Description

Cisapridemonohydrate CAS NO 260779-88-2 is the monohydrate form of a benzamide derivative with prokinetic activity. This compound is a critical pharmaceutical intermediate and reference standard in the development and quality control of gastrointestinal motility agents. It is primarily required by pharmaceutical manufacturers and contract research organizations (CROs) for API synthesis, analytical method development, and regulatory compliance testing.

Application

• Pharmaceutical Active Ingredient (API) Synthesis: Serves as a key intermediate in the production of gastrointestinal prokinetic drugs.
• Reference Standard for QC/QA: Used as a high-purity standard in HPLC, LC-MS, and other analytical methods to assay drug products and raw materials.
• Pharmacological Research: Employed in preclinical and clinical studies investigating serotonin (5-HT4) receptor agonists and gastrointestinal motility.
• Impurity Profiling: Essential for identifying and quantifying related substances and degradation products in compliance with ICH guidelines.
• Formulation Development: Used in stability studies and the development of solid dosage forms such as tablets.
• Regulatory Submissions: Provides certified material for generating data required by FDA, EMA, and other global health authorities.

Basic Information

Product Name	Cisapridemonohydrate
CAS No.	260779-88-2
Molecular Formula	C23H29ClFN3O4 • H2O
Molecular Weight	483.95 g/mol (monohydrate)
Synonyms	Cisapride Monohydrate; (±)-cis-4-Amino-5-chloro-N-[1-[3-(4-fluorophenoxy)propyl]-3-methoxy-4-piperidinyl]-2-methoxybenzamide Monohydrate; R 51619 Monohydrate; Prepulsid (trade name); Alimix; Acenalin; Prizma; Unipride
EINECS	Contact for details

Quality Control

Our Cisapridemonohydrate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure it meets stringent specifications suitable for pharmaceutical R&D. A Certificate of Analysis (COA) detailing all test results against relevant pharmacopeial standards (e.g., USP, EP) is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	3.0% - 4.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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