Factory Provide High Purity CAS 78628-80-5 Terbinafine Hydrochloride / Terbinafine HCl
Introduction
Product Name : Terbinafine Hydrochloride
Other name:lamosil;n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthalenemethanamin(e)-1-naphthalenemethanaminmon;Terbinafine Hcl
CAS No.:78628-80-5
MF:C21H26ClN
Purity :99%
MW:327.89
Melting Point :204-208°C
Appearance: White to off white Powder
Storage :Sealed in dry,Sealed in dry,Room Temperature
Terbinafine hydrochloride is an antifungal, which is highly hydrophobic and tends to accumulate in hair, skin, nails, and fatty tissue.
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 of squalene to lanosterol, ergosterol cannot be synthesize.
Item Of Analysis | Standard | Result Of Analysis |
Description | White or almost white powder | almost white powder
|
Solubility | Very slightly or slightly soluble in water, freely soluble in anhydrous ethanol and in methano.l, slightly soluble in aceton.e | Complies |
Identification | Infrared absorption spectrophotometry. Comparison: terbinafine hydrochloride CRS | Complies |
It gives reaction (a) of chlorides using anhydrous ethanol R as solvent | Complies |
Related Substances | Impurity B: not more than 0.15%, | Complies |
Impurity E: not more than 0.05%, impurity | Complies |
unspecified impurities:each Impuritynot more than 0.1% | Complies |
Sum of impurity : not more than 0.3% | Complies |
Loss on drying | ≤0.5% | 0.40% |
Sulfated ash | ≤0.1% | 0.01% |
Residual Solvent | ethyl aceta.te≤0.5% | ethyl acetat.e≤0.5% |
| dichloromethan.e≤0.06% | dichloromethan.e≤0.06% |
| isopropano.l≤0.5% | isopropano.l≤0.5% |
Assay | 99.0%-101.0% | 100.29% |
Application:
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.
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