Description

Amorolfine Hydrochloride is a potent synthetic antifungal agent belonging to the morpholine class. Its primary value lies in its broad-spectrum fungicidal and fungistatic activity, particularly effective against dermatophytes, yeasts, and molds. This makes it a critical active pharmaceutical ingredient (API) for manufacturers in the pharmaceutical and personal care industries, specifically for developing topical treatments for fungal infections such as onychomycosis and tinea.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter (OTC) antifungal creams, gels, lacquers, and sprays.
• Onychomycosis Treatments: Key component in medicated nail lacquers specifically formulated to treat fungal infections of the fingernails and toenails.
• Dermatological Preparations: Formulated into topical solutions and creams for treating tinea (ringworm) infections, including athlete's foot (tinea pedis), jock itch (tinea cruris), and body ringworm (tinea corporis).
• Veterinary Pharmaceuticals: Used in antifungal preparations for treating superficial fungal infections in animals.
• Cosmetic & Personal Care: Incorporated into specialized foot care products and antifungal powders where ingredient efficacy is paramount.
• Research & Development: Serves as a reference standard and building block in microbiological research and the development of new antifungal agents.

Basic Information

Product Name	Amorolfine Hydrochloride
CAS No.	106614-68-0
Molecular Formula	C21H35NO•HCl
Molecular Weight	353.97 g/mol
Synonyms	Amorolfine HCl; (R,S)-2,6-Dimethyl-4-[2-methyl-3-(p-tert-pentylphenyl)propyl]morpholine hydrochloride; (±)-Amorolfine hydrochloride; Ro 14-4767/002; Loceryl (brand name); Morpholine, 2,6-dimethyl-4-[2-methyl-3-[4-(1,1-dimethylpropyl)phenyl]propyl]-, hydrochloride (1:1); 4-[2-Methyl-3-(4-tert-pentylphenyl)propyl]-2,6-dimethylmorpholine hydrochloride
EINECS	Contact for details

Quality Control

Our Amorolfine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming identity, purity, and compliance with in-house specifications. We support compliance with ICH guidelines, and production can be aligned with cGMP requirements upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The original container should be resealed immediately after use to minimize exposure to atmospheric moisture.

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 (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Optical Rotation	Contact for details

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