Description

Dofetilide n-Oxide CAS NO 144449-71-8 is a high-purity pharmaceutical intermediate and reference standard of significant importance in the development and quality control of active pharmaceutical ingredients (APIs). This compound is a key oxidative metabolite of Dofetilide, a Class III antiarrhythmic agent, making it critical for pharmacokinetic studies and impurity profiling. It is primarily required by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers engaged in the synthesis of cardiovascular drugs to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of Dofetilide and its related substances in drug substances and finished products.
• Metabolite Studies: Essential for in-vitro and in-vivo metabolism research to understand the pharmacokinetic profile and biotransformation pathways of Dofetilide.
• Impurity Profiling: Serves as a critical impurity marker in the analytical method development and validation for Dofetilide API, ensuring compliance with ICH guidelines on impurities.
• Process Chemistry R&D: Employed in route scouting and process optimization for the synthesis of Dofetilide, aiding in the control of oxidative degradation pathways.
• Bioanalytical Assays: Utilized in the development and calibration of LC-MS/MS and HPLC methods for the detection of Dofetilide and its metabolites in biological matrices.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish the safety profile of drug products containing Dofetilide.

Basic Information

Product Name	Dofetilide n-Oxide
CAS No.	144449-71-8
Molecular Formula	C19H27N3O5S
Molecular Weight	409.50 g/mol
Synonyms	Dofetilide N-Oxide; Dofetilide Metabolite; UK-68,798 N-Oxide; N-[4-[2-[Methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide N-Oxide; UK-68,798 N-Oxide; Dofetilide Related Compound; Dofetilide Oxidative Impurity
EINECS	Contact for details

Quality Control

Our Dofetilide n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and stringent control of residual solvents and heavy metals. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, detailing all test results against established specifications to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
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 single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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