Description

Prucalopride Succinate is a high-purity active pharmaceutical ingredient (API) used as a selective serotonin 5-HT4 receptor agonist. This compound is critical for the formulation of prescription medications designed to treat chronic constipation disorders by enhancing colonic motility. It is essential for pharmaceutical manufacturers and research institutions developing and producing gastrointestinal therapeutics.

Application

• Pharmaceutical API: Primary active ingredient in prescription drugs for chronic idiopathic constipation (CIC).
• Drug Formulation R&D: Used in the research and development of new solid oral dosage forms, such as tablets and capsules.
• Clinical Trial Material: Serves as the key component in manufacturing supplies for clinical studies and bioequivalence testing.
• Reference Standard: Employed as a high-purity analytical standard in quality control laboratories for HPLC and other assay methods.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for commercial-scale drug production.
• Mechanistic Studies: Utilized in pharmacological research to study 5-HT4 receptor function and gastrointestinal physiology.

Basic Information

Product Name	Prucalopride Succinate
CAS No.	179474-85-2
Molecular Formula	C21H26ClN3O3 • C4H6O4
Molecular Weight	485.94 g/mol (for succinate salt)
Synonyms	Prucalopride hydrogen succinate; R 093877; R-093877; Resolor; Motegrity; 4-Amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide succinate; UNII-6M9P6U6Q3B; 1H-Benzofuro[3,2-c]pyridine-7-carboxamide, 4-amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidinyl]-, butanedioate (1:1)
EINECS	Contact for details

Quality Control

Our Prucalopride Succinate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH Q7 guidelines for active pharmaceutical ingredients. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Specific Rotation	Contact for details

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