Description

Lansoprazole-D4 n-Oxide is a deuterated derivative of the lansoprazole metabolite, Lansoprazole N-Oxide, specifically designed for use as an internal standard in analytical chemistry. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry methods, particularly in pharmacokinetic and metabolic studies. It is a critical material for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units requiring precise and stable isotopic labeling for method validation and regulatory compliance.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, non-interfering internal standard for the accurate quantification of lansoprazole and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmaceutical Metabolism Studies: Used in ADME (Absorption, Distribution, Metabolism, and Excretion) studies to track and quantify the metabolic pathway of lansoprazole, specifically the N-oxidation route.
• Bioanalytical Method Development & Validation: Critical for developing, validating, and transferring robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Research: Enables precise measurement of drug concentration over time in clinical and pre-clinical trials.
• Doping Control & Forensic Analysis: Potential use as a reference standard in specialized testing for prohibited substances.
• Quality Control in API Manufacturing: Serves as a reference standard for monitoring impurities and related substances in active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	Lansoprazole-D4 n-Oxide
CAS No.	1346604-20-3
Molecular Formula	C16H10D4F3N3O3S
Molecular Weight	373.39 g/mol
Synonyms	Lansoprazole D4 N-Oxide; 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole-d4 1-Oxide; Deuterated Lansoprazole N-Oxide; Lansoprazole (D4) N-Oxide; Lansoprazole N-Oxide-d4; (RS)-Lansoprazole-D4 N-Oxide; AG-1749 D4 N-Oxide; Internal Standard for Lansoprazole N-Oxide
EINECS	Contact for details

Quality Control

Our Lansoprazole-D4 n-Oxide is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and related substances. We adhere to relevant industry standards for reference materials, and our quality commitment supports compliance with GMP, ICH Q7, and ISO 17034 guidelines for reference material producers.

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. For long-term storage, consider desiccated conditions.

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 (D4)	≥ 98.0 atom % D
Related Substances (HPLC)	Total impurities ≤ 2.0%
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.