Description

Mosapride Citrate Dihydrate is a high-purity pharmaceutical active ingredient, specifically a selective 5-HT4 receptor agonist. This compound is critical for the formulation of gastrointestinal prokinetic agents, offering a targeted mechanism of action. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for functional dyspepsia, gastroesophageal reflux disease (GERD), and other gastrointestinal motility disorders.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of oral solid dosage forms such as tablets and capsules for gastrointestinal disorders.
• Research & Development: Serves as a key reference standard and intermediate in pharmacological studies and new drug development projects.
• Generic Drug Manufacturing: Essential for companies producing generic versions of gastroprokinetic medications containing Mosapride.
• Veterinary Medicine: Potential application in veterinary pharmaceuticals for treating digestive issues in animals.
• Clinical Trial Material: Supplied as a qualified material for use in Phase I-III clinical trials for gastrointestinal therapeutics.
• Analytical Testing: Used as a certified reference material (CRM) in quality control laboratories for assay validation and impurity profiling.

Basic Information

Product Name	Mosapride Citrate Dihydrate
CAS No.	156925-25-6
Molecular Formula	C21H25ClFN3O3 • C6H8O7 • 2H2O
Molecular Weight	650.04 g/mol
Synonyms	4-Amino-5-chloro-2-ethoxy-N-[[4-[(4-fluorophenyl)methyl]-2-morpholinyl]methyl]benzamide citrate dihydrate; GM-611 Citrate Dihydrate; Mosapride Citrate Hydrate; (+-)-4-Amino-5-chloro-2-ethoxy-N-[[4-[(4-fluorophenyl)methyl]-2-morpholinyl]methyl]benzamide citrate dihydrate; Benzamide, 4-amino-5-chloro-2-ethoxy-N-[[4-[(4-fluorophenyl)methyl]-2-morpholinyl]methyl]-, citrate, dihydrate
EINECS	Contact for details

Quality Control

Our Mosapride Citrate Dihydrate is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide comprehensive Certificates of Analysis (COA) detailing identity, purity, and impurity profiles. The product is typically characterized against relevant pharmacopeial standards, and custom synthesis to meet specific customer specifications is available upon request.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	5.0% - 7.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Solubility	Freely soluble in water, slightly soluble in ethanol

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