Description

Darifenacin 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 active pharmaceutical ingredient Darifenacin, a medication used to treat overactive bladder. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Darifenacin drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug products meet specified impurity limits per ICH, USP, or EP guidelines.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry and pharmaceutical R&D programs.

Basic Information

Product Name	Darifenacin Impurity 10
CAS No.	1048979-16-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide; Darifenacin Related Compound; Darifenacin EP Impurity; Darifenacin USP Impurity; Darifenacin Process Impurity; Darifenacin Degradation Product; Darifenacin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Darifenacin Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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%

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