Description

Dofetilide Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiarrhythmic drug Dofetilide by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory bodies involved in the development and manufacture of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Dofetilide active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development & Validation: Critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Dofetilide.
• Quality Control & Assurance: Used in routine QC testing to monitor and control impurity levels in Dofetilide batches to comply with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed as an analytical marker to identify and quantify degradation products formed during forced degradation and long-term stability studies of Dofetilide.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Pharmacopoeial Testing: Supports testing to meet monograph specifications of major pharmacopoeias such as USP, EP, or BP.
• Research on Metabolism & Degradation Pathways: Aids in research to understand the chemical behavior, degradation routes, and metabolic pathways of Dofetilide.

Basic Information

Product Name	Dofetilide Impurity 4
CAS No.	115256-15-0
Molecular Formula	C19H27N3O5S2
Molecular Weight	441.57 g/mol
Synonyms	Dofetilide Related Compound 4; Dofetilide EP Impurity D; Dofetilide USP Impurity 4; N-[4-[2-[Methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide; UK-68,798 Impurity 4; (4-((2-(Methyl(2-(4-(N-methylsulfamoyl)phenoxy)ethyl)amino)ethyl)phenyl)methanesulfonamide; Dofetilide Impurity D
EINECS	Contact for details

Quality Control

Every batch of Dofetilide Impurity 4 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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