Description

5,6-Dimethoxy-2-[(4-Piperidyl)Methyl]Indane Hydrochloride (Donepezil Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the synthesis and quality control of Donepezil, an acetylcholinesterase inhibitor used in the treatment of Alzheimer's disease. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method validation, stability studies, and regulatory compliance. Ensuring the integrity of your analytical data starts with sourcing impurities of the highest quality and documented purity.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Donepezil Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Donepezil and to establish shelf-life specifications.
• Quality Control & Batch Release: An essential tool for in-house QC laboratories to ensure every batch of Donepezil API meets stringent purity requirements before release.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) submitted to agencies like the FDA and EMA.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic routes to minimize the formation of this specific impurity during manufacturing.

Basic Information

Product Name	5,6-Dimethoxy-2-[(4-Piperidyl)Methyl]Indane Hydrochloride (Donepezil Impurity)
CAS No.	1034439-43-4
Molecular Formula	C17H25NO2 • HCl
Molecular Weight	311.85 g/mol (Free base: 275.39 g/mol)
Synonyms	Donepezil Related Compound; 2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone Impurity; 5,6-Dimethoxy-2-[(1-benzyl-4-piperidinyl)methyl]-1-indanone Impurity; ARICEPT Impurity; E2020 Impurity; 1-Indanone, 5,6-dimethoxy-2-[(4-piperidinyl)methyl]-, hydrochloride; 5,6-Dimethoxy-2-(4-piperidinylmethyl)-1-indanone hydrochloride
EINECS	Contact for details

Quality Control

Every batch of our 5,6-Dimethoxy-2-[(4-Piperidyl)Methyl]Indane Hydrochloride is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and assay, NMR and MS for structural confirmation, and stringent control of residual solvents and heavy metals. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against predefined specifications. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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. For long-term storage, consider desiccants under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Assay (on dried basis)	97.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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