Description

5,6-Dimethoxy-2-(4-Piperidinyl)Methyl-Indan-1-One (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, ensuring drug safety and regulatory compliance. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on impurity profiling, method development, and process chemistry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other analytical methods to quantify and qualify impurities in Donepezil API and finished dosage forms.
• Impurity Profiling & Method Development: Critical for developing and validating stability-indicating analytical methods as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Process Chemistry Research: Used as a key intermediate or marker in the research and optimization of synthetic pathways for Donepezil hydrochloride.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data for drug master files.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to ensure Donepezil products meet stringent pharmacopeial (USP, EP) specifications.
• Academic & Contract Research: Utilized in universities and CROs for studies related to neuropharmacology, organic synthesis, and analytical chemistry.

Basic Information

Product Name	5,6-Dimethoxy-2-(4-Piperidinyl)Methyl-Indan-1-One (Donepezil Impurity)
CAS No.	149874-91-9
Molecular Formula	C18H25NO3
Molecular Weight	303.40 g/mol
Synonyms	Donepezil Impurity; Donepezil Related Compound; 1-(5,6-Dimethoxy-1-oxo-2,3-dihydro-1H-inden-2-yl)methyl-4-piperidine; 2-[(4-Piperidinyl)methyl]-5,6-dimethoxy-1-indanone; 5,6-Dimethoxy-2-(piperidin-4-ylmethyl)-2,3-dihydro-1H-inden-1-one; ARICEPT Impurity; E2020 Impurity
EINECS	Contact for details

Quality Control

Every batch of 5,6-Dimethoxy-2-(4-Piperidinyl)Methyl-Indan-1-One is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and identity confirmation suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your GMP and regulatory compliance requirements.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment away from direct light exposure to maintain stability and purity.

Specification

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

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