Description

Donepezil Hydrochloride is a high-purity, small-molecule pharmaceutical active ingredient (API) and a potent, selective acetylcholinesterase inhibitor. It is a critical component in the formulation of medications for the treatment of mild to moderate Alzheimer's disease, working to enhance cholinergic function in the brain. This compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of neurological therapeutics and advanced clinical research.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of finished dosage forms, primarily oral tablets and capsules, for Alzheimer's disease treatment.
• Reference Standard: Used in analytical laboratories for method development, validation, and quality control testing of drug products and raw materials.
• Clinical Research: Serves as a key material in preclinical and clinical studies for investigating neurodegenerative disorders and novel drug delivery systems.
• Generic Drug Development: Critical for companies developing bioequivalent generic versions of branded donepezil medications.
• Biochemical Research: Utilized in vitro studies to investigate the mechanisms of cholinesterase inhibition and its effects on neuronal cells.

Basic Information

Product Name	Donepezil Hydrochloride
CAS No.	110119-84-1
Molecular Formula	C24H29NO3•HCl
Molecular Weight	415.95 g/mol
Synonyms	Donepezil HCl; (±)-2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one Hydrochloride; E2020; Aricept (Brand Name API); 1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidine Hydrochloride; (RS)-Donepezil Hydrochloride
EINECS	Contact for details

Quality Control

Our Donepezil Hydrochloride is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to meet stringent specifications for pharmaceutical-grade active ingredients, including identity, purity, and impurity profiles. Certificates of Analysis (COA) are provided with each batch, detailing results from tests such as HPLC assay, related substances, residual solvents, and heavy metals. We support compliance with major pharmacopoeial standards (USP, EP, JP) and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 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.