Omeprazole Magnesium API
Pharmaceutical Premium
Pharmaceutical API

Omeprazole Magnesium

High-purity pharmaceutical grade Omeprazole Magnesium 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
CAS Number: 95382-33-5
Molecular Weight: 713.12 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
pH (1% suspension): 9.0-11.0
Loss on Drying: ≤1.0%
Residue on Ignition: ≤0.2%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Magnesium Content: 3.2-3.6% (w/w)
Solubility: Practically insoluble in water
Storage Conditions: Store at room temperature, protect from moisture
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Oral Tablet Formulations
Capsule Formulations
GERD Treatment
Peptic Ulcer Management
Proton Pump Inhibitor
Acid Suppression Therapy
Gastric Acid Reduction
Gastroenterology
Pharmaceutical Research
Clinical Applications
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Omeprazole Magnesium grades tailored for specific gastroenterology pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse acid suppression therapy 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) pH: 9.0-11.0 (1% suspension) Magnesium Content: 3.2-3.6% Application: EU regulatory submissions
Gastroenterology Grade
Purity: ≥99.5% (HPLC) Acid Stability: Enhanced Dissolution: Optimized Application: Specialized formulations
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Pharmaceutical Testing
Gastroenterology Grade
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Omeprazole Magnesium exhibits exceptional proton pump inhibitor properties essential for gastroenterology applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding acid suppression formulations.

Molecular Properties
Molecular Weight: 713.12 g/mol
LogP: 2.23
pKa: 4.0, 8.8
Bioavailability: 65%
Physical Properties
Melting Point: 156°C
Solubility (Water): 0.4 mg/mL
Crystalline Form: Stable polymorph
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
H+/K+-ATPase IC50: 6.6 μM
Acid Suppression: 99% at 24h
Selectivity: Proton pump specific
Stability: Stable in solid state
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable at room temperature
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Omeprazole Magnesium superiority in gastroenterology applications with exceptional acid suppression, bioavailability, and reproducibility across diverse PPI formulations.

Acid Suppression

99% suppression at 24 hours

Complete gastric acid control
Bioavailability

Oral: 65% absolute bioavailability

Excellent drug absorption
Stability

Solid state: >5 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade proton pump inhibitor requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for PPI 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 light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.

Cool storage (2-8°C)
Protect from light
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Omeprazole magnesium functions as a proton pump inhibitor through irreversible H+/K+-ATPase blockade, providing sustained gastric acid suppression with enhanced bioavailability from the magnesium salt formulation.

Proton Pump Inhibition

Irreversible binding to H+/K+-ATPase enzyme

Complete gastric acid suppression
Acid Activation

Acid-catalyzed conversion to active sulfenamide

Targeted activation in acidic environment
Magnesium Enhancement

Improved solubility and bioavailability

Enhanced therapeutic performance
Long Duration

Sustained acid suppression for 24+ hours

Once-daily dosing convenience

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Omeprazole Magnesium performance in pharmaceutical applications.

Formulation Development
  • Delayed-release capsule formulations
  • Enteric-coated tablet development
  • Stability enhancement strategies
  • Combination drug development
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Dissolution testing support
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Flexible packaging options
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

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

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

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

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, LC-MS, and pharmacopeial methods
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with moisture protection

Stability maintenance and protection systems

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Bioavailability: Enhanced by magnesium salt Stability: 3+ years shelf life Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Gastric acid suppressants Regulatory Success: Global approvals achieved Innovation: Delayed-release technologies
Clinical Applications
Efficacy: Superior acid suppression Safety: Well-established safety profile Convenience: Once-daily dosing

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services