Description

Darifenacin Pyrrolidinium Dimer Impurity is a specified impurity associated with the active pharmaceutical ingredient Darifenacin, a medication used to treat overactive bladder. This impurity is a critical reference standard in the pharmaceutical development and manufacturing process, essential for ensuring product safety, efficacy, and regulatory compliance. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method validation, quality control testing, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Darifenacin drug substance and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to ensure Darifenacin products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Essential for compiling Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Darifenacin to minimize the formation of this dimeric impurity.

Basic Information

Product Name	Darifenacin Pyrrolidinium Dimer Impurity
CAS No.	1396968-57-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Darifenacin Dimer Impurity; Darifenacin Related Compound; (3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-α,α-diphenyl-3-pyrrolidineacetate Dimer Impurity; Darifenacin Hydrobromide Impurity; Darifenacin Process Impurity; Darifenacin Degradant; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Darifenacin Pyrrolidinium Dimer Impurity is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate characterization. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B and current Good Manufacturing Practice (cGMP) principles for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material should be kept in a dry environment and handled under inert conditions if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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