Mosapride
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 C21H25ClFN3O3, 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.
References
FAQ's
References
- Kon, Tatsuya; Kato, Shiro; Morie, Toshiya; Ohno, Kazunori; Hino, Katsuhiko; Karasawa, Tadahiko; Yoshida, Naoyuki, Substituted Benzamide Derivatives, Processes For The Preparation Thereof, And Pharmaceutical Compositions Containing The Same, Dainippon Pharmaceutical Co., Ltd., Japan, EP243959B1, August 19, 1992
- Kumar, Y. Ravindra; Moses Babu, J.; Sarma, M. S. P.; Seshidhar, B.; Reddy, S. Srinivasa; Reddy, G. Sudarsan; Vyas, K., Application of LC-MS/MS for the identification of a polar impurity in mosapride, a gastroprokinetic drug, Journal of Pharmaceutical and Biomedical Analysis, Volume: 32, Issue: 2, Pages: 361-368, 2003
Frequently Asked Questions
Can Mosapride impurities lead to drug interactions?
Impurities in Mosapride are monitored closely to minimize the potential for interactions with other medications.
How are limits of Mosapride impurities determined?
Impurity limits in Mosapride are established based on scientific research, toxicological evaluations, and regulatory guidelines to ensure the safety and quality of the medication.
Which solvent helps in analyzing Mosapride impurities?
Methanol or Acetonitrile is the solvent used when analyzing many impurities in Mosapride.
What is the recommended storage temperature for Mosapride impurities?
Mosapride impurities should be stored, at a controlled room temperature, usually between 2-8 °C.
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