Description

Donepezil Impurity 3 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Donepezil Hydrochloride, a medication used to treat Alzheimer's disease. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, method development, and validation. The accurate identification and quantification of this impurity are essential for compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Donepezil Impurity 3 in API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial monographs (USP, EP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation and increase of this specific impurity under various stress conditions (e.g., heat, light, humidity) over time.
• Research & Development (R&D): Facilitates studies on the degradation pathways and chemical behavior of Donepezil Hydrochloride.

Basic Information

Product Name	Donepezil Impurity 3
CAS No.	1023500-88-0
Molecular Formula	C24H29NO3
Molecular Weight	379.50 g/mol
Synonyms	Donepezil Related Compound 3; Donepezil EP Impurity C; 1-Benzyl-4-[(5,6-dimethoxy-1-oxoindan-2-yl)methyl]piperidine; 2-[(1-Benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-1H-inden-1-one; Donepezil Impurity C; Donepezil Hydrochloride Impurity 3
EINECS	Contact for details

Quality Control

Our Donepezil Impurity 3 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 comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment aligns with the requirements for pharmaceutical reference standards and supports compliance with ICH Q3A(R2) and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term stability, store under inert atmosphere if specified.

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 unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	98.0% - 102.0%

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