Description

6-o-Desmethyl Donepezil Hydrochloride is a key pharmaceutical intermediate and metabolite of the active pharmaceutical ingredient Donepezil HCl. This compound is of critical importance for research, development, and quality control processes in the pharmaceutical industry. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis and analysis of acetylcholinesterase inhibitors for the treatment of Alzheimer's disease.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis and process development of Donepezil Hydrochloride API.
• Reference Standard: Used as a certified reference material (CRM) for analytical method development and validation in quality control laboratories.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism and biological activity of Donepezil.
• Impurity Profiling: Serves as a specified impurity standard to monitor and control the quality of the final Active Pharmaceutical Ingredient (API).
• Bioanalytical Research: Employed in the development of bioassays and diagnostic tests related to Alzheimer's disease therapeutics.
• Regulatory Submissions: Supports drug master files (DMFs) and regulatory dossiers by providing characterization data for metabolites and related substances.

Basic Information

Product Name	6-o-Desmethyl Donepezil Hydrochloride
CAS No.	852285-82-6
Molecular Formula	C23H28ClNO3
Molecular Weight	401.93 g/mol
Synonyms	6-O-Desmethyl Donepezil HCl; Donepezil Impurity F; Donepezil Related Compound F; 1-Benzyl-4-[(5,6-dimethoxy-1-oxoindan-2-yl)methyl]piperidine Hydrochloride (Desmethyl derivative); ARICEPT® Metabolite; (RS)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone Hydrochloride; E2020 Desmethyl Impurity
EINECS	Contact for details

Quality Control

Our 6-o-Desmethyl Donepezil Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
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.