Description

Sotalol Hydrochloride is a non-selective β-adrenergic receptor blocking agent with Class III antiarrhythmic properties. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of life-saving cardiovascular medications. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of antiarrhythmic drugs for the treatment of serious heart rhythm disorders such as ventricular tachycardia and atrial fibrillation.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms (tablets, capsules) for treating cardiac arrhythmias.
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development, validation, and quality control testing in pharmaceutical laboratories.
• Clinical Research: Utilized in preclinical and clinical studies to investigate new therapeutic applications or formulations of sotalol.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent generic versions of branded antiarrhythmic medications containing sotalol hydrochloride.
• Pharmacological Research: Used in vitro and in vivo studies to explore the mechanisms of β-blockade and potassium channel blockade.

Basic Information

Product Name	Sotalol Hydrochloride
CAS No.	959-24-0
Molecular Formula	C12H20N2O3S•HCl
Molecular Weight	308.82 g/mol
Synonyms	MJ 1999; Sotalol HCl; d,l-Sotalol hydrochloride; (RS)-Sotalol hydrochloride; 4'-[1-Hydroxy-2-(isopropylamino)ethyl]methanesulfonanilide hydrochloride; N-[4-[1-Hydroxy-2-(propan-2-ylamino)ethyl]phenyl]methanesulfonamide hydrochloride
EINECS	Contact for details

Quality Control

Our Sotalol Hydrochloride is manufactured and tested under strict quality management systems. We ensure compliance with major pharmacopoeial standards, including USP and EP monographs. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, providing full traceability and supply chain reliability for our global partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Optical Rotation	-0.10° to +0.10° (c=1 in water)

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