Description

Dofetilide Impurity 7 CAS NO 115256-12-7 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Dofetilide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Dofetilide batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Dofetilide.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Research & Development: Utilized in R&D laboratories for studying the synthesis pathways, degradation mechanisms, and metabolism of Dofetilide.

Basic Information

Product Name	Dofetilide Impurity 7
CAS No.	115256-12-7
Molecular Formula	C19H27N3O5S2
Molecular Weight	441.56 g/mol
Synonyms	N-[4-[2-[2-(4-Methanesulfonamidophenoxy)ethyl](methyl)amino]ethyl]phenyl]methanesulfonamide; Dofetilide Related Compound; Dofetilide EP Impurity; Dofetilide USP Impurity; Dofetilide Process Impurity; Tikosyn Impurity 7; UK-68,798 Impurity
EINECS	Contact for details

Quality Control

Our Dofetilide Impurity 7 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We adhere to relevant pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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 single 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.