Description

Donepezil Benzyl Bromide (Donepezil Impurity) is a key chemical reference standard and synthetic intermediate used in the development and quality control of the active pharmaceutical ingredient donepezil hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control process-related impurities, ensuring the safety and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in donepezil hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the manufacturing process.
• Process Chemistry Research: Serves as a critical intermediate or marker in studying and optimizing the synthetic pathway for donepezil.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Quality Control Testing: Employed in routine batch release testing to ensure API purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation impurities in donepezil formulations under various storage conditions.

Basic Information

Product Name	Donepezil Benzyl Bromide (Donepezil Impurity)
CAS No.	844694-85-5
Molecular Formula	C24H26BrNO2
Molecular Weight	440.38 g/mol
Synonyms	1-Benzyl-4-[(5,6-dimethoxy-1-indanon-2-yl)methyl]piperidinium Bromide; Donepezil Benzyl Bromide Impurity; Donepezil Related Compound; (RS)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-indanone Benzyl Bromide; Aricept Impurity; E2020 Benzyl Bromide; 2-[(1-Benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-1H-inden-1-one Hydrobromide Benzyl; 5,6-Dimethoxy-2-((1-(phenylmethyl)-4-piperidinyl)methyl)-1-indanone Hydrobromide Benzyl Salt
EINECS	Contact for details

Quality Control

Our Donepezil Benzyl Bromide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

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 product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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