Description

Dofetilide Impurity 5 (CAS 115256-16-1) is a high-purity reference standard critical for the analytical profiling and quality control of the antiarrhythmic pharmaceutical, Dofetilide. This compound is essential for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Method Development & Validation: Used in the development and validation of HPLC, UPLC, and LC-MS methods for the precise quantification of Dofetilide and its related substances.
• Quality Control & Batch Release: A critical component in the quality control workflow for Dofetilide API and finished dosage forms, ensuring impurity levels remain within specified safety limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., to FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Dofetilide manufacturing process to minimize impurity formation.

Basic Information

Product Name	Dofetilide Impurity 5
CAS No.	115256-16-1
Molecular Formula	C19H27N3O5S2
Molecular Weight	441.57 g/mol
Synonyms	N-[4-[2-[Methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide; Dofetilide Related Compound B; Dofetilide EP Impurity B; Dofetilide USP Related Compound B; Dofetilide Process Impurity; Tikosyn Impurity 5; UK-68,798 Impurity
EINECS	Contact for details

Quality Control

Our Dofetilide Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents to ensure compliance with pharmaceutical reference standard requirements. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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