Description

5-Hydroxy Omeprazole-(Pyridyl)-D3 is a deuterated analog and key synthetic intermediate of the widely used proton pump inhibitor, omeprazole. This compound is specifically designed for use in advanced pharmaceutical research and development, offering a stable isotopic label for precise metabolic and pharmacokinetic studies. It is an essential material for scientists in pharmaceutical development, contract research organizations (CROs), and analytical laboratories focused on drug metabolism, bioanalytical method development, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and identification of omeprazole metabolites in complex biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used as an internal standard in LC-MS/MS and GC-MS analyses to ensure accuracy and precision in measuring drug concentration levels.
• Impurity Profiling and Characterization: Critical for identifying and quantifying process-related impurities and degradants during drug substance and drug product development.
• Stable Isotope Labeling: The deuterium (D3) label provides a mass shift essential for distinguishing the compound from its non-deuterated counterpart in mass spectrometric analysis.
• Bioanalytical Method Development: Employed in the validation of analytical methods to meet regulatory requirements (e.g., FDA, EMA) for specificity, accuracy, and robustness.
• Clinical Research: Supports studies investigating the metabolic pathways and bioavailability of omeprazole and related compounds in human subjects.

Basic Information

Product Name	5-Hydroxy Omeprazole-(Pyridyl)-D3
CAS No.	1189882-58-3
Molecular Formula	C17H16D3N3O4S
Molecular Weight	362.44 g/mol
Synonyms	5-Hydroxy Omeprazole D3; 5-Hydroxy Omeprazole-(Pyridyl-d3); 6-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl-d3)methyl]sulfinyl]-1H-benzimidazol-5-ol; Deuterated 5-Hydroxy Omeprazole; Omeprazole Metabolite D3; Omeprazole 5-Hydroxy D3 Analog; 5-Hydroxy Omeprazole (Pyridyl Methyl-d3)
EINECS	Contact for details

Quality Control

Every batch of 5-Hydroxy Omeprazole-(Pyridyl)-D3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment. Our quality commitment aligns with the standards expected for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, isotopic purity, and related substances by validated methods such as HPLC, NMR, and MS.

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 material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98.0 atom % D
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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