Description

Donepezil Impurity 33, also known as Donepezil Didesmethyl Impurity, is a high-purity chemical reference standard essential for pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Donepezil hydrochloride, a leading medication for Alzheimer's disease treatment, by serving as a key marker for impurity profiling and control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Donepezil hydrochloride Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product purity meets ICH, USP, or EP specifications.
• Stability Studies: Used to track the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity understanding and control strategies.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this impurity, improving overall yield and purity.

Basic Information

Product Name	Donepezil Impurity 33 / Donepezil Didesmethyl Impurity
CAS No.	220170-71-8
Molecular Formula	C23H27NO3
Molecular Weight	365.47 g/mol
Synonyms	(Rs)-2-[(1-Benzyl-4-Piperidyl)Methyl]-5,6-Dihydroxy-1-Indanone; Donepezil Didesmethyl Related Compound; Donepezil Impurity F; 1-Indanone, 5,6-dihydroxy-2-[(1-benzyl-4-piperidinyl)methyl]-, (2R)-; ARIP 2; Donepezil Related Compound D; Didesmethyl Donepezil Impurity
EINECS	Contact for details

Quality Control

Every batch of Donepezil Impurity 33 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

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

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