Description

Donepezil Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Donepezil hydrochloride, a key active pharmaceutical ingredient (API) for Alzheimer's disease treatment. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Donepezil hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for quantifying this specific impurity to ensure drug substance and product meet ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation and level of this impurity under various stress and long-term storage conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve the manufacturing process of Donepezil.

Basic Information

Product Name	Donepezil Impurity
CAS No.	844694-84-4
Molecular Formula	C24H29NO3
Molecular Weight	379.50 g/mol
Synonyms	Donepezil Related Compound; Donepezil Process Impurity; 1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidine Impurity; 2-[(1-Benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-1-indanone; Aricept Impurity; E2020 Impurity
EINECS	Contact for details

Quality Control

Our Donepezil Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with ICH Q3A, Q3B, and current Good Manufacturing Practice (cGMP) standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccator or under an inert atmosphere after opening to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (by HPLC)	≥ 98.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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