| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Product name | Terbinafine HCL | |||
| CAS No. | 78628-80-5 | Outer Packing | 25KG/drum | |
| Production date | 2021.05.14 | Shelf life | 2023.05.15 | |
| Standard adopted | EP7 | |||
| Items of analysis | Specification | Results | ||
| Appearance | White or off-white powder | Comply | ||
| Identification | IR, CHLORIDE | Comply | ||
| Solubility | Very slightly or slightly soluble in water, | Comply | ||
| Impurity B | ≤0.15% | 0.01% | ||
| Impurity E | ≤0.05% | Comply | ||
| Single unknown impurity | ≤0.10% | 0.05% | ||
| Total impurities | ≤0.30% | 0.15% | ||
| Loss on drying | ≤0.5% | 0.17% | ||
| Heavy metals | ≤20ppm | Comply | ||
| PH | 3.0~4.5 | 3.68 | ||
| Residue on ignition | ≤0.1% | 0.05% | ||
| i-propanol | ≤ 2000 ppm | Comply | ||
| ≤ 2000 ppm | Comply | |||
| Assay | 99~101% (Titration) | 99.92% | ||
| Storage | Keep tightly closed. Store in a cool dry place. | Keep tightly closed. Store in a cool dry place | ||
| Conclusion | Qualified | |||
Terbinafine has a primary fungicidal action in vitro against most fungal pathogens, including dermatophytes, and dimorphic and filamentous fungi. Terbinafine specifically inhibits fungal ergosterol biosynthesis at the point of squalene epoxidation. The treated fungal cells rapidly accumulate tlic intermediate squalene and become deficient in the end-product of the pathway, ergosterol.
Terbinafine is not only active after topical application but is very effective in experimental dermatophytoses following oral administration. In fungi infected guinea-pigs, the skin temperature dropps dramatically after the fourth treatment of terbinafine
Function
1. Terbinafine is mainly effective on the dermatophyte group of fungi.
2. As a 1% cream or powder, it is used topically for superficial skin infections such as jock itch (tinea cruris), athlete's foot (tinea pedis), and other types of ringworm (tinea corporis). Terbinafine cream works in about half the time required by other antifungals.
3. Oral 250-mg tablets are often prescribed for the treatment of onychomycosis, a fungal nail infection, typically by a dermatophyte or Candida species. Fungal nail infections are located deep under the nail in the cuticle to which topically applied treatments are unable to penetrate in sufficient amounts. The tablets may, rarely, cause hepatotoxicity, so patients are warned of this and may be monitored with liver function tests. Alternatives to oral administration have been studied.
4. Terbinafine hydrochloride may induce or exacerbate subacute cutaneous lupus erythematosus. Persons with lupus erythematosus should first discuss possible risks with their doctor before initiation of therapy.
Application
Anti-fungal, onychomycosis
Anti-tumor and anti-angiogenic
For athlete's foot,Onychomycosis, tinea, jock itch, tinea versicolor caused by fungi have a significant effect
For bronchial asthma, asthmatic bronchitis and emphysema
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