Description

Donepezil Impurity (CAS No. 197010-25-6) is a high-purity reference standard used in the analytical profiling and quality control of Donepezil Hydrochloride, a key active pharmaceutical ingredient (API) for Alzheimer's disease treatment. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is essential for method development, validation, and stability studies within the pharmaceutical and fine chemical sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Donepezil Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to separate and quantify impurities in Donepezil.
• Stability Studies & Forced Degradation: Used to identify and monitor degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Research & Development: Serves as a key intermediate or marker in synthetic pathway studies and process chemistry optimization for Donepezil.
• Contract Research & Testing Laboratories (CROs/CTLs): Utilized by third-party labs offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Donepezil Impurity
CAS No.	197010-25-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Donepezil Related Compound; Donepezil Process Impurity; Donepezil Degradant; 1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidine Impurity; Aricept Impurity; E2020 Impurity; (RS)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone Related Substance
EINECS	Contact for details

Quality Control

Our Donepezil Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopoeial standards.

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 desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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