Description

Amorolfine Hydrochloride CAS NO 78613-38-4 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 primarily required by pharmaceutical manufacturers for the formulation of topical antifungal treatments, such as nail lacquers, creams, and solutions.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in topical antifungal medications.
• Formulation of prescription and over-the-counter (OTC) nail lacquers for the treatment of onychomycosis (fungal nail infections).
• Manufacturing of dermatological creams, ointments, and solutions for skin mycoses like athlete's foot and ringworm.
• Use in veterinary antifungal preparations for topical application.
• Intermediate in pharmaceutical research and development for novel antifungal therapies.
• Potential applications in the development of antifungal coatings for medical devices or materials.

Basic Information

Product Name	Amorolfine Hydrochloride
CAS No.	78613-38-4
Molecular Formula	C21H35NO•HCl
Molecular Weight	353.97 g/mol
Synonyms	Amorolfine HCl; (R,S)-2,6-Dimethyl-4-[2-methyl-3-(p-tert-butylphenyl)propyl]morpholine Hydrochloride; (±)-Amorolfine Hydrochloride; Ro 14-4767/000; Loceryl (brand name); Morpholine, 2,6-dimethyl-4-[2-methyl-3-[4-(1,1-dimethylethyl)phenyl]propyl]-, hydrochloride (1:1); Amorolfine (base)
EINECS	Contact for details

Quality Control

Our Amorolfine Hydrochloride is manufactured under strict quality management systems. It is typically supplied to meet high-purity standards suitable for pharmaceutical applications, with specifications aligned with common pharmacopeial requirements. Certificates of Analysis (COA) documenting identity, purity, and related substances are provided with each batch to ensure traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (typically 15-25°C). Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: ≤0.5% Total impurities: ≤2.0%
Water (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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