Esomeprazole Magnesium Trihydrate API
Pharmaceutical Premium
Pharmaceutical API

Esomeprazole Magnesium Trihydrate

High-purity pharmaceutical grade Esomeprazole Magnesium Trihydrate 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: C34H36MgN6O6S2·3H2O
CAS Number: 217087-09-7
Molecular Weight: 767.17 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Proton Pump Inhibitor Manufacturing
GERD Treatment Formulations
Gastric Acid Suppression Products
API Synthesis & Development
Gastrointestinal Research
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Esomeprazole Magnesium Trihydrate grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse gastric acid suppression and proton pump inhibitor drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Proton pump inhibitor formulations

Quality Standards

DRAVYOM's pharmaceutical grade Esomeprazole Magnesium Trihydrate is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% Pharmaceutical Purity
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Esomeprazole Magnesium Trihydrate exhibits exceptional chemical properties essential for proton pump inhibitor therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Practically insoluble
LogP (octanol/water): 2.3
pKa: 4.0, 9.7
Molecular Weight: 713.12 g/mol
Physical Properties
Appearance: White to off-white crystalline powder
Melting Point: 148-150°C
Bulk Density: 0.4-0.6 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: 64% (oral)
Protein Binding: 97%
Half-life: 1-1.5 hours
Mechanism: Proton pump inhibitor
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: 12.5-13.5% (trihydrate)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable in alkaline conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Esomeprazole Magnesium Trihydrate superiority in proton pump inhibitor applications with exceptional acid suppression, enteric coating compatibility, and reproducibility across diverse therapeutic protocols.

Acid Suppression

Potent proton pump inhibition

Superior acid control
Rapid Onset

Quick therapeutic effect

Fast symptom relief
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 148-150°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Enteric Compatibility

Excellent enteric coating performance

Optimal gastric protection

Safety Information

Prescription pharmaceutical ingredient requiring professional handling. Well-established safety profile for gastric therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for potential drug interactions and long-term use considerations.

Prescription Only
Professional Use
Monitor drug interactions

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate GMP handling techniques for API processing.

Cool storage (15-25°C)
Protect from moisture (hygroscopic)
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Esomeprazole Magnesium Trihydrate exhibits proton pump inhibition properties through selective H+/K+-ATPase enzyme binding in gastric parietal cells, providing sustained acid suppression for gastroesophageal reflux disease and peptic ulcer treatment.

Proton Pump Inhibition

Selective binding to H+/K+-ATPase in gastric parietal cells

Blocks gastric acid secretion
S-Enantiomer Activity

Active S-enantiomer of omeprazole with enhanced stability

Superior acid suppression profile
Sustained Action

Long-lasting acid suppression up to 24 hours

Once-daily dosing convenience
Mucosal Protection

Promotes healing of gastric and duodenal ulcers

Comprehensive gastric protection

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures gastric pharmaceutical manufacturing access with complete documentation packages supporting international standards and proton pump inhibitor development.

USP Standards

United States Pharmacopeia gastric drug specifications

EP Monograph

European Pharmacopoeia specifications for proton pump inhibitors

Gastric GMP

Specialized GMP for gastric drug manufacturing

ICH Guidelines

International gastric drug development regulatory compliance

Gastric DMF

Drug Master File for gastric applications

Safety Documentation

Comprehensive gastric safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's gastric pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Esomeprazole Magnesium Trihydrate gastric applications.

Gastric Formulation
  • Proton pump inhibitor formulation optimization
  • Enteric coating development
  • Bioavailability enhancement
  • Custom gastric development
Analytical Services
  • API purity and potency analysis
  • Gastric impurity profiling
  • Enantiomeric purity testing
  • Method validation support
Regulatory Support
  • Gastric regulatory filing
  • PPI DMF preparation
  • International compliance guidance
  • Gastric pharmacovigilance
Supply Solutions
  • Gastric pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency gastric supply

Environmental Impact & Sustainability

Our Esomeprazole Magnesium Trihydrate production emphasizes environmental responsibility through sustainable pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally friendly synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient pharmaceutical manufacturing processes

Waste Reduction

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of pharmaceutical raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Esomeprazole Magnesium Trihydrate quality and gastric therapeutic performance.

Controlled Production

Advanced manufacturing in controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and gastric analysis
Quality Systems

ISO 9001:2015 quality management with gastric compliance

Continuous improvement and gastric validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive gastric data demonstrating Esomeprazole Magnesium Trihydrate effectiveness in acid suppression therapy with quantified performance metrics and clinical validation data.

Gastric Formulations
Bioavailability: 90% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with enteric coating systems
Therapeutic Applications
GERD: Proven gastroesophageal reflux disease relief Ulcers: Effective peptic ulcer healing Safety: Well-tolerated proton pump inhibitor
Manufacturing Performance
Yield: 96% pharmaceutical grade recovery Purity: >99.5% gastric specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Gastric Excellence

Superior gastric pharmaceutical grade with proven proton pump inhibition and regulatory compliance

Reliable Supply

Guaranteed gastric supply with strategic inventory management and specialized production scheduling

Gastric Expertise

Dedicated gastric pharmaceutical development team with specialized PPI formulation support

Regulatory Compliance

Complete gastric documentation with DMF support and international compliance

Global Standards

International gastric compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative gastric relationships with specialized development services