Description

Lansoprazole Sulfone n-Oxide is a key pharmaceutical intermediate and analytical reference standard. This compound is of critical importance for quality control and research in the development and manufacturing of proton pump inhibitor medications. It is primarily utilized by pharmaceutical R&D laboratories, quality assurance departments, and manufacturers of active pharmaceutical ingredients (APIs) for analytical and synthetic purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity profiling of Lansoprazole API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical impurity marker in HPLC, UPLC, and LC-MS methods to ensure method specificity and sensitivity.
• Metabolite and Degradation Product Studies: Employed in research to study the metabolic pathways and stability profile of Lansoprazole.
• Process Chemistry & Impurity Control: Used to monitor and control the formation of specific sulfone n-oxide impurities during the synthesis of Lansoprazole.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require characterization of potential impurities.

Basic Information

Product Name	Lansoprazole Sulfone n-Oxide
CAS No.	953787-54-7
Molecular Formula	C16H14F3N3O4S
Molecular Weight	401.36 g/mol
Synonyms	Lansoprazole Sulfone N-Oxide; Lansoprazole Impurity (Sulfone N-Oxide); AGN 190935; 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole 5-Oxide; 1H-Benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-, 5-oxide; Lansoprazole Related Compound F (Sulfone N-Oxide); Lansoprazole Sulfone Oxide Impurity
EINECS	Contact for details

Quality Control

Our Lansoprazole Sulfone n-Oxide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results.

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 light-sensitive (store away from light).

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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