Pantoprazole Sodium API
Pharmaceutical Premium
Pharmaceutical API

Pantoprazole Sodium

High-purity pharmaceutical grade Pantoprazole 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: C16H14F2N3NaO4S
CAS Number: 138786-67-1
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 405.37 g/mol
Melting Point: Decomposes at >150°C
pH (1% solution): 9.0-10.5
Loss on Drying: ≤1.5%
Residue on Ignition: ≤0.2%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water
Storage Conditions: Store below 25°C, dry place
Shelf Life: 3 years from manufacture date
Packaging Options: 25kg, 50kg fiber drums

Applications

Gastric Acid Suppression
GERD Treatment
Enteric-Coated Tablets
Proton Pump Inhibitor
Injectable Formulations
Peptic Ulcer Treatment
Acid-Related Disorders
Helicobacter Pylori Eradication
Gastroenterology Research
Drug Development
Pharmaceutical Studies
Clinical Trials

Industry-Specific Grades

DRAVYOM offers specialized Pantoprazole Sodium grades tailored for specific gastroenterology applications, ensuring optimal proton pump inhibition efficacy and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤1.5% 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
Injectable Grade
Purity: ≥99.5% Sterility: Assured Endotoxins: <0.25 EU/mg Application: IV proton pump inhibition
Enteric Grade
Purity: ≥99.0% Stability: Acid-resistant Particle Size: Optimized Application: Enteric-coated formulations

Quality Standards

DRAVYOM's Pantoprazole Sodium is manufactured under stringent cGMP protocols, meeting international gastroenterology drug standards including USP, EP, and FDA guidelines for proton pump inhibitor applications.

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

Advanced Chemical Properties & Performance

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

Molecular Properties
Molecular Weight: 405.36 g/mol
LogP: 2.2
pKa: 3.9, 8.1
Bioavailability: 77%
Physical Properties
Melting Point: 138-142°C
Solubility (Water): 70 mg/mL
Crystalline Form: Stable sodium salt
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
H+/K+-ATPase IC50: 6.8 μM
Acid Suppression: Potent
Selectivity: PPI selective
Stability: Acid-labile prodrug
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: Protect from light
Temperature Stability: Room temperature stable
pH Stability: Unstable in acidic pH

Performance Characteristics

Detailed performance metrics demonstrate Pantoprazole Sodium superiority in gastroenterological applications with exceptional proton pump inhibition, bioavailability, and reproducibility across diverse acid suppression formulations.

PPI Activity

IC50: 6.8 μM H+/K+-ATPase

Potent acid suppression
Bioavailability

Oral: 77% bioavailability

High systemic exposure
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 gastroenterological 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 light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.

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

Chemical Mechanisms & Reaction Pathways

Pantoprazole sodium functions as a proton pump inhibitor through irreversible inhibition of H+/K+-ATPase enzyme, providing effective gastric acid suppression with improved stability and bioavailability compared to other proton pump inhibitors.

Proton Pump Inhibition

Irreversible inhibition of gastric H+/K+-ATPase

Complete gastric acid suppression
Acid Activation

Acid-activated conversion to active sulfenamide

Site-specific enzyme binding
Stability Profile

Enhanced stability in alkaline conditions

Improved therapeutic reliability
Pharmacokinetic Profile

Excellent oral bioavailability with dose-proportional kinetics

Predictable therapeutic response

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 Pantoprazole sodium performance in pharmaceutical applications.

Formulation Development
  • Enteric-coated tablet development
  • Injectable formulation optimization
  • Delayed-release formulations
  • Stability enhancement strategies
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Proton pump inhibitor analysis
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Controlled storage packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Pantoprazole sodium 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 Pantoprazole sodium 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 proton pump assays
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 Pantoprazole sodium effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Bioavailability: >75% oral absorption Stability: 3+ years shelf life Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Gastroenterology products Regulatory Success: Global approvals achieved Innovation: Delayed-release systems
Clinical Applications
Efficacy: Superior acid suppression Safety: Excellent tolerance profile Versatility: GERD and PUD treatment

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