafine Hydrochloride(Terbinafine HCL):
| Test Items | Specifications |
| 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 | 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 impurities: Not more than 0.3% | |
| Loss on Drying | Not more than 0.5% |
| Sulphated Ash | Not more than 0.1% |
| Residual Solvents | Ethyl Acetate: Not more than 0.5% |
| Dichloromethane: Not more than 0.06% | |
| Isopropanol: Not more than 0.5% | |
| Particle Size | Meets the requirements |
| Assay | 99.0% ~ 101.0% |
Executive Standard:
EP 9.0
Pharmacological Effects:
Terbinafine hydrochloride is an allylamine drug with broad-spectrum antifungal activity. This product can specifically interfere with the early biosynthesis of fungal ergosterol, highly selectively inhibit the fungal squalene epoxidase, and block the squalene epoxidation reaction during the formation of fungal cell membranes, thereby achieving killing or Antifungal effect.
Packaging:
1kg/Aluminum Foil Bag or 25kg/Fibre Drum.
Storage Conditions:
Preserved in unopened original containers in a cool dry place before using; kept away from direct sunlight, heat and moisture.
Shelf Life:
24 months if stored under above mentioned conditions.
