Description

Lansoprazole Sulfone is a key pharmaceutical intermediate and analytical reference standard. This compound is of significant importance for quality control and research in the development of proton pump inhibitors. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for synthesis, impurity profiling, and method validation.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis and research of proton pump inhibitor drugs.
• Analytical Reference Standard: Used for the identification, assay, and impurity testing of Lansoprazole and related compounds in HPLC, LC-MS, and other analytical methods.
• Impurity Standard: Serves as a certified reference material (CRM) for quantifying the sulfone impurity in Lansoprazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research for Lansoprazole.
• Method Development & Validation: Essential for developing and validating stability-indicating assay methods in pharmaceutical quality control laboratories.
• Regulatory Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing a characterized impurity for stability and specification documentation.

Basic Information

Product Name	Lansoprazole Sulfone
CAS No.	131926-99-3
Molecular Formula	C16H14F3N3O3S
Molecular Weight	385.36 g/mol
Synonyms	2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfonyl]-1H-benzimidazole; AG-1812; Lansoprazole Sulfoxide Impurity; Lansoprazole Related Compound C; Lansoprazole EP Impurity C; Lansoprazole Sulfone Impurity
EINECS	Contact for details

Quality Control

Our Lansoprazole Sulfone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.