Description

Lansoprazole n-Oxide is a key pharmaceutical intermediate and impurity standard in the synthesis and quality control of proton pump inhibitors. This compound is of critical importance for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) in gastrointestinal therapeutics. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on drug development and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Lansoprazole and related proton pump inhibitor APIs.
• Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other analytical methods to quantify and control related substances in drug substances and products.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research to study the biotransformation of Lansoprazole.
• Quality Control & Assurance: Essential for establishing and validating impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing characterized impurity material.
• Research & Development: Utilized in medicinal chemistry for the design and development of new acid-suppressive agents.

Basic Information

Item	Detail
Product Name	Lansoprazole n-Oxide
CAS No.	213476-12-1
Molecular Formula	C16H14F3N3O3S
Molecular Weight	401.36 g/mol
Synonyms	Lansoprazole N-Oxide; Lansoprazole Impurity F (EP); Lansoprazole Related Compound F; 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole 1-Oxide; AG-1749 N-Oxide; (RS)-Lansoprazole N-Oxide; Lansoprazole EP Impurity F; Lansoprazole USP Related Compound F
EINECS	Contact for details

Quality Control

Our Lansoprazole n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with EP, USP, and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.