Terbinafine Hydrochloride High Purity API Material CAS 78628-80-5
Product Description
Terbinafine Hydrochloride is an antifungal medication used to treat a variety of infections. It is typically in the form of tablets or creams. terbinafine hydrochloride is an effective antifungal medication utilized to treat various fungal infections. Whether it's addressing athlete's foot or fungal nail infections, this medication functions by hindering ergosterol production and offers both topical and oral application options for convenience and effectiveness.
COA
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ITEMS |
STANDARD |
TEST RESULT |
| Assay | 99% | Conforms |
| Color | White powder | Conforms |
| Odor | No special smell | Conforms |
| Particle size | 100% pass 80mesh | Conforms |
| Loss on drying | ≤5.0% | 2.35% |
| Residue | ≤1.0% | Conforms |
| Heavy metal | ≤10.0ppm | 7ppm |
| As | ≤2.0ppm | Conforms |
| Pb | ≤2.0ppm | Conforms |
| Pesticide residue | Negative | Negative |
| Total plate count | ≤100cfu/g | Conforms |
| Yeast & Mold | ≤100cfu/g | Conforms |
| E.Coli | Negative | Negative |
| Salmonella | Negative | Negative |
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Conclusion |
Conform with Specification |
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|
Storage |
Stored in Cool & Dry Place, Keep Away From Strong Light And Heat |
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Shelf life |
2 years when properly stored |
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Function
1.Terbinafine hydrochloride a synthetic allyla antifungal. It is highly lipophilic in nature and tends to accumulate in skin, nails, and fatty tissues.
2.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.
3.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.
Application
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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