Description

(-)-Donepezil Hydrochloride CAS NO 142057-78-1 is the single enantiomer, high-purity active pharmaceutical ingredient (API) form of the acetylcholinesterase inhibitor donepezil. This specific enantiomer is the therapeutically active component critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is an essential raw material for manufacturers in the pharmaceutical industry, particularly those developing and producing treatments for cognitive disorders. Global suppliers require a reliable source of this API that meets stringent pharmacopeial standards for purity and consistency.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key active component in the manufacture of prescription medications for Alzheimer's disease and other forms of dementia.
• Finished Dosage Form Production: Direct compression or granulation into oral solid dosage forms, primarily film-coated tablets.
• Generic Drug Manufacturing: Sourcing for companies producing bioequivalent generic versions of donepezil-based therapies.
• Clinical Trial Material (CTM): Supply of GMP-grade material for Phase I-III clinical studies investigating new cognitive treatments or novel formulations.
• Research & Development (R&D): Utilization in preclinical and pharmacological studies within academic and institutional research settings.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control laboratories performing HPLC/LC-MS analysis.

Basic Information

Product Name	(-)-Donepezil Hydrochloride
CAS No.	142057-78-1
Molecular Formula	C24H29NO3•HCl
Molecular Weight	415.95 g/mol
Synonyms	(-)-Donepezil HCl; (R)-Donepezil Hydrochloride; Aricept API; E2020; 1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidine hydrochloride; (2R)-1-Benzyl-4-[(5,6-dimethoxy-2,3-dihydro-1H-inden-1-ylidene)methyl]piperidine hydrochloride; 2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride
EINECS	Contact for details

Quality Control

Our (-)-Donepezil Hydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure compliance with relevant pharmacopeial standards such as USP and EP monographs. Comprehensive testing includes chiral purity, assay, identification, and control of specified impurities and residual solvents. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and batch-to-batch consistency.

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 maintain stability and purity. 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)
Chiral Purity (Enantiomeric Excess)	≥ 99.5%
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 0.5%
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.