Description

Sotalol Related Compound C is a high-purity chemical reference standard, essential for analytical and quality control processes in the pharmaceutical industry. Its primary value lies in its use as a well-characterized impurity for the validation and calibration of analytical methods, ensuring the safety and efficacy of the active pharmaceutical ingredient, Sotalol. This compound is critically needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify related substances in Sotalol Hydrochloride API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Sotalol to understand degradation pathways.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research and Development: Used in synthetic chemistry research to study the metabolism and degradation of Sotalol.

Basic Information

Product Name	Sotalol Related Compound C
CAS No.	16974-44-0
Molecular Formula	C12H20N2O3S
Molecular Weight	272.36 g/mol
Synonyms	N-[4-[1-Hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]methanesulfonamide; Sotalol Impurity C; Sotalol EP Impurity C; Sotalol Related Substance C; 4'-[1-Hydroxy-2-(isopropylamino)ethyl]methanesulfonanilide; Sotalol Metabolite; Sotalol Hydrochloride Related Compound C
EINECS	Contact for details

Quality Control

Our Sotalol Related Compound C is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by advanced chromatographic techniques (HPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the batch-specific results. We support compliance with ICH Q3A/B, USP, and European Pharmacopoeia guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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