Description

Dehydrodeoxy Donepezil is a key pharmaceutical impurity and intermediate used in the synthesis and quality control of Donepezil hydrochloride, a widely prescribed acetylcholinesterase inhibitor for the treatment of Alzheimer's disease. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, process validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of related substances in Donepezil API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Process Chemistry Research: Used as an intermediate or marker to study and optimize synthetic pathways for Donepezil, helping to understand and control impurity formation.
• Quality Assurance & Control (QA/QC): Employed in routine batch release testing to monitor impurity levels against ICH Q3A/B guidelines, ensuring product safety and efficacy.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to identify and track potential degradation products in Donepezil formulations under various stress conditions.

Basic Information

Product Name	Dehydrodeoxy Donepezil (Donepezil Impurity)
CAS No.	120013-45-8
Molecular Formula	C24H27NO3
Molecular Weight	377.48 g/mol
Synonyms	Donepezil Impurity D; Donepezil Related Compound D; 2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one; 1-[[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one; Dehydro Donepezil Impurity; AR-H069399; AR-H069399XX
EINECS	Contact for details

Quality Control

Our Dehydrodeoxy Donepezil is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards and impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and residual solvents. Our quality commitment aligns with cGMP principles for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.