| Powder: | Yes |
|---|---|
| Customized: | Customized |
| Certification: | GMP, ISO 9001, USP, BP |
| Suitable for: | Elderly, Adult |
| State: | Powder |
| Purity: | >98% |
| Samples: |
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| Customization: |
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| Terbinafine Hydrochloride Basic information | |
| Product Name: | Terbinafine Hydrochloride |
| CAS: | 78628-80-5 |
| MF: | C21H26ClN |
| EINECS: | 616-640-4 |
| Terbinafine Hydrochloride Chemical Properties | |
| Melting point | 204-208°C |
| storage temp. | -20°C Freezer |
| solubility | methan: soluble50mg/mL |
| form | powder |
| color | white |
| Merck | 149,156 |
| CAS DataBase Reference | 78628-80-5(CAS DataBase Reference) |
Terbinafine Hydrochloride spec:
| Items | Specifications | Results |
| Appearance | White or almost white powder | White powder |
| Solubility | Practically insoluble in water and in aceto, soluble in ethan and in methan | Complies |
| A: IR | The infrared absorption spectrum exhibits maximum only at the same wavelengths as that of the standard sample | Complies |
| B: | It gives reaction of chlorides | Complies |
| Impurity A NMT 0.1% | 0.00% | |
| Impurity B NMT 0.1% | 0.01% | |
| Impurity C NMT 0.1% | 0.02% | |
| Impurity D NMT 0.1% | 0.02% | |
| Any other impurity NMT0.1% | 0.05% | |
| Total of impurity NMT 0.3% | 0.15% | |
| Loss on drying | NMT0.5% | 0.15% |
| Sulphated ash | NMT0.1% | 0.02% |
| Assay | 99%~101% (dried substance ) | 99.85% |
Terbinafine hydrochloride a synthetic allyla antifungal. It is highly lipophilic in nature and tends to accumulate in skin, nails, and fatty tissues.
Terbinafine·HCl a member of the allyl class of antifungals, has been found to be a specific inhibitor of ergosterol synthesis via squalene epoxidase inhibition. Squalene epoxidase is an enzyme released by the dermatophyte fungi to break down Squalene, which interferes with cell membrane function and wall synthesis.
Terbinafine hydrochloride has a fungicidal effect on skin fungi and an inhibitory effect on Candida albicans. It is suitable for skin and nail infections caused by superficial fungi, such as ringworm, ringworm of the body, ringworm of the femur, ringworm of the feet, ringworm of the nail and Candida albicans infection of the skin caused by Trichophyton rubrum, Microsporum canis and Flocculus epidermidis.Terbinafine hydrochloride is a white fine crystalline powder that is freely soluble in methan and dichlorome, soluble in ethanol, and slightly soluble in water. Like other allylamines, terbinafine inhibits ergosterol synthesis by inhibiting squalene epoxidase, an enzyme that is part of the fungal cell membrane synthesis pathway. Because terbinafine prevents conversion ofsqualene to lanosterol, ergosterol cannot be synthesized. This is thought to change cell membrane permeability, causing fungal cell lysis.
1. Terbinafine Hcl 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 250mg 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 may induce or exacerbate subacute cutaneous lupus erythematosus. Persons with lupus erythematosus should first discuss possible risks with their doctor before initiation of therapy.
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