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 unique mechanism of action, inhibiting ergosterol biosynthesis, which is crucial for fungal cell membrane integrity. This makes it an essential active pharmaceutical ingredient (API) for manufacturers developing topical antifungal treatments targeting conditions like onychomycosis and cutaneous mycoses.

Application

• Primary use as the active pharmaceutical ingredient (API) in topical antifungal creams, gels, and lacquers.
• Formulation of prescription and over-the-counter (OTC) medications for the treatment of onychomycosis (fungal nail infections).
• Key component in dermatological preparations for cutaneous mycoses such as athlete's foot (tinea pedis), ringworm (tinea corporis), and pityriasis versicolor.
• Used in veterinary antifungal products for skin and hoof infections in animals.
• Intermediate in the synthesis of more complex antifungal compounds and for research into novel antifungal therapies.
• Reference standard in analytical and quality control laboratories for HPLC and pharmacopoeial testing.

Basic Information

Product Name	Amorolfine
CAS No.	67467-83-8
Molecular Formula	C21H35NO
Molecular Weight	317.51 g/mol
Synonyms	Amorolfine Hydrochloride; (R,S)-2,6-Dimethyl-4-[2-methyl-3-(p-tert-butylphenyl)propyl]morpholine; (±)-Amorolfine; Ro 14-4767/000; Loceryl (brand name); Morpholine, 2,6-dimethyl-4-[2-methyl-3-[4-(1,1-dimethylethyl)phenyl]propyl]-; Antifungal agent Ro 14-4767
EINECS	Contact for details

Quality Control

Our Amorolfine is manufactured under strict quality management systems to ensure it meets the high standards required for pharmaceutical use. Each batch is subjected to comprehensive analytical testing, including identification, purity assay, and impurity profiling via HPLC. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance with your specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches 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

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