Description

Sotalol is a non-selective β-adrenergic receptor blocker (β-blocker) with additional Class III antiarrhythmic properties, making it a critical active pharmaceutical ingredient (API). Its primary value lies in its unique dual mechanism of action for the management of serious cardiac arrhythmias, such as ventricular tachycardia and atrial fibrillation. This compound is essential for pharmaceutical manufacturers developing and producing finished dosage forms, including tablets and injectables, for the global cardiovascular drug market. Sotalol CAS NO 27948-47-6 is supplied under stringent quality control to meet the exacting standards of the pharmaceutical industry.

Application

• Pharmaceutical API: Primary use as the active ingredient in antiarrhythmic medications for the treatment of life-threatening ventricular arrhythmias and maintenance of normal sinus rhythm.
• Cardiovascular Drug Formulation: Incorporated into solid oral dosage forms (e.g., tablets) and sterile injectable solutions for hospital use.
• Clinical Research: Serves as a reference standard and key material in pharmacokinetic, pharmacodynamic, and comparative efficacy studies.
• Generic Drug Manufacturing: A vital component for companies producing bioequivalent generic versions of branded sotalol hydrochloride drugs.
• Veterinary Medicine: Potential application in managing cardiac conditions in animals under veterinary supervision.

Basic Information

Product Name	Sotalol
CAS No.	27948-47-6
Molecular Formula	C12H20N2O3S
Molecular Weight	272.36 g/mol
Synonyms	Sotalol (Base); MJ 1999; (+/-)-Sotalol; DL-Sotalol; Sotacor; β-Cardone; Sotalex; 4'-[1-Hydroxy-2-(isopropylamino)ethyl]methanesulfonanilide; N-[4-[1-Hydroxy-2-(propan-2-ylamino)ethyl]phenyl]methanesulfonamide
EINECS	Contact for details

Quality Control

Our Sotalol API is manufactured and tested to meet the highest pharmacopeial standards, including USP and EP monographs. Every batch undergoes rigorous analytical testing for identity, purity, potency, and specified impurities. We provide comprehensive Certificates of Analysis (COA) that detail all test results against release specifications, ensuring full traceability and compliance with cGMP guidelines for global pharmaceutical supply.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. The container should be kept tightly sealed when not in use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Heavy Metals	NMT 20 ppm

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