Description

Lansoprazole-D4 Sulfone n-Oxide is a high-purity, stable isotope-labeled derivative of the proton pump inhibitor Lansoprazole. This compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in mass spectrometry-based analyses. It is an essential tool for pharmaceutical research and development, clinical laboratories, and contract research organizations (CROs) engaged in drug metabolism and pharmacokinetic (DMPK) studies, therapeutic drug monitoring, and bioequivalence testing.

Application

• Internal Standard for LC-MS/MS: Primary application as a deuterated internal standard for the precise quantification of Lansoprazole and its metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism Studies (DMPK): Critical for investigating the metabolic pathways, pharmacokinetics, and bioavailability of Lansoprazole in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Used to develop, optimize, and validate robust, regulatory-compliant analytical methods for pharmaceutical analysis.
• Therapeutic Drug Monitoring (TDM): Enables accurate measurement of drug concentrations in patient samples to optimize dosing regimens and ensure therapeutic efficacy.
• Impurity Profiling and Reference Standard: Serves as a certified reference material for identifying and characterizing related substances and degradation products in active pharmaceutical ingredient (API) batches.
• Clinical Research & Bioequivalence Trials: Provides the analytical precision required for critical studies comparing generic and innovator drug formulations.

Basic Information

Product Name	Lansoprazole-D4 Sulfone n-Oxide
CAS No.	1190009-70-1
Molecular Formula	C16H10D4F3N3O4S
Molecular Weight	389.38 g/mol
Synonyms	Lansoprazole D4 Sulfone N-Oxide; 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole-d4 Sulfone N-Oxide; AG-1749-d4 Sulfone N-Oxide; Lansoprazole-d4 Sulfoxide Metabolite Standard; Deuterated Lansoprazole Sulfone N-Oxide; (RS)-Lansoprazole-d4 Sulfone N-Oxide; Proton Pump Inhibitor-d4 Metabolite Standard
EINECS	Contact for details

Quality Control

Every batch of Lansoprazole-D4 Sulfone n-Oxide is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity to meet the exacting demands of quantitative analysis. Comprehensive testing includes identity confirmation (NMR, MS), assay (HPLC), and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This compound is hygroscopic (moisture-sensitive); the container should be allowed to reach room temperature before opening to minimize condensation and exposure to atmospheric moisture.

Specification

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