Description

Darifenacin n-Oxide Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is a specified impurity of Darifenacin, an active pharmaceutical ingredient used in the treatment of overactive bladder. It is critical for pharmaceutical manufacturers and analytical laboratories to ensure product quality, safety, and regulatory compliance. This impurity standard is essential for method development, validation, and quality control testing in the pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of the n-Oxide impurity in Darifenacin API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to ensure Darifenacin meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation of degradation products under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Facilitates studies on the metabolic pathways, degradation mechanisms, and synthesis of Darifenacin and related compounds.

Basic Information

Product Name	Darifenacin n-Oxide Impurity
CAS No.	1391080-40-2
Molecular Formula	C28H30N2O3
Molecular Weight	442.55 g/mol
Synonyms	Darifenacin N-Oxide; Darifenacin Impurity O (N-Oxide); (3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide N-Oxide; 1-[2-(2,3-Dihydrobenzofuran-5-yl)ethyl]-3-(diphenylacetyl)pyrrolidine N-Oxide; Darifenacin Related Compound O; Darifenacin N-Oxide Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Darifenacin n-Oxide Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided and available upon request, supporting your regulatory and quality assurance needs.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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