Terbinafine hydrochloride

Terbinafine hydrochloride

Product Name Terbinafine hydrochloride
CAS Number 78628-80-5
Molecular Formula C21H25N·HCl
Molecular Weight 327.89 g/mol
Appearance White to off-white crystalline powder
Specifications 99% HPLC
Solubility Soluble in ethanol, methanol, DMSO; slightly soluble in water
Melting Point 204-208°C
Loss on Drying ≤0.5%
Heavy Metals ≤10 ppm
Specification 99% HPLC

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Terbinafine hydrochloride Structure

Terbinafine hydrochloride (CAS 78628-80-5) is a synthetic allylamine antifungal agent, supplied as a white crystalline powder with ≥99% HPLC purity. It inhibits squalene epoxidase, blocking ergosterol biosynthesis in fungal cell membranes—a mechanism that is both fungicidal and fungistatic depending on the organism. This API is widely used in topical and oral formulations for the treatment of dermatophytoses, including onychomycosis and tinea infections.

Our material meets pharmacopoeial standards and is available with full documentation for regulatory filing. Each batch is tested for assay, related substances, residual solvents, and microbial limits, with COA and stability data provided on request.

Synonyms: Terbinafine HCl, (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethylamine hydrochloride, Lamisil, Terbinafine hydrochloride (USP), Terbinafine hydrochloride (EP), Terbinafine hydrochloride (BP)

Applications

  • Topical antifungal creams, gels, and sprays for tinea pedis, tinea cruris, and tinea corporis
  • Oral tablets for onychomycosis (nail fungus) treatment
  • Veterinary antifungal preparations
  • R&D and formulation development for novel drug delivery systems

Quality & Documentation

Every batch is tested for assay (HPLC ≥99%), related substances (≤0.15% per impurity), loss on drying (≤0.5%), and heavy metals (≤10 ppm). Full COA, MSDS, and TDS are available; stability data and regulatory support can be provided for DMF filing.

Packaging & Supply

Standard packaging: 1 kg, 5 kg, 25 kg; custom packing on request. In-stock items ship within 3–5 working days, MOQ from 1 kg. For pricing, samples, and bulk orders, contact our sales team.

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  • LyvBio Co., Ltd. — Email: info@lyvbio.com

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