Itopride HCl API
Pharmaceutical Premium
Pharmaceutical API

Itopride HCl

High-purity pharmaceutical grade Itopride HCl API manufactured to meet stringent USP/EP specifications for gastroprokinetic and gastric motility formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical drug manufacturing applications.

  • USP/EP Grade Quality Standards
  • High Purity ≥99.0% (HPLC)
  • Comprehensive Analytical Documentation
  • Regulatory Compliance Support
  • cGMP Manufacturing Standards
  • Pharmaceutical Grade Packaging
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Technical Specifications

Chemical Formula: C20H26N2O4·HCl
CAS Number: 122892-31-3
EINECS Number: Not Available
Molecular Weight: 394.89 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 170-175°C
pH (1% solution): 4.0-6.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Oral Tablet Formulations
Capsule Formulations
Gastroprokinetic Therapy
Gastric Motility Disorders
Dopamine Receptor Research
Hospital Gastroenterology Units
Pharmaceutical Manufacturing
Gastrointestinal Drugs
Motility Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Itopride HCl grades tailored for specific gastroprokinetic pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse gastrointestinal drug manufacturing applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Impurities: Individual ≤0.5% Loss on Drying: ≤0.5% Application: EU regulatory submissions
Gastroenterology Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Motility research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Itopride HCl API is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP, and cGMP specifications. Our pharmaceutical-grade production ensures consistent performance and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Ultra-Low Impurity Levels
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical Grade Itopride HCl exhibits exceptional chemical properties essential for gastrointestinal therapeutic applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and clinical applications.

Molecular Properties
Molecular Weight: 379.85 g/mol
Melting Point: 194-196°C
Solubility (Water): Freely soluble
LogP (Octanol/Water): 2.1
Physical Properties
Appearance: White crystalline powder
Bulk Density: 0.45-0.65 g/cm³
Particle Size: D90 ≤ 100 μm
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Properties
Bioavailability: 60-75% (oral)
Half-life: 6-8 hours
Protein Binding: 95-98%
Dissolution Rate: 85% in 30 min
Purity Specifications
Assay (HPLC): 99.0-101.0%
Related Substances: ≤1.0% total
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-30°C
Light Sensitivity: Protect from light
Moisture Sensitivity: Store in dry place

Performance Characteristics

Detailed performance metrics demonstrate Itopride HCl superiority in gastrointestinal therapeutic applications with exceptional bioavailability, pharmacokinetics, and clinical efficacy across diverse patient populations and treatment protocols.

Bioavailability

Oral absorption: 60-75% bioavailability

Excellent gastrointestinal absorption
Pharmacokinetics

Peak plasma: 1-2 hours post-dose

Rapid onset of action
Dissolution Profile

85% dissolved in 30 minutes

Fast-acting formulation capability
Stability Performance

Stable across 15-30°C range

Robust storage conditions
Batch Consistency

≤2% variation between batches

Excellent manufacturing reproducibility
Formulation Flexibility

Compatible with various excipients

Versatile pharmaceutical applications

Safety Information

Handle with appropriate pharmaceutical safety protocols. Use personal protective equipment including safety glasses, gloves, and lab coats. Ensure adequate ventilation and avoid dust generation. Store away from incompatible materials and follow standard pharmaceutical handling procedures.

Caution Required
Avoid Inhalation
Wear Gloves

Storage & Handling

Store in original pharmaceutical-grade containers in a cool, dry, well-ventilated area. Keep containers tightly closed and protect from direct sunlight and moisture. Use appropriate pharmaceutical storage equipment and ensure proper environmental controls for optimal product stability.

Store at 15-30°C
Protect from moisture
Original container storage
Protect from light

Chemical Mechanisms & Reaction Pathways

Itopride HCl exhibits dual prokinetic activity through specific dopamine D2 receptor antagonism and acetylcholinesterase inhibition, enabling precise gastrointestinal applications with predictable pharmacokinetic pathways and quantitative motility enhancement.

D2 Receptor Antagonism

Selective binding to dopamine D2 receptors enhancing gastric motility

Therapeutic mechanism for gastroparesis treatment
Acetylcholinesterase Inhibition

Increased acetylcholine levels promoting gastrointestinal contractions

Essential for prokinetic activity
Gastric Emptying

Enhanced gastric and duodenal motility coordination

Enables selective therapeutic applications
Antiemetic Effect

Central and peripheral antiemetic activity through dual mechanisms

Controlled therapeutic environment for GI treatment

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international standards and therapeutic method validations.

USP Grade Specifications

United States Pharmacopeia pharmaceutical grade standards compliance

EP Monograph Standard

European Pharmacopoeia standard for pharmaceutical specifications

IP Grade Available

Indian Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonisation pharmaceutical compliance

Method Validation

Supported pharmaceutical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing, and regulatory services to optimize Itopride HCl performance in your specific pharmaceutical applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence studies
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • cGMP best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our Itopride HCl production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with cGMP compliance

Continuous improvement and method validation
Packaging Control

Pharmaceutical grade containers with controlled atmosphere packaging

Light protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Itopride HCl effectiveness across diverse gastrointestinal applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: >85% in formulations Stability: 3 years shelf life
Research Institutions
Publications: 500+ cited studies Clinical Trials: 30+ ongoing studies Innovation: GI motility research
Contract Manufacturing
Reliability: 99.9% batch consistency Compliance: 100% regulatory approval Efficiency: 25% cost reduction

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmacopeia specifications with ultra-low impurities and exceptional pharmaceutical performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and stability studies

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services