Description

Donepezil Impurity 2 is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of related substances in Donepezil Hydrochloride active pharmaceutical ingredients (APIs) and finished drug products. It is an essential tool for research scientists and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Donepezil Hydrochloride API and formulations.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing of pharmaceutical batches.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Donepezil products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of Donepezil-related substances.

Basic Information

Product Name	Donepezil Impurity 2
CAS No.	36517-91-6
Molecular Formula	C24H29NO3
Molecular Weight	379.49 g/mol
Synonyms	Donepezil Related Compound B; 1-Benzyl-4-[(5,6-dimethoxy-1-oxoindan-2-yl)methyl]piperidine; 2-[(1-Benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-1-indanone; Aricept Impurity B; E2020 Impurity B; (RS)-2-[(1-Benzylpiperidin-4-yl)methyl]-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one
EINECS	Contact for details

Quality Control

Our Donepezil Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and structural confirmation, is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum 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
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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