Description

n-(4-Methoxy-3,5-Dimethyl-2-Pyridinyl)Methyl Omeprazole-D3 is a deuterated analog of the active pharmaceutical ingredient omeprazole, specifically designed for use as an internal standard in analytical chemistry. This compound is critical for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and bioequivalence studies. It is an essential tool for pharmaceutical research and development laboratories, contract research organizations (CROs), and quality control departments that require high-purity reference materials for mass spectrometry and HPLC methods.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable isotope-labeled internal standard for the precise quantification of omeprazole and related compounds in biological matrices like plasma and serum.
• Pharmaceutical R&D: Used in drug metabolism and pharmacokinetics (DMPK) studies to track the absorption, distribution, metabolism, and excretion (ADME) of proton pump inhibitors.
• Bioanalytical Method Development: Essential for developing and validating robust, sensitive, and specific analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Enables accurate measurement of drug concentrations in patient samples during clinical trials for bioequivalence and therapeutic drug monitoring.
• Impurity Profiling and Characterization: Aids in the identification and quantification of process-related impurities and degradation products in drug substance and product analysis.
• Metabolite Studies: Facilitates the investigation and quantification of omeprazole metabolites in complex biological systems.

Basic Information

Product Name	n-(4-Methoxy-3,5-Dimethyl-2-Pyridinyl)Methyl Omeprazole-D3
CAS No.	1346599-69-6
Molecular Formula	C17H16D3N3O3S
Molecular Weight	346.44 g/mol
Synonyms	Omeprazole-d3 (Pyridinylmethyl Derivative); 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-d3; Deuterated Omeprazole Internal Standard; (R,S)-Omeprazole-d3; 5-Methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-1,3-benzodiazole-d3; Losec-d3; Prilosec-d3
EINECS	Contact for details

Quality Control

Our deuterated standards are produced under strict quality management systems to ensure the highest isotopic purity and chemical integrity. Each batch undergoes comprehensive analysis using advanced techniques including NMR, HPLC, and mass spectrometry to confirm identity, purity, and isotopic enrichment. A detailed Certificate of Analysis (COA) is provided, documenting the results for critical parameters such as assay, isotopic purity (D3 content), and related substances. Our quality commitment aligns with the needs of GMP/GLP-compliant laboratories.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 99.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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