Description

Darifenacin 3-Hydroxy Impurity is a key process-related impurity and degradation product of the active pharmaceutical ingredient Darifenacin. This compound is of critical importance for pharmaceutical manufacturers and analytical laboratories involved in the development, quality control, and regulatory compliance of Darifenacin-based drug products. It is primarily required by professionals in the pharmaceutical and fine chemical sectors for use as a certified reference standard in analytical method development, validation, and stability studies to ensure product purity and safety.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Darifenacin drug substances and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity levels in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Indicating Method: Used in forced degradation and long-term stability studies of Darifenacin to identify and quantify this specific degradant.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to confirm the impurity profile meets stringent pharmacopeial specifications.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity identification, qualification, and reporting thresholds.
• Process Chemistry Research: Used by R&D chemists to study and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Darifenacin 3-Hydroxy Impurity
CAS No.	206048-82-0
Molecular Formula	C28H30N2O3
Molecular Weight	442.55 g/mol
Synonyms	3-Hydroxy Darifenacin; Darifenacin 3-Hydroxy Degradant; Darifenacin Related Compound; (3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide 3-Hydroxy Derivative; 3-Hydroxy-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]-α,α-diphenyl-3-pyrrolidineacetamide; Darifenacin Impurity; Darifenacin EP Impurity; Darifenacin USP Impurity
EINECS	Contact for details

Quality Control

Our Darifenacin 3-Hydroxy Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile as determined by advanced techniques like HPLC, LC-MS, and NMR. We support compliance with ICH, USP, and EP guidelines.

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 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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