Description

(+)-Donepezil Hydrochloride CAS NO 142097-05-0 is the single enantiomer, high-purity hydrochloride salt form of the acetylcholinesterase inhibitor donepezil. This compound is of critical importance for pharmaceutical research and development, serving as the definitive reference standard and active pharmaceutical ingredient (API) for the production of enantiomerically pure therapeutics. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the development, quality control, and production of treatments for cognitive disorders.

Application

• Active Pharmaceutical Ingredient (API): Serves as the key chiral active component in the manufacture of enantiomerically pure donepezil-based medications.
• Pharmaceutical Reference Standard: Used as a primary standard in analytical methods such as HPLC and LC-MS for the identification, assay, and impurity profiling of donepezil products.
• Neurological Research: Employed in preclinical and clinical research studies targeting acetylcholinesterase inhibition for conditions like Alzheimer's disease.
• Formulation Development: Utilized in the development of various drug delivery systems, including tablets, capsules, and orally disintegrating formulations.
• Quality Control & Regulatory Compliance: Essential for batch release testing and ensuring compliance with pharmacopoeial standards (e.g., USP, EP, JP) in GMP environments.
• Process Chemistry & Synthesis: Acts as a critical intermediate or final product in the chiral synthesis and scale-up processes for donepezil.

Basic Information

Product Name	(+)-Donepezil Hydrochloride
CAS No.	142097-05-0
Molecular Formula	C24H29NO3•HCl
Molecular Weight	415.95 g/mol
Synonyms	Donepezil HCl; (R,S)-Donepezil Hydrochloride; Aricept® API; E2020; 1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidine Hydrochloride; (±)-Donepezil Hydrochloride; (RS)-Donepezil Hydrochloride; 2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone Hydrochloride
EINECS	Contact for details

Quality Control

Our (+)-Donepezil Hydrochloride is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and enantiomeric excess, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is hygroscopic (moisture-sensitive); ensure containers are sealed immediately after use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Enantiomeric Purity (Chiral HPLC)	≥ 99.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 0.50%
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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