Description

Dofetilide Impurity 12 is a specified impurity and reference standard used in the analytical profiling and quality control of the antiarrhythmic pharmaceutical agent, Dofetilide. Its precise characterization is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. This high-purity compound is essential for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and manufacturers of active pharmaceutical ingredients (APIs) who require reliable reference materials for method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Dofetilide Impurity 12 in Dofetilide API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor this specific impurity.
• Quality Control & Batch Release: Used in routine QA/QC testing to ensure Dofetilide batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed as an analytical marker to track the formation of this impurity during forced degradation and long-term stability studies of Dofetilide.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Dofetilide under various stress conditions.

Basic Information

Product Name	Dofetilide Impurity 12
CAS No.	103790-20-1
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; Dofetilide Sulfonamide Impurity; Dofetilide Process Impurity; Tikosyn Impurity 12; UK-68,798 Impurity; (R)-N-[4-[2-[Methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide (enantiomer specific); Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Our Dofetilide Impurity 12 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing purity, impurity profile, and analytical results is provided with every shipment to support your regulatory and quality requirements.

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 solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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