Description

Darifenacin Oxidized Impurity is a key pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Darifenacin, a medication used to treat overactive bladder. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and regulatory compliance. The precise characterization of this impurity is vital for meeting stringent pharmacopeial standards in drug development and production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quantitative and qualitative analysis of Darifenacin drug substance and finished products.
• Method Development and Validation: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC laboratories to assess batch-to-batch consistency and ensure impurity levels are within ICH guidelines.
• Regulatory Compliance and Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing identified and characterized impurity data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., oxidative stress) as per ICH Q1A(R2).
• Research and Development: Facilitates process chemistry research to understand and minimize the formation of this specific oxidative degradation pathway.

Basic Information

Product Name	Darifenacin Oxidized Impurity
CAS No.	133033-99-5
Molecular Formula	C28H30N2O3
Molecular Weight	442.55 g/mol
Synonyms	Darifenacin N-Oxide; Darifenacin Related Compound; (3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide N-Oxide; Darifenacin Impurity; Darifenacin Degradation Product; Oxidized Darifenacin; Enablex Oxidized Impurity
EINECS	Contact for details

Quality Control

Every batch of Darifenacin Oxidized Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term storage, consider storing desiccated at 2-8°C. Handle the material under an inert atmosphere if necessary to prevent further oxidation or moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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