Description

Sotalol Ep Impurity A CAS NO 16974-42-8 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the antiarrhythmic drug Sotalol by enabling the accurate identification and quantification of related impurities. It is an essential tool for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments. The material is supplied to support compliance with stringent pharmacopeial guidelines for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sotalol Ep Impurity A in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods, in compliance with ICH Q2(R1) guidelines.
• Quality Control and Batch Release: Used in routine QA/QC testing to monitor impurity levels against established specifications, ensuring every batch of Sotalol API meets regulatory standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for impurity identification and qualification reports required for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic routes for Sotalol.

Basic Information

Item	Detail
Product Name	Sotalol Ep Impurity A
CAS No.	16974-42-8
Molecular Formula	C12H20N2O3S
Molecular Weight	272.36 g/mol
Synonyms	N-[4-[1-Hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]methanesulfonamide; Sotalol Impurity A; Sotalol EP Impurity A; Sotalol Related Compound A; 1-(4-((Methylsulfonyl)amino)phenyl)-2-((propan-2-yl)amino)ethanol; Sotalol Hydrochloride Impurity A
EINECS	Contact for details

Quality Control

Every batch of Sotalol Ep Impurity A is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with specifications and traceability to primary standards. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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