Description

Oxo Sotalol Hydrochloride is a key pharmaceutical intermediate and reference standard used in the development and quality control of cardiovascular medications. Its primary value lies in its role as a precursor to Sotalol Hydrochloride, a widely prescribed Class III antiarrhythmic agent. This high-purity compound is essential for pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in drug synthesis, impurity profiling, and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: Critical precursor in the synthesis of the active pharmaceutical ingredient (API) Sotalol Hydrochloride.
• Reference Standard: Used as a certified reference material (CRM) for analytical method development, validation, and quality control in pharmaceutical labs.
• Impurity Standard: Employed for the identification and quantification of process-related impurities and degradation products in Sotalol API and finished dosage forms.
• Research & Development: Serves as a building block in medicinal chemistry for creating novel analogs and studying structure-activity relationships (SAR).
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing a characterized material for stability studies and specification setting.

Basic Information

Product Name	Oxo Sotalol Hydrochloride
CAS No.	5576-49-8
Molecular Formula	C12H21ClN2O4S
Molecular Weight	324.82 g/mol
Synonyms	4'-[1-Hydroxy-2-(isopropylamino)ethyl]methanesulfonanilide Hydrochloride; N-[4-[1-Hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]methanesulfonamide Hydrochloride; Oxo-Sotalol HCl; Sotalol Impurity F (Hydrochloride); Sotalol Related Compound F; 1-(4-((Methylsulfonyl)amino)phenyl)-2-((propan-2-yl)amino)ethanol Hydrochloride
EINECS	Contact for details

Quality Control

Our Oxo Sotalol Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide full traceability and detailed Certificates of Analysis (COA) with each shipment, supporting compliance with cGMP and ICH guidelines for pharmaceutical intermediates and reference standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤2.0%

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