Description

Donepezil Hydrochloride is a high-purity, small-molecule active pharmaceutical ingredient (API) primarily used as a potent and selective acetylcholinesterase inhibitor. Its core value lies in its critical role in the formulation of medications for the symptomatic treatment of mild to moderate Alzheimer's disease. This compound is essential for pharmaceutical manufacturers and research institutions engaged in neurology-focused drug development and production. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final therapeutic products.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for Alzheimer's disease, such as Aricept® and its generic equivalents.
• Neurological Research: A key reference standard and tool compound in preclinical studies investigating cholinergic pathways, cognitive function, and neurodegenerative disorders.
• Generic Drug Formulation: Serves as the core component for manufacturers developing and producing bioequivalent generic versions of donepezil-based therapies.
• Controlled-Release Dosage Forms: Used in the development of advanced delivery systems, including extended-release tablets and transdermal patches, to improve patient compliance.
• Analytical Reference Standard: Employed in quality control laboratories for HPLC, LC-MS, and other analytical methods to assay finished drug products and raw materials.
• Combination Therapy Development: Investigated for use in combination with other agents (e.g., memantine) for enhanced therapeutic outcomes in cognitive impairment.

Basic Information

Product Name	Donepezil Hydrochloride
CAS No.	120011-70-3
Molecular Formula	C24H29NO3•HCl
Molecular Weight	415.95 g/mol
Synonyms	1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidine hydrochloride; E2020; Aricept (brand name); (±)-2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride; Donepezil HCl; (RS)-Donepezil Hydrochloride
EINECS	Contact for details

Quality Control

Our Donepezil Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, 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. We support compliance with major pharmacopoeial standards (USP, EP, JP) and can tailor specifications to meet specific customer 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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)
Related Substances (HPLC)	Total impurities ≤ 0.5% Any single impurity ≤ 0.1%
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 10 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.