Description

Lansoprazole Sulfide-D4 is a deuterium-labeled analog of a key intermediate in the synthesis of the proton pump inhibitor Lansoprazole. This stable isotope-labeled compound is essential for conducting high-precision pharmacokinetic and metabolic studies, providing critical data for drug development and regulatory compliance. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical reference standard manufacturers engaged in bioanalytical method development and mass spectrometry-based quantification.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard in the quantitative bioanalysis of Lansoprazole and its metabolites in biological matrices like plasma and urine.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in absorption, distribution, metabolism, and excretion (ADME) studies to track the metabolic pathways and bioavailability of the parent drug.
• Pharmaceutical Impurity Profiling: Acts as a reference marker in the identification and quantification of process-related impurities and degradation products during drug substance manufacturing.
• Stable Isotope Labeling Studies: Enables precise mechanistic studies in medicinal chemistry and pharmacology by tracing the fate of specific molecular fragments.
• Clinical Research Support: Facilitates accurate drug monitoring in clinical trials, ensuring reliable data for safety and efficacy evaluations.
• Regulatory Submission Support: Provides the validated reference materials required for method development and documentation in FDA, EMA, and other global regulatory agency submissions.

Basic Information

Product Name	Lansoprazole Sulfide-D4
CAS No.	1216682-38-0
Molecular Formula	C16H10D4F3N3O2S
Molecular Weight	369.39 g/mol
Synonyms	2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole-d4; AG-1749 Sulfide-d4; (RS)-Lansoprazole Sulfide-d4; Deuterated Lansoprazole Sulfide; Lansoprazole-d4 Sulfide; Lansoprazole Sulfide (Deuterated); Lansoprazole Related Compound D-d4
EINECS	Contact for details

Quality Control

Our Lansoprazole Sulfide-D4 is manufactured under strict quality control protocols to ensure the high chemical and isotopic purity required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and residual solvents. We adhere to cGMP principles for the production of reference standards, supporting our commitment to reliability and traceability for critical research and development work.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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 (D-content)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Residual Solvents (GC)	Complies with ICH limits

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