Description

Vernakalant Hydrochloride is a pharmaceutical active ingredient and a class III antiarrhythmic agent. It is a selective atrial potassium channel blocker developed for the rapid conversion of recent-onset atrial fibrillation. This compound is of primary interest to pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in cardiovascular drug development and production. Its targeted mechanism of action makes it a key candidate for specialized cardiac rhythm management therapies.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in finished dosage forms for the treatment of atrial fibrillation.
• Cardiovascular Research: Critical reference standard and tool compound for studying atrial-selective ion channels and cardiac electrophysiology.
• Drug Formulation Development: Used in pre-formulation studies, stability testing, and the development of injectable or oral formulations.
• Clinical Trial Material (CTM) Manufacturing: Sourced for the production of batches used in Phase I-III clinical trials.
• Analytical Method Development: Serves as a high-purity standard for developing and validating HPLC, LC-MS, and other analytical methods.
• Regulatory Submissions: Used to generate data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.

Basic Information

Item	Detail
Product Name	Vernakalant Hydrochloride
CAS No.	748810-28-8
Molecular Formula	C20H28N2O3 • HCl
Molecular Weight	380.91 g/mol
Synonyms	Vernakalant HCl; (3R)-1-[(1R,2R)-2-[2-(3,4-Dimethoxyphenyl)ethoxy]cyclohexyl]pyrrolidin-3-ol hydrochloride; RSD1235; RS-1235; (1R,2R)-N-(3-Pyrrolidinyl)-2-(3,4-dimethoxyphenethoxy)cyclohexanamine hydrochloride; Atrial-selective antiarrhythmic agent
EINECS	Contact for details

Quality Control

Our Vernakalant Hydrochloride is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength. We provide full traceability and support regulatory requirements with comprehensive documentation. Certificates of Analysis (COA) detailing purity, related substances, residual solvents, and other critical parameters are available for every lot.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤1.0%
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.