Description

Dofetilide Related Compound A (25 Mg) (n-[4-(2-(2-[4-(Methanesulfonamido)Phenoxy]Ethyl)Amino)Phenyl]Methanesulfonamide) is a high-purity reference standard critical for ensuring the quality and safety of the antiarrhythmic pharmaceutical, Dofetilide. This compound, with CAS number 176447-94-2, serves as a key impurity marker, enabling precise analytical control during drug development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory compliance teams focused on cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Dofetilide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Pharmacopeial Testing: Used to meet stringent purity and impurity profile requirements set by pharmacopeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Stability Studies: Employed to monitor the formation of degradation products in Dofetilide formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data on impurity characterization for regulatory filings with agencies like the FDA and EMA.
• Quality Control & Batch Release: Enables in-house QC laboratories to perform routine batch analysis, ensuring every lot of Dofetilide API meets predefined specification limits.

Basic Information

Product Name	Dofetilide Related Compound A (25 Mg) (n-[4-(2-(2-[4-(Methanesulfonamido)Phenoxy]Ethyl)Amino)Phenyl]Methanesulfonamide)
CAS No.	176447-94-2
Molecular Formula	C18H24N4O5S2
Molecular Weight	440.54 g/mol
Synonyms	N-[4-[2-[[4-(Methanesulfonamido)phenoxy]ethyl]amino]phenyl]methanesulfonamide; Dofetilide Impurity A; Dofetilide Related Substance A; UK-68,798 Related Compound A; 1-[4-(Methanesulfonamido)phenoxy]-3-[4-(methanesulfonamido)phenylamino]-2-propanol derivative; (RS)-N-[4-[2-[[4-(Methylsulfonylamino)phenoxy]ethyl]amino]phenyl]methanesulfonamide
EINECS	Contact for details

Quality Control

Our Dofetilide Related Compound A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is supplied with every unit, providing traceability and compliance support for your regulatory needs.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to maintain stability and purity.

Specification

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

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