Description

Dofetilide n-Methylsulfonyl Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiarrhythmic drug Dofetilide by serving as a key marker for impurity profiling. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development and validation. The precise characterization of this impurity is fundamental for meeting stringent pharmacopeial standards in active pharmaceutical ingredient (API) manufacturing.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the n-Methylsulfonyl impurity in Dofetilide API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor and control this specific impurity during manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Dofetilide products comply with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate comprehensive impurity control.
• Stability Studies: Employed as an analytical marker to track impurity formation and profile changes in Dofetilide under various stress and long-term storage conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this impurity during Dofetilide production.

Basic Information

Product Name	Dofetilide n-Methylsulfonyl Impurity
CAS No.	937195-03-4
Molecular Formula	C19H27N3O5S2
Molecular Weight	441.56 g/mol
Synonyms	N-[4-[2-[Methyl[2-[4-(methylsulfonyl)phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide; Dofetilide Related Compound; Dofetilide Sulfonamide Impurity; Dofetilide N-Methyl Sulfone Impurity; Dofetilide Process Impurity; UK-68,798 Impurity; (Dofetilide n-Methyl Sulfonyl Analog)
EINECS	Contact for details

Quality Control

Our Dofetilide n-Methylsulfonyl Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, NMR, and IR to confirm identity and purity, ensuring it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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