Description

5-o-Desmethyl Donepezil-D5 is a deuterated internal standard of a key donepezil metabolite, essential for precise quantitative analysis in pharmacokinetic and bioanalytical studies. This high-purity reference material is critical for ensuring the accuracy and reliability of mass spectrometry-based assays, particularly in regulated environments. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities focused on drug metabolism and therapeutic drug monitoring for Alzheimer's disease treatments.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable isotope-labeled internal standard for the accurate quantification of 5-o-desmethyl donepezil in biological matrices (plasma, serum, urine).
• Pharmacokinetic (PK) Studies: Enables precise measurement of metabolite concentration-time profiles to understand the absorption, distribution, metabolism, and excretion (ADME) of donepezil.
• Bioanalytical Method Development & Validation: Used as a critical component in developing and validating robust, GLP/GCP-compliant analytical methods for clinical and preclinical trials.
• Therapeutic Drug Monitoring (TDM): Supports assays designed to monitor donepezil and its metabolite levels in patients to optimize dosing regimens and efficacy.
• Drug Metabolism Research: Facilitates studies on the metabolic pathways and enzymatic processes involved in donepezil biotransformation.
• Impurity Profiling and Characterization: Serves as a reference marker in the identification and quantification of related substances in active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	5-o-Desmethyl Donepezil-D5
CAS No.	1189929-21-2
Molecular Formula	C23H22D5NO3
Molecular Weight	~ 384.51 g/mol
Synonyms	5-O-Desmethyl Donepezil-d5; Donepezil Metabolite-d5; 2-[(1-Benzyl-4-piperidinyl)methyl]-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one-d5 (O-Desmethyl); 1-Benzyl-4-[(5,6-dimethoxy-1-oxo-2,3-dihydro-1H-inden-2-yl)methyl]piperidine-d5 (O-Desmethyl); (±)-2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one-d5 (O-Desmethyl); AR-R 15896-d5; E2020 metabolite-d5.
EINECS	Contact for details

Quality Control

Our 5-o-Desmethyl Donepezil-D5 is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for analytical applications. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity (by HPLC), isotopic purity (D-content), and identity confirmation, supporting compliance with GLP and ICH Q2(R1) guidelines for analytical procedures.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity	≥ 95%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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