Prucalopride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Prucalopride USP/EP

High-purity pharmaceutical grade Prucalopride manufactured under stringent cGMP conditions. This 5-HT4 receptor agonist API is essential for chronic constipation treatment, particularly in gastrointestinal motility enhancement, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • 5-HT4 Receptor Agonist for Motility
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C18H26ClN3O3
CAS Number: 179474-81-8
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 367.87 g/mol
Melting Point: 145-150°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Soluble in water and methanol
Storage Conditions: Store at 15-30°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 100g, 500g, 1kg containers

Applications

Chronic Constipation
Gastrointestinal Motility
Oral Tablet Formulations
Extended-Release Tablets
IBS-C Treatment
5-HT4 Receptor Agonist
Functional Constipation
Adult Constipation Management
Gastroenterology Research
Clinical Trials
GI Drug Development
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Prucalopride grades tailored for specific gastrointestinal applications, ensuring optimal 5-HT4 receptor agonist activity and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: GI research studies
Oral Formulation Grade
Purity: ≥99.5% Particle Size: Controlled Bioavailability: Optimized Application: Oral dosage forms

Quality Standards

DRAVYOM's Prucalopride is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for gastrointestinal therapy applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
5-HT4 Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Prucalopride exhibits exceptional 5-HT4 receptor agonist properties essential for gastrointestinal applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding prokinetic formulations.

Molecular Properties
Molecular Weight: 367.85 g/mol
LogP: 1.8
pKa: 8.9
Bioavailability: ~90%
Physical Properties
Melting Point: 138-142°C
Solubility (Water): 5.4 mg/mL
Crystalline Form: Stable succinate salt
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
5-HT4 EC50: 2.5 nM
Prokinetic Effect: Potent
Selectivity: 5-HT4 selective
Stability: Stable in formulations
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Not light sensitive
Temperature Stability: Room temperature stable
pH Stability: Stable pH 4-8

Performance Characteristics

Detailed performance metrics demonstrate Prucalopride superiority in gastrointestinal applications with exceptional 5-HT4 receptor activation, prokinetic effects, and reproducibility across diverse constipation treatment formulations.

5-HT4 Activation

EC50: 2.5 nM receptor activation

Potent prokinetic activity
Bioavailability

Oral: ~90% bioavailability

Excellent drug absorption
Stability

Solid state: >3 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-30°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

3 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade gastrointestinal API requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for pharmaceutical APIs and ensure proper waste disposal procedures.

Pharmaceutical API
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from moisture. Keep containers tightly closed and protect from humidity. Use appropriate containment measures for pharmaceutical API handling.

Room temperature storage (15-25°C)
Protect from moisture
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Prucalopride exhibits specific serotonin 5-HT4 receptor agonist mechanisms essential for gastrointestinal motility enhancement. Its molecular structure enables selective receptor binding with predictable prokinetic therapeutic responses.

Receptor Binding

Selective 5-HT4 receptor agonist with high affinity binding

Gastrointestinal motility enhancement
Metabolic Pathways

Hepatic metabolism via CYP3A4 and conjugation reactions

Predictable pharmacokinetic profile
Tissue Selectivity

Preferential GI tract 5-HT4 receptor distribution

Targeted therapeutic action
Pharmacological Effects

Enhanced colonic motility and accelerated transit

Constipation relief mechanisms

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international drug development and manufacturing standards.

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical quality

ICH Guidelines

International Conference on Harmonization standards compliance

GMP Certification

Good Manufacturing Practices certified production facility

DMF Support

Drug Master File documentation for regulatory submissions

CEP Available

Certificate of Suitability to European Pharmacopoeia monographs

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.

Formulation Development
  • Dosage form optimization support
  • Stability testing guidance
  • Bioavailability enhancement
  • Custom formulation development
Analytical Services
  • Method development and validation
  • Impurity profiling and identification
  • Stability indicating methods
  • Dissolution testing support
Regulatory Support
  • Regulatory submission assistance
  • DMF preparation and maintenance
  • Pharmacovigilance support
  • Global registration strategy
Supply Solutions
  • Pharmaceutical supply chain management
  • Cold chain logistics
  • Custom packaging solutions
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Sustainable synthetic routes with minimal environmental impact

Water Management

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Packaging

Recyclable pharmaceutical packaging solutions

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent pharmaceutical quality and performance across all production batches.

Production Process

Advanced synthesis and purification in GMP-controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation support.

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance

Reliable Supply

Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Regulatory Assurance

Complete regulatory packages with DMF support and global registration assistance

Global Standards

International compliance with USP, EP, and ICH standards for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services