Description

n-(4-Methoxy-3,5-Dimethyl-2-Pyridinyl)Methyl Omeprazole-D3 Sulfone is a deuterium-labeled, oxidized metabolite derivative of omeprazole, specifically designed for use as an internal standard in quantitative bioanalytical assays. This compound delivers exceptional isotopic fidelity and chromatographic stability, enabling highly accurate and reproducible LC-MS/MS measurements of omeprazole and its metabolites in complex biological matrices. It is essential for pharmaceutical R&D, clinical pharmacokinetic studies, and regulatory bioequivalence testing where precise quantification and method robustness are non-negotiable.

Application

• Internal standard for LC-MS/MS quantification of omeprazole and related sulfone metabolites in human plasma, serum, and urine
• Reference material for method validation (accuracy, precision, recovery, matrix effect assessment) in GLP-compliant bioanalytical laboratories
• Calibration standard in pharmacokinetic and ADME (Absorption, Distribution, Metabolism, Excretion) studies during preclinical and clinical drug development
• Quality control reference for stability-indicating assays evaluating omeprazole degradation pathways under oxidative stress conditions
• Tool compound for mechanistic enzymology studies involving CYP2C19 and CYP3A4-mediated omeprazole metabolism
• Supporting reagent in the development and verification of UHPLC-MS/MS methods compliant with FDA Bioanalytical Method Validation Guidance

Basic Information

Product Name	n-(4-Methoxy-3,5-Dimethyl-2-Pyridinyl)Methyl Omeprazole-D3 Sulfone
CAS No.	1346603-82-4
Molecular Formula	C18H18D3N3O4S
Molecular Weight	392.47 g/mol
Synonyms	Omeprazole-d3 sulfone; Omeprazole-D3 sulfone; [D3]-Omeprazole sulfone; n-(4-Methoxy-3,5-dimethylpyridin-2-yl)methyl [D3]-omeprazole sulfone; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-d3 sulfone; Omeprazole sulfone-d3; Omeprazole-13C, D3 sulfone; Omeprazole-d3 sulphone
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is verified for isotopic enrichment (≥99% D at designated positions), chemical purity (≥98.5% by HPLC), identity (IR and 1H NMR), and absence of critical impurities (e.g., residual solvents, heavy metals). Testing aligns with ICH Q2(R2) guidelines and supports compliance with FDA, EMA, and PMDA bioanalytical method validation requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (argon or nitrogen) to prevent degradation. Due to its hygroscopic nature, maintain low-humidity conditions (<30% RH) and minimize exposure to ambient air during handling.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Isotopic Purity (MS)	≥99% D at benzylic and pyridyl methyl positions
Related Substances (HPLC)	≤1.0% total impurities
Residual Solvents (GC)	Meets ICH Q3C limits
Water (Karl Fischer)	≤0.5%

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