Description

Donepezil Impurity 46 CAS NO 2452407-73-5 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Donepezil Hydrochloride, a key medication for Alzheimer's disease. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Donepezil Impurity 46 in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for impurity profiling of Donepezil Hydrochloride.
• Stability Studies & Forced Degradation: Employed as a marker to monitor the formation of specific degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release: Essential for routine QA/QC testing to ensure each batch of Donepezil API meets stringent pharmacopeial (USP, EP) and internal purity specifications.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during synthesis, helping to optimize manufacturing processes to minimize its presence.

Basic Information

Product Name	Donepezil Impurity 46
CAS No.	2452407-73-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Donepezil Related Compound 46; Donepezil EP Impurity 46; Donepezil USP Impurity 46; Donepezil Hydrochloride Impurity 46; (E)-1-Benzyl-4-[(5,6-dimethoxy-1-oxo-3-phenyl-1H-inden-2-yl)methylene]piperidine; Aricept Impurity 46; 2452407-73-5; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Donepezil Impurity 46 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 COA. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%
Assay (HPLC)	95.0% - 105.0% on anhydrous basis

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