Description

Omeprazole D3 is a deuterium-labeled analog of the widely used proton pump inhibitor, omeprazole, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is essential for ensuring accuracy and reliability in mass spectrometry-based analyses, such as LC-MS/MS, by correcting for variations in sample preparation and instrument response. It is a critical tool for researchers and quality control laboratories in the pharmaceutical, clinical research, and forensic toxicology sectors who require precise quantification of omeprazole and its metabolites.

Application

• Internal Standard for Bioanalysis: Primary use as a stable isotope-labeled internal standard in the quantification of omeprazole in biological matrices (plasma, serum, urine) for pharmacokinetic and bioequivalence studies.
• Pharmaceutical R&D: Employed in drug metabolism and pharmacokinetics (DMPK) research to track the absorption, distribution, metabolism, and excretion (ADME) profile of omeprazole.
• Clinical Research: Used in clinical trials to accurately measure patient drug exposure and metabolic response, ensuring data integrity for regulatory submissions.
• Forensic and Toxicology Testing: Critical for the precise identification and quantification of omeprazole in forensic analyses and workplace drug testing programs.
• Method Development and Validation: Serves as a key component in developing, optimizing, and validating robust LC-MS/MS methods according to FDA, EMA, and ICH guidelines.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability-indicating assay methods for omeprazole active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	Omeprazole D3
CAS No.	934293-92-2
Molecular Formula	C17H16D3N3O3S
Molecular Weight	348.42 g/mol
Synonyms	5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)(D3)methyl]sulfinyl]-1H-benzimidazole; Omeprazole-d3; Deuterated Omeprazole; [2H3]-Omeprazole; 5-Methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)(trideuteriomethyl)sulfinyl]-1H-benzimidazole; (RS)-Omeprazole-d3
EINECS	Contact for details

Quality Control

Our Omeprazole D3 is manufactured under strict quality systems to ensure it meets the exacting requirements for analytical reference standards. Each batch undergoes comprehensive testing, including chromatographic purity (HPLC), isotopic enrichment (NMR/MS), and chemical identification. A detailed Certificate of Analysis (COA) is provided, documenting the purity, isotopic purity, and results of all specified tests to support your regulatory and research 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 compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an 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	≥ 99.0 atom % D
Chemical Purity	≥ 95.0%
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.