Description

Donepezil Impurity 8 is a high-purity chemical reference standard used in the analytical profiling and quality control of Donepezil Hydrochloride, a key active pharmaceutical ingredient for Alzheimer's disease treatment. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry, supporting the production of high-quality finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Donepezil Hydrochloride API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies & Forced Degradation: Used to monitor the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data for health authorities like the US FDA and EMA.
• Pharmacopoeial Testing: Aids in compliance testing against monograph specifications in USP, EP, or other international pharmacopoeias.
• Process Chemistry & Optimization: Helps API manufacturers identify the source of impurity formation during synthesis, enabling process refinement for higher purity.

Basic Information

Product Name	Donepezil Impurity 8
CAS No.	1808997-65-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Donepezil Related Compound 8; Donepezil EP Impurity 8; Donepezil USP Impurity 8; Donepezil Process Impurity 8; (R)-2-((1-Benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one Impurity; Aricept Impurity 8; 1-(1-Benzyl-4-piperidinyl)methyl-2,3-dihydro-5,6-dimethoxy-1H-inden-1-one Impurity
EINECS	Contact for details

Quality Control

Every batch of Donepezil Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (MS, NMR) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A, Q3B, and relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.