General Information

Mosapride Impurities and Mosapride  

For evaluating the purity and safety of Mosapride, an essential active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Mosapride impurity standards. These impurity standards include crucial compounds such as 3,5-Dichloro Mosapride, Des-chloro-Mosapride, Mosapride Citric Amide,  Mosapride N-Oxide etc. Additionally, Daicel Pharma provides worldwide delivery options for Mosapride impurity standards.

Used in treating acid reflux, irritable bowel syndrome, and functional dyspepsia, Mosapride [CAS: 112885-41-3] acts as a selective 5HT4 agonist, functioning as a gastroprokinetic agent to accelerate gastric emptying.

Mosapride: Use and Commercial Availability  

Mosapride, marketed under brand names like Kinetix, M-Pride, Mic, Mosafe, etc., is a gastroprokinetic agent that is a selective 5HT4 agonist. It accelerates gastric emptying and intestinal transit, providing therapeutic benefits for gastritis, gastroesophageal reflux disease, functional dyspepsia, and irritable bowel syndrome. Furthermore, its major active metabolite, M1, acts as a 5HT3 antagonist. Mosapride also exhibits anti-inflammatory effects on the gastrointestinal tract.

Mosapride Structure and Mechanism of Action

The chemical name of Mosapride is 4-Amino-5-chloro-2-ethoxy-N-[[4-[(4-fluorophenyl)methyl]-2-morpholinyl]methyl]benzamide. Its chemical formula is C₂₁H₂₅ClFN₃O_3, and its molecular weight is approximately 421.9 g/mol.

Mosapride acts on 5HT4 receptors in the gastrointestinal plexus and increases acetylcholine release. It promotes neurogenesis in the gastrointestinal tract.

Mosapride Impurities and Synthesis

As with any chemical compound, Mosapride can contain impurities that may arise during its synthesis¹ or storage. They can include related substances, residual solvents, and degradation products. Regulatory guidelines provide limits for these impurities to ensure product quality and safety. Manufacturers employ stringent quality control measures and analytical techniques to monitor and control impurity levels in Mosapride. By adhering to these guidelines, they can maintain Mosapride efficacy, purity, and safety for patient use. Continuous monitoring and rigorous quality assurance procedures help ensure that Mosapride is good quality and suitable for its intended therapeutic use.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for the preparation of Mosapride impurity standards, which include 3,5-Dichloro Mosapride, Des-chloro-Mosapride, Mosapride Citric Amide, and Mosapride N-Oxide. Mosapride impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we give additional data like 13C-DEPT. Moreover, we can synthesize unknown Mosapride impurity standards and degradation products. Each delivery has a comprehensive characterization report, ensuring quality and transparency.