Description

Mosapride n-Oxide is a key pharmaceutical intermediate and metabolite of the gastroprokinetic agent Mosapride. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of related active pharmaceutical ingredients (APIs). It serves as a critical reference standard and building block for manufacturers and research institutions focused on gastrointestinal therapeutics and analytical method development.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Mosapride and its metabolites in biological matrices and finished drug products.
• Metabolite Research: Essential for conducting ADME (Absorption, Distribution, Metabolism, and Excretion) studies to understand the metabolic pathway and safety profile of Mosapride.
• Active Pharmaceutical Ingredient (API) Synthesis: Serves as a sophisticated intermediate in the multi-step synthesis of Mosapride Citrate and other related benzamide derivatives.
• Analytical Method Development: Critical for developing and validating high-performance liquid chromatography (HPLC), LC-MS, and other chromatographic methods in quality control laboratories.
• Pharmacology Studies: Employed in preclinical and clinical research to investigate the pharmacological activity and potency of Mosapride's oxidative metabolites.
• Impurity Profiling: Used to identify, quantify, and control process-related impurities and degradation products in Mosapride drug substance and drug product manufacturing.

Basic Information

Product Name	Mosapride n-Oxide
CAS No.	1161443-73-7
Molecular Formula	C21H25ClFN3O4
Molecular Weight	437.89 g/mol
Synonyms	4-Amino-5-chloro-2-ethoxy-N-[[4-[(4-fluorobenzyl)-2-oxo-1,3-oxazolidin-3-yl]methyl]phenyl]benzamide N-Oxide; Mosapride N-Oxide; Mosapride Impurity; Mosapride Metabolite; GM-1097 N-Oxide; Mosapride Related Compound
EINECS	Contact for details

Quality Control

Our Mosapride n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical research and development. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. Our quality commitment aligns with cGMP principles for advanced intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and should be handled under an inert atmosphere for long-term storage 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
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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