Description

Dofetilide Impurity 8 is a specified impurity and reference standard used in the analytical profiling and quality control of the antiarrhythmic pharmaceutical, Dofetilide. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Dofetilide Impurity 8 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure every batch of Dofetilide API meets the required purity specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the impurity profile of the drug substance.
• Pharmacopeial Testing: Supports testing to meet the monograph requirements of various pharmacopeias such as USP, EP, or BP where specified.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Dofetilide, supporting formulation improvement.

Basic Information

Product Name	Dofetilide Impurity 8
CAS No.	115256-14-9
Molecular Formula	C19H27N3O5S2
Molecular Weight	441.57 g/mol
Synonyms	N-[4-[2-[5-(4-Methoxybenzoyl)amino-2-methoxyphenyl]ethyl]methylsulfonylamino]butyl]methanesulfonamide; Dofetilide Related Compound 8; Dofetilide EP Impurity B; Dofetilide USP Related Compound B; Dofetilide Process Impurity; Tikosyn Impurity 8; (α-[2-[[[4-(Methylsulfonyl)amino]butyl]methylsulfonylamino]ethyl]-4-methoxy-3-(4-methoxybenzamido)benzenemethanol)
EINECS	Contact for details

Quality Control

Every batch of Dofetilide Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against predefined specifications. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

Storage

Preserve in a 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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown 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.