Description

Lansoprazole Sulfone-D4 CAS NO 1184999-77-6 is a deuterium-labeled analog of lansoprazole sulfone, a key metabolite and impurity of the proton pump inhibitor lansoprazole. This high-purity, isotopically labeled compound is an essential reference standard for ensuring the accuracy and reliability of analytical methods in pharmaceutical research and quality control. It is primarily used by analytical chemists and researchers in the pharmaceutical industry for applications such as quantitative bioanalysis, pharmacokinetic studies, and impurity profiling.

Application

• Internal Standard for LC-MS/MS Analysis: Used as a stable isotope-labeled internal standard for the precise quantification of lansoprazole and its metabolites in complex biological matrices like plasma and urine.
• Metabolite Reference Material: Serves as a certified reference standard for the identification and characterization of lansoprazole sulfone during drug metabolism and pharmacokinetic (DMPK) studies.
• Pharmaceutical Impurity Profiling: Employed in the development and validation of HPLC and UPLC methods to monitor and control lansoprazole sulfone as a specified impurity in active pharmaceutical ingredient (API) and finished product batches.
• Method Development and Validation: Critical for developing robust analytical methods that comply with ICH Q2(R1) guidelines, ensuring specificity, accuracy, and precision.
• Doping Control and Forensic Analysis: Can be utilized as a reference compound in specialized testing laboratories.
• Stable Isotope Tracer Studies: Facilitates advanced research into the metabolic pathways and disposition of lansoprazole within biological systems.

Basic Information

Product Name	Lansoprazole Sulfone-D4
CAS No.	1184999-77-6
Molecular Formula	C16H10D4F3N3O3S
Molecular Weight	373.38 g/mol
Synonyms	2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole-d4 Sulfone; Lansoprazole Sulfone-d4; Deuterated Lansoprazole Sulfone; [2H4]-Lansoprazole Sulfone; AG-1749 Sulfone-d4; (RS)-Lansoprazole Sulfone-d4; Lansoprazole EP Impurity D-d4; Lansoprazole-d4 Sulfone
EINECS	Contact for details

Quality Control

Our Lansoprazole Sulfone-D4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR, HPLC, and MS, to confirm chemical identity, isotopic purity (D-enrichment ≥98%), and chemical purity. We provide full traceability and Certificates of Analysis (COA) detailing all test results, including assay, impurity profile, and residual solvent analysis, ensuring compliance with the standards required for pharmaceutical reference materials.

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 compound is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccant 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 (D-enrichment)	≥98 atom % D
Chemical Purity (NMR)	≥95%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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