Description

Dofetilide N`-Nitryl Impurity is a specific process-related impurity and degradation product of the antiarrhythmic pharmaceutical agent, Dofetilide. This compound is critical for pharmaceutical development and manufacturing, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in the synthesis, purification, and regulatory compliance testing of Dofetilide active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the N'-Nitryl impurity in Dofetilide API and drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and accurately measure this specific impurity.
• Quality Control & Assurance: Employed in routine batch release testing to ensure Dofetilide products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• Stability Studies: Used to monitor the formation of this degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability and shelf-life determination.
• Regulatory Submissions: Critical for preparing impurity data packages required for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Dofetilide to minimize the formation of this impurity.

Basic Information

Product Name	Dofetilide N`-Nitryl Impurity
CAS No.	115256-44-5
Molecular Formula	C19H27N3O5S2
Molecular Weight	441.57 g/mol
Synonyms	Dofetilide Nitroso Impurity; Dofetilide N-Nitroso Impurity; Dofetilide Related Compound C; N-[4-[2-[Methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide N'-Nitro Derivative; Tikosyn Impurity; UK-68,798 Impurity; 1-[4-(Methanesulfonamido)phenyl]-3-[3-(N-methyl-N-[2-[4-(N-methylmethanesulfonamido)phenoxy]ethyl]amino)propyl]urea N'-Nitro Derivative
EINECS	Contact for details

Quality Control

Our Dofetilide N`-Nitryl Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, NMR), assay (HPLC), and related substance analysis. Our quality system is designed to support regulatory compliance for use in pharmaceutical development, aligning with ICH and current Good Manufacturing Practice (cGMP) principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0% w/w

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