Description

Donepezil Impurity 17 Hcl is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Donepezil hydrochloride, a key medication for Alzheimer's disease. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Donepezil Impurity 17 in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC laboratories to establish specification limits and ensure every batch of Donepezil HCl meets stringent purity requirements.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) to determine drug product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory agencies like the FDA and EMA.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Donepezil Impurity 17 Hcl
CAS No.	2217617-87-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Donepezil Related Compound 17 Hydrochloride; Donepezil HCl Impurity 17; Donepezil Hydrochloride Impurity 17; Donepezil EP Impurity 17 HCl; Donepezil USP Impurity 17 HCl; (R)-2-((1-Benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one Hydrochloride (tentative); 1H-Inden-1-one, 2,3-dihydro-5,6-dimethoxy-2-[[(1R)-1-(phenylmethyl)-4-piperidinyl]methyl]-, hydrochloride (1:1)
EINECS	Contact for details

Quality Control

Our Donepezil Impurity 17 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request. Production can be aligned with relevant pharmacopeial standards (USP, EP) as required.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C. This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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