Description

Mosapride Citrate Dihydrate is a high-purity pharmaceutical active ingredient, specifically the citrate salt dihydrate form of the gastroprokinetic agent mosapride. This compound is critical for ensuring the precise formulation and consistent therapeutic efficacy of finished pharmaceutical products. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of medications targeting gastrointestinal motility disorders.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of prescription drugs for functional dyspepsia and gastroesophageal reflux disease (GERD).
• Reference Standard for analytical method development and validation in quality control laboratories.
• Pharmaceutical Research & Development for studying 5-HT4 receptor agonists and developing new gastrointestinal therapeutics.
• Formulation Studies for creating various dosage forms such as tablets, capsules, and orally disintegrating films.
• Clinical Trial Material for use in Phase I-III studies of new mosapride-based formulations.
• Contract Manufacturing for generic drug producers requiring a reliable source of high-grade API.

Basic Information

Product Name	Mosapride Citrate Dihydrate
CAS No.	636582-62-2
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; Mosapride citrate hydrate; GM-611 citrate dihydrate; AS-4370 citrate dihydrate; Gasmotin (brand name) citrate salt; (R,S)-Mosapride 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 stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to prevent degradation. The container should be kept tightly sealed when not in use.

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%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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