Description

Amorolfine is a potent allylamine antifungal agent, widely recognized for its efficacy against a broad spectrum of dermatophytes and yeasts. Its primary value lies in its mechanism of action, which inhibits ergosterol biosynthesis, a critical component of fungal cell membranes, making it a cornerstone in antifungal formulations. This compound is essential for manufacturers in the pharmaceutical industry developing topical treatments for conditions like onychomycosis and cutaneous mycoses, as well as for research institutions studying antifungal resistance and novel drug delivery systems.

Application

• Topical Antifungal Pharmaceuticals: Primary active ingredient in medicated nail lacquers, creams, and solutions for treating fungal nail infections (onychomycosis) and skin mycoses.
• Veterinary Medicine: Used in formulations to treat fungal infections in animals, including dermatophytoses.
• Active Pharmaceutical Ingredient (API) Synthesis: Serves as a key intermediate or the final API in the production of finished antifungal drugs under GMP conditions.
• Research & Development: Utilized in microbiological and pharmacological research to study antifungal activity, mechanisms of action, and for developing new combination therapies.
• Cosmeceutical Preparations: Incorporated into specialized foot care and hygiene products designed for antifungal protection.

Basic Information

Product Name	Amorolfine
CAS No.	288583-03-9
Molecular Formula	C21H35NO
Molecular Weight	317.51 g/mol
Synonyms	(±)-Amorolfine; Amorolfine Hydrochloride (salt form); (RS)-2,6-Dimethyl-4-[2-methyl-3-(p-tert-butylphenyl)propyl]morpholine; Ro 14-4767/002; Loceryl (brand name); P-3058; Antifungal agent P-3058; Morpholine derivative P-3058
EINECS	Contact for details

Quality Control

Our Amorolfine is produced and tested to meet high-purity standards suitable for pharmaceutical applications. Each batch undergoes rigorous analytical testing, including HPLC for assay and impurity profiling, to ensure identity, potency, and purity. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all test results against agreed specifications. Our quality system supports compliance with GMP and ICH guidelines, ensuring reliability for critical API manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

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%
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.