Description

Dofetilide Impurity 9 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 pharmaceutical agent Dofetilide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for accurate quantification and control of this specific impurity in the active pharmaceutical ingredient (API) and finished drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Dofetilide Impurity 9 in drug substance and drug product analysis.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control and Batch Release Testing: Essential for routine quality control testing to ensure Dofetilide API and formulations meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of product-related impurities.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the fate of this impurity.

Basic Information

Product Name	Dofetilide Impurity 9
CAS No.	1803604-79-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dofetilide Related Compound 9; Dofetilide Specified Impurity 9; Dofetilide Process Impurity; Dofetilide Degradant; Dofetilide Analog; (4-[(2-{[4-(Methanesulfonamido)phenoxy]methyl}-1H-imidazol-1-yl)methyl]benzonitrile) (Tentative); Tikosyn Impurity 9
EINECS	Contact for details

Quality Control

Our Dofetilide Impurity 9 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques such as HPLC, NMR, and MS. We adhere to stringent internal quality standards suitable for pharmaceutical reference material applications, supporting compliance with cGMP and ICH Q3A/B guidelines.

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 Certificate of Analysis. Due to its hygroscopic nature, the container should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% 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.