Description

Dofetilide n-Nitryl Impurity is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Dofetilide by enabling the accurate identification and quantification of process-related impurities. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance and research within the cardiovascular drug sector.

Application

• Pharmaceutical Impurity Profiling and Method Development: Serves as a certified reference material for developing and validating HPLC, UPLC, and LC-MS methods to monitor Dofetilide synthesis.
• Quality Control and Assurance (QC/QA): Used as a primary standard in routine batch testing to ensure Dofetilide API meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance and Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and impurity levels.
• Stability Studies and Forced Degradation Testing: Employed to identify and track this specific impurity in stability-indicating assays under various stress conditions.
• Research and Development (R&D): Facilitates process chemistry optimization by helping scientists understand and minimize the formation of this nitryl impurity during API synthesis.
• Calibration and System Suitability: Acts as a precise calibrant for analytical instrumentation to guarantee accurate and reproducible impurity quantification.

Basic Information

Product Name	Dofetilide n-Nitryl Impurity
CAS No.	115256-45-6
Molecular Formula	C19H27N3O5S2
Molecular Weight	441.57 g/mol
Synonyms	Dofetilide Nitro Impurity; Dofetilide Related Compound; N-[4-[2-[Methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide Nitryl Derivative; Dofetilide Nitryl Analog; Dofetilide Process Impurity; Tikosyn Impurity; UK-68,798 Impurity
EINECS	Contact for details

Quality Control

Our Dofetilide n-Nitryl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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