Description

Dofetilide Impurity 10 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 regulatory bodies for method development, validation, and impurity profiling studies. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug substance and drug product manufacturing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Dofetilide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Dofetilide.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Dofetilide.
• Research & Development: Facilitates research into the synthesis, metabolism, and degradation pathways of Dofetilide.

Basic Information

Product Name	Dofetilide Impurity 10
CAS No.	1803592-87-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dofetilide Related Compound 10; Dofetilide Specified Impurity 10; Dofetilide Process Impurity; (4-{[(2-{[4-(4-Cyano-2-methoxyphenoxy)butyl]amino}ethyl)amino]sulfonyl}phenyl)methanesulfonamide; UNII-9L7Z8J2F5F; 9L7Z8J2F5F; Dofetilide Impurity (1803592-87-1)
EINECS	Contact for details

Quality Control

Our Dofetilide Impurity 10 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results and confirming compliance with relevant standards. Our quality commitment supports your needs for reliable and traceable impurities in regulatory submissions and quality control.

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 material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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