Description

Donepezil CAS NO 120014-06-4 is a potent and selective acetylcholinesterase inhibitor, representing a cornerstone in the treatment of cognitive decline. Its primary value lies in its ability to enhance cholinergic neurotransmission, offering a targeted therapeutic approach for memory and cognitive function support. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing formulations for Alzheimer's disease and related neurological conditions, ensuring product efficacy and regulatory compliance.

Application

• Pharmaceutical API: The primary and most significant application is as the active ingredient in prescription medications for the symptomatic treatment of mild to moderate Alzheimer's disease.
• Neurological Disorder Research: Serves as a critical reference standard and investigational compound in preclinical and clinical research focused on cholinergic pathways and cognitive disorders.
• Generic Drug Formulation: Used by generic pharmaceutical companies to produce bioequivalent versions of branded donepezil hydrochloride tablets (e.g., Aricept®).
• Controlled-Release & Novel Delivery Systems: Incorporated into advanced drug delivery platforms, such as transdermal patches or sustained-release formulations, to improve patient compliance and therapeutic profiles.
• Analytical Standard: Employed as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical methods to ensure the identity, strength, and purity of finished drug products.
• Combination Therapy Development: Investigated for use in combination with other therapeutic agents (e.g., memantine) for enhanced treatment strategies in cognitive impairment.

Basic Information

Product Name	Donepezil
CAS No.	120014-06-4
Molecular Formula	C24H29NO3
Molecular Weight	379.49 g/mol
Synonyms	Donepezil Base; (±)-2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one; E2020; Aricept (as hydrochloride salt); 1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidine; (RS)-2-[(1-Benzylpiperidin-4-yl)methyl]-5,6-dimethoxyindan-1-one
EINECS	Contact for details

Quality Control

Our Donepezil is manufactured under strict quality management systems to meet the exacting standards of the global pharmaceutical industry. Every batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling (related substances), residual solvents, and heavy metals analysis, ensuring compliance with ICH Q3A, Q3B, and Q3C guidelines. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming the product's identity, purity, and conformance to agreed specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The container should be kept in a well-ventilated area and protected from 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)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C Class 1, 2 & 3 limits
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 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.