Description

Mexiletine Hydrochloride is a class IB antiarrhythmic agent, chemically known as 1-(2,6-dimethylphenoxy)-2-propanamine hydrochloride. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of medications used to manage and treat ventricular arrhythmias. It is essential for pharmaceutical manufacturers and research institutions focused on cardiovascular therapeutics, offering a reliable solution for developing life-saving treatments.

Application

• Primary Pharmaceutical Ingredient: Core active component in the manufacture of oral antiarrhythmic medications for treating ventricular tachycardia and premature ventricular contractions.
• Cardiovascular Research: Used as a reference standard and experimental compound in pharmacological studies investigating sodium channel blockade and cardiac electrophysiology.
• Generic Drug Formulation: Serves as the key API for the production of generic versions of Mexiletine Hydrochloride capsules and tablets.
• Analytical Standard: Employed in quality control laboratories for HPLC, UV, and titration methods to assay drug products and raw materials.
• Preclinical Development: Utilized in animal model studies for evaluating the efficacy, pharmacokinetics, and safety profile of antiarrhythmic agents.
• Compounding Pharmacy: Source material for specialized compounding where specific patient dosages or formulations are required.

Basic Information

Product Name	Mexiletine Hydrochloride
CAS No.	5370-01-4
Molecular Formula	C11H17NO • HCl
Molecular Weight	215.72 g/mol
Synonyms	1-(2,6-Dimethylphenoxy)-2-propanamine hydrochloride; Mexiletine HCl; KO 1173; Mexitil (brand name); 2-(2,6-Dimethylphenoxy)propylamine hydrochloride; DL-Mexiletine hydrochloride; (RS)-Mexiletine hydrochloride
EINECS	226-338-1

Quality Control

Our Mexiletine Hydrochloride is manufactured and tested under a strict quality management system. It is produced to meet pharmaceutical-grade standards, with specifications aligning with major pharmacopoeial requirements. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring full traceability and compliance for GMP-driven applications.

Storage

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

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Optical Rotation	-0.10° to +0.10° (in methanol)

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