Description

5,6-Dimethoxy-2-[(4-Piperidyl)Methyl]Indane (Donepezil Impurity) is a high-purity reference standard and synthetic intermediate critical for pharmaceutical research and development. This compound is essential for the quality control and analytical validation of Donepezil, a leading medication for Alzheimer's disease treatment. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on process chemistry, impurity profiling, and regulatory compliance.

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 dosage forms.
• Impurity Profiling & Method Development: Critical for developing and validating analytical methods (e.g., HPLC, LC-MS) to monitor process-related impurities in Donepezil synthesis.
• Process Chemistry Research: Serves as a key intermediate or a marker for studying and optimizing the synthetic pathway of Donepezil hydrochloride.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Assurance/Quality Control (QA/QC): Employed in in-house quality control laboratories to ensure batch-to-batch consistency and purity of the final drug product.
• Stability Studies: Used to identify and track degradation products that may form in Donepezil under various storage conditions.

Basic Information

Item	Details
Product Name	5,6-Dimethoxy-2-[(4-Piperidyl)Methyl]Indane (Donepezil Impurity)
CAS No.	844694-83-3
Molecular Formula	C18H27NO2
Molecular Weight	289.41 g/mol
Synonyms	Donepezil Related Compound; 2-[(4-Piperidyl)methyl]-5,6-dimethoxyindane; 5,6-Dimethoxy-2-(piperidin-4-ylmethyl)-2,3-dihydro-1H-indene; 4-[(5,6-Dimethoxy-2,3-dihydro-1H-inden-2-yl)methyl]piperidine; ARICEPT Impurity; Donepezil Impurity A (Potential); E2020 Impurity
EINECS	Contact for details

Quality Control

Every batch of 5,6-Dimethoxy-2-[(4-Piperidyl)Methyl]Indane is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing HPLC purity, related substances, and structural confirmation (NMR, MS) is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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