Donepezil HCl

Synonimy: Donepezil hydrochloride, E2020, Aricept, (±)-2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride

Donepezil HCl has become a staple in the portfolios of generic drug manufacturers and CDMOs targeting the central nervous system (CNS) segment. With the global rise in Alzheimer’s disease prevalence and the ongoing shift toward affordable generics, demand for this API remains robust across regulated and emerging markets alike.

Chemically, Donepezil HCl is a piperidine-based indanone derivative. It is the hydrochloride salt of donepezil, a reversible acetylcholinesterase inhibitor. The free base is a viscous oil, but the hydrochloride form offers the crystallinity and water solubility required for solid oral dosage forms.

LyvBio supplies Donepezil HCl in a single, high-purity grade suitable for immediate formulation into film-coated tablets. Our material is manufactured under cGMP conditions, with full traceability and regulatory support.

Product Overview & Composition

Donepezil HCl is a synthetic small molecule with a molecular weight of 415.95 g/mol. It is a white to off-white crystalline powder, freely soluble in water and methanol. The molecule contains a dimethoxyindanone moiety linked via a methylene bridge to a benzylpiperidine ring, a structure that confers high selectivity for acetylcholinesterase over butyrylcholinesterase.

Our production process yields a single polymorphic form, ensuring consistent dissolution and bioavailability across batches. Each lot is tested for assay, related substances, residual solvents, and particle size to meet the tight specifications of solid dosage manufacturing.

Key Applications

• Alzheimer’s disease therapy: The primary use of Donepezil HCl is in the symptomatic treatment of mild to moderate Alzheimer’s dementia. It is the most prescribed cholinesterase inhibitor worldwide.
• Generic formulations: Widely used in immediate-release and orally disintegrating tablets (ODTs) by generic manufacturers.
• Combination products: Increasingly incorporated into fixed-dose combinations with memantine for moderate-to-severe Alzheimer’s.
• Clinical research: Reference standard for bioequivalence studies and analytical method development.

Quality & Standards

Packaging & Supply

• Opakowanie: 25 kg fiber drums with double polyethylene liners, or as per customer request.
• MOQ: 1 kg for pilot scale; 25 kg for commercial orders.
• Czas realizacji: 3–5 dni roboczych (towary dostępne w magazynie)
• Dokumentacja: COA, MSDS, TDS, stability data, and DMF support available upon request.

Zapytanie ofertowe

• LyvBio Sp. z o.o. — E-mail: info@lyvbio.com