Description

Donepezil Impurity-Oh CAS NO 148517-82-2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Donepezil hydrochloride, a key acetylcholinesterase inhibitor. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves 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: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure drug substance and product purity meets stringent pharmacopeial (USP, EP, JP) and ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry research to understand degradation pathways and to develop purer synthetic routes for Donepezil.

Basic Information

Product Name	Donepezil Impurity-Oh
CAS No.	148517-82-2
Molecular Formula	C24H29NO3
Molecular Weight	379.50 g/mol
Synonyms	Donepezil Impurity O; Donepezil Related Compound O; 2-[(1-Benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-1H-inden-1-one; 1H-Inden-1-one, 2-[(1-benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-; ARIP 1 Impurity O; E2020 Impurity O
EINECS	Contact for details

Quality Control

Every batch of Donepezil Impurity-Oh is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards and customer-specific requirements. 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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

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)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.