Description

Donepezil Impurity 7 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of Donepezil Hydrochloride, a key active pharmaceutical ingredient (API) used in the treatment of Alzheimer's disease. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Donepezil Hydrochloride API and finished dosage forms.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and LC-MS techniques.
• Quality Control and Assurance to monitor impurity profiles and ensure batch-to-batch consistency in API manufacturing.
• Regulatory Compliance and Submission, providing essential data for drug master files (DMFs) and regulatory filings (e.g., FDA, EMA).
• Stability Studies to track the formation of degradation products under various storage conditions.
• Research and Development of new synthetic routes and purification processes for Donepezil.

Basic Information

Product Name	Donepezil Impurity 7
CAS No.	197010-22-3
Molecular Formula	C24H29NO3
Molecular Weight	379.50 g/mol
Synonyms	Donepezil Related Compound 7; 2-[(1-Benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-3H-inden-1-one; 5,6-Dimethoxy-2-[(1-benzyl-4-piperidinyl)methyl]-1-indanone; 1-Indanone, 5,6-dimethoxy-2-[(1-benzyl-4-piperidinyl)methyl]-; Donepezil EP Impurity G; Donepezil USP Impurity 7
EINECS	Contact for details

Quality Control

Our Donepezil Impurity 7 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. Certificates of Analysis (COA) are provided, detailing all test results against established specifications. We support compliance with major pharmacopeial standards (USP, EP, JP) and ICH guidelines for impurities in new drug substances (Q3A(R2)).

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 hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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