Description

N'-Desmethylsulfonyl-n-Methylsulfonyl Dofetilide is a high-purity chemical intermediate and reference standard of significant importance in pharmaceutical research and development. This compound is critical for analytical method development, impurity profiling, and quality control processes in the synthesis of active pharmaceutical ingredients (APIs). It is primarily needed by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on cardiovascular drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of Dofetilide and related compounds in compliance with ICH guidelines.
• Impurity Profiling: Serves as a key impurity marker in the quality control of Dofetilide API batches, ensuring product safety and efficacy.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research for cardiovascular drugs.
• Process Development & Validation: A crucial intermediate in the research, development, and scale-up of synthetic routes for antiarrhythmic agents.
• Analytical Method Development: Used to develop and validate HPLC, LC-MS, and other chromatographic methods for specificity and accuracy.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).

Basic Information

Product Name	N'-Desmethylsulfonyl-n-Methylsulfonyl Dofetilide
CAS No.	937195-06-7
Molecular Formula	C19H27N3O5S2
Molecular Weight	441.57 g/mol
Synonyms	Dofetilide Impurity; Dofetilide Related Compound; N-Desmethylsulfonyl-N-Methylsulfonyl Dofetilide; 4-[[2-[4-(Methanesulfonyl)phenyl]ethyl]amino]-1-[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]piperidine; UNII-3C1F2C8W5U; 937195-06-7; Dofetilide metabolite reference standard
EINECS	Contact for details

Quality Control

Our N'-Desmethylsulfonyl-n-Methylsulfonyl Dofetilide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical research. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Unknown Impurity	≤ 0.5%
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.