Description

Darifenacin(Benzofuran) Des-[(3S)-α,α-Diphenyl-3-Pyrrolidineacetamide] is a key pharmaceutical impurity and analytical reference standard used in the development and quality control of the active pharmaceutical ingredient (API) Darifenacin. This compound is critical for ensuring the purity, safety, and efficacy of Darifenacin-based medications through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Darifenacin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control (QC) & Quality Assurance (QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity acceptance criteria and control strategies.
• Stability Studies: Employed to track the formation of this degradant under various stress conditions (e.g., heat, light, humidity) as part of forced degradation studies.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Darifenacin.

Basic Information

Product Name	Darifenacin(Benzofuran) Des-[(3S)-α,α-Diphenyl-3-Pyrrolidineacetamide] (Darifenacin Impurity)
CAS No.	633335-98-5
Molecular Formula	C24H21NO2
Molecular Weight	355.43 g/mol
Synonyms	Darifenacin Des-Benzhydryl Metabolite; Darifenacin Related Compound; 2-(1-Benzofuran-5-yl)-N,N-diethylacetamide; 5-[(Diethylamino)acetyl]-1-benzofuran; Des-[(3S)-α,α-Diphenyl-3-pyrrolidineacetamide] Darifenacin; Darifenacin Impurity F (Potential); UNII-9F8V0L8IQJ
EINECS	Contact for details

Quality Control

Every batch of Darifenacin(Benzofuran) Des-[(3S)-α,α-Diphenyl-3-Pyrrolidineacetamide] is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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