Description

5-Hydroxy Omeprazole-D3 is a deuterium-labeled isotopologue of a key omeprazole metabolite, essential for advanced analytical and research applications. This high-purity reference standard is critical for ensuring accuracy and reliability in quantitative mass spectrometry and pharmacokinetic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers for method development, validation, and bioanalytical testing.

Application

• Internal Standard for LC-MS/MS: Serves as a stable isotope-labeled internal standard for the precise quantification of 5-hydroxy omeprazole and related compounds in complex biological matrices like plasma and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in tracer studies to investigate the metabolic pathways, bioavailability, and clearance rates of omeprazole and its derivatives.
• Bioanalytical Method Development: Enables the creation and validation of highly specific and sensitive analytical methods in compliance with FDA and ICH guidelines.
• Clinical Research: Supports therapeutic drug monitoring and comparative bioavailability/bioequivalence studies for proton pump inhibitor formulations.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of metabolite-related impurities in active pharmaceutical ingredient (API) batches.
• Academic Research: Facilitates fundamental research in gastroenterology and cytochrome P450 enzyme activity related to acid suppression therapies.

Basic Information

Product Name	5-Hydroxy Omeprazole-D3
CAS No.	1216667-13-8
Molecular Formula	C17H16D3N3O3S
Molecular Weight	Approx. 346.41 g/mol
Synonyms	5-Hydroxy Omeprazole-d3; 5-Hydroxy-OMZ-d3; 6-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl-d3)methyl]sulfinyl]-1H-benzimidazol-5-ol; Deuterated 5-Hydroxy Omeprazole; 5-Hydroxy Omeprazole (D3 Labeled); Omeprazole Metabolite D3; 5-OH Omeprazole-d3
EINECS	Contact for details

Quality Control

Every batch of 5-Hydroxy Omeprazole-D3 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support your regulatory submissions, including Certificates of Analysis (COA) detailing purity, isotopic enrichment, and impurity profiles. Our quality commitment ensures the material meets the stringent requirements for use as a certified reference standard in regulated environments.

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 must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (D3)	≥98.0 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.