ChemicalBook Product Catalog API Synthetic Anti-infective Drugs Antifungal Drugs Terbinafine Hydrochloride

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Terbinafine Hydrochloride

$ 2.00 /25Kg/Drum

Min. Order25Kg/Drum
Purity99%
Cas No78628-80-5
Supply Ability1ton
Update time2019-10-29

HubeiwidelychemicaltechnologyCo.,Ltd

6YR

China

Chemical Properties

Product Name	Terbinafine Hydrochloride
CAS No	78628-80-5
EC-No
Min. Order	25Kg/Drum
Purity	99%
Supply Ability	1ton
Release date	2019/10/29

Introduction

Terbinafine·HCl a member of the allylamine 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. Research has shown that Terbinafine also reduces the ability of fungal pathogens to generate reactive oxygen species, therefore it is noted as a free radical scavenger in vitro and could potentially contain anti-inflammatory activity in vivo.

Additionally, Terbinafine has also been reported to suppress cell proliferation in vitro and in vivo through inhibition of DNA synthesis and apoptosis activation. It has also been noted that by pretreating of cells with a p21 specific antisense oligonucleotide the Terbinafine induced inhibition of cell growth can be reversed. Assays further demonstrated that Terbinafine also contains anti-angiogenic effects in chick embryo chorioallantoic membranes.

Terbinafine is highly active against dermatophytes, mold, other basic fungi, and some strains of yeast. It is clinically used to treat nail and skin infections, inhibiting ergosterol synthesis at the stage of squalene epoxidation (IC50 = 30 nM for C. albicans). At 90-120 µM, terbinafine exhibits anti-tumor and anti-angiogenic activity by inducing cell cycle arrest at the G0/G1 stage in COLO 205 tumor cells and human vascular endothelial cells.

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.

Specification

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Items

Specifications

Results

Appearance

White Crystalline Powder

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White Crystalline Powder

Identification

Infared Absorption

Complies

The retention time of the major peak

in the chromatogram of the

Assay prepration corresponds to that in

the chromatogram of the standard preparation,

as obtained in the assay

complies

Specific rotation

Between -28.6°and -35.0°, measured at 20°

-32.8°

Water

not more than 0.5%

0.12%

residue on ignition

not more than 0.2%

0.11%

Heavy metals

not more than 0.001%

complies

related compounds by HPLC(Test1)

Fructose not more than 0.3% Compound

A not more than 0.3% Other individual impurity not more than 0.1%

Total impurities not more than 0.5%

Fructose: 0.03% Compound A: 0.04%

Total impurities: 0.07%

Particle size

90% less than 350 microns

complies

Limit of sulfamate and sulfate

Sulfamate ion not more than 0.10%

Sulfate ion not more than 0.10%

complies

Residual Solvent

Methylene Chloride not more than 250μg/g

not detected

Acetone not mor than 2500μg/g

Isopropanol not more than 5000μg/g

Ethanenitrile not more than 400μg/g

n-hexane not more than 290μg/g

Ethyl Acetate not more than 2500μg/g

Pyridine not more than 100μg/g

Assay

Topiramate contains not less than 98.0% and

not more than the equivalent of 102.0% of C12H21NO8S, calculated with reference to the Anhydrous Basis

99.80%

Conclustion

The material complies with respect to USP32

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