Rabeprazole Sodium API
Pharmaceutical Premium
Pharmaceutical API

Rabeprazole Sodium

High-purity pharmaceutical grade Rabeprazole Sodium API manufactured to meet stringent USP/EP specifications for proton pump inhibitor and gastric acid suppression 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: C18H20N3NaO3S
CAS Number: 117976-90-6
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white powder
Molecular Weight: 381.43 g/mol
Melting Point: 140-145°C (decomposition)
pH (1% solution): 9.0-10.0
Loss on Drying: ≤1.0%
Residue on Ignition: ≤0.2%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 100g, 500g, 1kg containers

Applications

GERD Treatment
Peptic Ulcer Therapy
Oral Tablet Formulations
Delayed-Release Capsules
H. pylori Eradication
Proton Pump Inhibitor
Acid-Related Disorders
Gastric Acid Suppression
Gastroenterology Research
Clinical Trials
GI Drug Development
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Rabeprazole Sodium grades tailored for specific gastroenterology applications, ensuring optimal proton pump inhibitor activity and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤1.0% 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
Enteric-Coated Grade
Purity: ≥99.5% Stability: Optimized Bioavailability: Enhanced Application: Delayed-release forms

Quality Standards

DRAVYOM's Rabeprazole Sodium 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
PPI Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Cold Chain Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Rabeprazole Sodium exhibits exceptional chemical properties essential for acid suppression applications. Its potent proton pump inhibitor structure and superior stability characteristics ensure reliable performance in demanding gastroesophageal disorder treatment formulations.

Molecular Properties
Molecular Weight: 381.43 g/mol (sodium salt)
Molecular Formula: C18H20N3NaO3S
LogP (Octanol/Water): 1.9
pKa: 4.9
Physical Properties
Melting Point: 130-140°C (decomposes)
Appearance: White to off-white crystalline powder
Solubility (Water): Freely soluble
Bulk Density: 0.50-0.60 g/cm³
Pharmaceutical Properties
Bioavailability: 52%
Protein Binding: 96.3%
Half-life: 1-2 hours
Mechanism: H+/K+-ATPase inhibition
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤0.5%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Rabeprazole Sodium superiority in acid suppression applications with exceptional proton pump inhibition, rapid onset of action, and therapeutic efficacy across diverse gastroesophageal disorder treatment protocols.

Acid Suppression

Superior efficacy in gastric acid reduction

Profound acid suppression
Proton Pump Inhibition

Irreversible H+/K+-ATPase enzyme inhibition

Long-lasting acid suppression
Rapid Onset

Fast-acting acid suppression

Quick symptom relief
GERD Treatment

Effective gastroesophageal reflux disease management

Erosive esophagitis healing
Clinical Efficacy

FDA-approved for acid-related disorders

Proven gastrointestinal benefits
Dosing Convenience

Once-daily dosing for most indications

Patient compliance advantage

Safety Information

Pharmaceutical active ingredient requiring careful handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for acid suppression compounds.

Active Pharmaceutical Ingredient
Controlled Handling Required
Standard PPE Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from moisture and humidity to preserve pharmaceutical quality and acid suppression potency.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Store in dry conditions

Chemical Mechanisms & Reaction Pathways

Rabeprazole Sodium exhibits specific proton pump inhibitor mechanisms through irreversible H+/K+-ATPase enzyme inhibition essential for gastric acid suppression. Its molecular structure enables selective enzyme binding with predictable antisecretory therapeutic responses.

Enzyme Inhibition

Irreversible proton pump (H+/K+-ATPase) inhibition mechanism

Gastric acid secretion suppression
Metabolic Pathways

Hepatic metabolism via CYP2C19 and CYP3A4 enzyme systems

Genetic polymorphism considerations
Gastric Selectivity

Preferential accumulation in gastric parietal cell canaliculi

Targeted antisecretory action
Pharmacological Effects

Profound and sustained gastric acid suppression

Peptic ulcer and GERD treatment

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