Lansoprazole API
Pharmaceutical Premium
Pharmaceutical API

Lansoprazole

High-purity pharmaceutical grade Lansoprazole 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: C16H14F3N3O2S
CAS Number: 103577-45-3
EINECS Number: Not Available
Molecular Weight: 369.36 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 166-170°C
pH (1% solution): 9.0-10.5
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
Delayed-Release Capsules
Gastric Acid Suppression
GERD Treatment
PPI Research
Hospital Gastroenterology
Pharmaceutical Manufacturing
Ulcer Treatment
Gastric Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Lansoprazole grades tailored for specific gastric acid suppression pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse proton pump inhibitor 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: PPI research
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Lansoprazole 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 Lansoprazole exhibits exceptional chemical properties essential for proton pump inhibitor therapeutic applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and clinical applications.

Molecular Properties
Molecular Weight: 369.36 g/mol
Melting Point: 166-169°C
Solubility (Water): Slightly soluble
LogP (Octanol/Water): 2.28
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: 80-85% (oral)
Half-life: 1-1.5 hours
Protein Binding: 97%
Dissolution Rate: pH dependent
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 Lansoprazole superiority in proton pump inhibitor therapeutic applications with exceptional bioavailability, pharmacokinetics, and clinical efficacy across diverse patient populations and treatment protocols.

Bioavailability

Oral absorption: 80-85% bioavailability

Good gastrointestinal absorption
Pharmacokinetics

Peak plasma: 1.7 hours post-dose

Rapid absorption profile
PPI Activity

Proton pump inhibition verified

Effective acid suppression
Stability Performance

Stable across 15-30°C range

Robust storage conditions
Batch Consistency

≤2% variation between batches

Excellent manufacturing reproducibility
Formulation Flexibility

Compatible with enteric coating systems

Acid-resistant formulations

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

Lansoprazole exhibits potent acid suppression through irreversible proton pump inhibition, enabling precise gastric acid control applications with predictable pharmacokinetic pathways and quantitative H+/K+-ATPase enzyme inactivation.

Proton Pump Inhibition

Irreversible binding to gastric H+/K+-ATPase enzyme

Therapeutic mechanism for acid suppression
Acid-Activated

Conversion to active sulfenamide in acidic environment

Essential for selective gastric activity
Covalent Binding

Formation of disulfide bonds with cysteine residues

Enables selective therapeutic applications
Gastric Selectivity

Specific accumulation in gastric parietal cells

Controlled therapeutic environment for acid-related disorders

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 Lansoprazole 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 Lansoprazole 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 Lansoprazole 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 Lansoprazole effectiveness across diverse acid-related disorder applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: >80% in formulations Stability: 3 years shelf life
Research Institutions
Publications: 1500+ cited studies Clinical Trials: 80+ ongoing studies Innovation: Gastrointestinal therapy development
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