Description

Amorolfine CAS NO 78613-35-1 is a synthetic antifungal agent belonging to the morpholine class. It is a critical active pharmaceutical ingredient (API) valued for its broad-spectrum fungicidal and fungistatic activity against dermatophytes, yeasts, and molds. This compound is essential for manufacturers in the pharmaceutical and personal care industries developing topical treatments for fungal infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in topical antifungal medications, such as nail lacquers, creams, and sprays for treating onychomycosis (nail fungus), tinea pedis (athlete's foot), and other cutaneous mycoses.
• Veterinary Medicine: Formulation into antifungal treatments for skin and hoof infections in animals.
• Personal Care & Cosmetics: Incorporation into specialized foot care products, antifungal powders, and medicated soaps.
• Agricultural Fungicides: Potential use in R&D for protecting certain high-value crops from specific fungal pathogens, subject to regional regulatory approvals.
• Research & Development: Serves as a reference standard and key intermediate in biochemical research focused on ergosterol biosynthesis inhibition and novel antifungal discovery.

Basic Information

Product Name	Amorolfine
CAS No.	78613-35-1
Molecular Formula	C21H35NO
Molecular Weight	317.51 g/mol
Synonyms	Amorolfine Hydrochloride; (R,S)-2,6-Dimethyl-4-[2-methyl-3-(4-tert-butylphenyl)propyl]morpholine; (±)-Amorolfine; Ro 14-4767/002; Loceryl (brand name); Morpholine, 2,6-dimethyl-4-[2-methyl-3-[4-(1,1-dimethylethyl)phenyl]propyl]-; 4-[2-Methyl-3-(4-tert-butylphenyl)propyl]-2,6-dimethylmorpholine
EINECS	Contact for details

Quality Control

Our Amorolfine is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure high purity and consistency, meeting specifications suitable for pharmaceutical R&D and formulation. We provide comprehensive Certificates of Analysis (COA) with each batch, detailing key parameters such as assay, related substances, and identification. Compliance with relevant ICH guidelines is maintained for critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-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%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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