Description

Terbinafine Hydrochloride is a synthetic allylamine antifungal agent, widely recognized for its potent and broad-spectrum activity against dermatophytes and other fungi. Its primary value lies in its mechanism of action, which involves the specific inhibition of squalene epoxidase, a key enzyme in fungal ergosterol biosynthesis, leading to fungal cell death. This compound is essential for pharmaceutical manufacturers and research institutions developing topical and oral antifungal formulations, particularly for treating conditions like onychomycosis, tinea pedis, and other cutaneous mycoses.

Application

• Active Pharmaceutical Ingredient (API): Core component in the manufacture of oral tablets and topical creams for systemic and localized antifungal therapy.
• Dermatological Preparations: Used in creams, ointments, gels, and sprays for treating athlete's foot, jock itch, and ringworm.
• Onychomycosis Treatment: Key ingredient in medicated nail lacquers and solutions targeting fungal nail infections.
• Veterinary Antifungals: Incorporated into formulations for treating fungal skin and nail infections in animals.
• Pharmaceutical Research: Serves as a reference standard and building block in microbiological research and new drug development.
• Cosmeceutical Products: Used in antifungal foot powders, soaps, and other over-the-counter hygiene products.

Basic Information

Product Name	Terbinafine Hydrochloride
CAS No.	78628-80-5
Molecular Formula	C21H26ClN • HCl
Molecular Weight	327.90 g/mol (Free base: 291.44 g/mol)
Synonyms	(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine Hydrochloride; Terbinafine HCl; SF 86-327; Lamisil (brand name active ingredient); Antifungal agent SF 86-327; (E)-N-(6,6-Dimethylhept-2-en-4-ynyl)-N-methyl-1-naphthylmethylamine hydrochloride
EINECS	Contact for details

Quality Control

Our Terbinafine Hydrochloride is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications, including identification, assay, impurity profiling, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing all test results against predefined specifications. We can supply material compliant with various pharmacopoeial standards (e.g., USP, EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and away from direct light and moisture to maintain stability and potency.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets Ph. Eur./USP criteria

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.