Description

Donepezil Impurity CAS NO 896134-06-8 is a high-purity chemical reference standard used in the pharmaceutical development and quality control process. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Donepezil hydrochloride, a key active pharmaceutical ingredient (API) for treating Alzheimer's disease. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Donepezil hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure API and drug product purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Donepezil Impurity
CAS No.	896134-06-8
Molecular Formula	C24H29NO3
Molecular Weight	379.49 g/mol
Synonyms	Donepezil Related Compound; 2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one; 5,6-Dimethoxy-2-[(1-benzyl-4-piperidinyl)methyl]-1-indanone; Donepezil Impurity A; Donepezil EP Impurity A; Aricept Impurity; E2020 Impurity
EINECS	Contact for details

Quality Control

Every batch of Donepezil Impurity (CAS 896134-06-8) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity with in-house specifications and relevant pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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 individual unknown impurity ≤ 0.5%
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.