Description

Donepezil Impurity CAS NO 36159-03-2 is a high-purity reference standard used in the analytical profiling and quality control of Donepezil Hydrochloride, a key active pharmaceutical ingredient (API) for Alzheimer's disease treatment. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on method development, validation, and compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of specific impurities in Donepezil Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or GC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure every batch of Donepezil API meets stringent pharmacopeial (USP, EP, JP) and internal specifications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation pathways and establish shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Supports investigative studies to understand the chemical behavior and degradation mechanisms of Donepezil under various conditions.

Basic Information

Product Name	Donepezil Impurity
CAS No.	36159-03-2
Molecular Formula	C24H29NO3
Molecular Weight	379.49 g/mol
Synonyms	Donepezil Related Compound; 1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidine; 2-[(1-Benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-1-indanone; Aricept Impurity; E2020 Impurity; (RS)-2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one
EINECS	Contact for details

Quality Control

Our Donepezil Impurity (CAS 36159-03-2) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, GC-MS, NMR, and IR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results for all critical parameters. Our quality standards are designed to support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP) for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material in accordance with good laboratory practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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 guidelines
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.