Ibuprofen - API Grade Anti-inflammatory Ingredient
Industrial Premium
Pharmaceutical Ingredient

Ibuprofen (API Grade)

Premium high-purity active pharmaceutical ingredient engineered for demanding pharmaceutical applications including anti-inflammatory medications, pain relief formulations, NSAID products, and over-the-counter drug manufacturing. Our API-grade ibuprofen delivers exceptional purity, consistent performance, and reliable therapeutic efficacy for critical pharmaceutical processes requiring superior active ingredients with stringent regulatory compliance standards.

  • High API Purity
  • Superior Anti-inflammatory
  • USP/EP/IP Compliant
  • Consistent Performance
  • NSAID Formulations
  • Regulatory Compliance
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Technical Specifications

Chemical Name: Ibuprofen (API Grade)
CAS Number: 15687-27-1
Chemical Formula: C₁₃H₁₈O₂
Purity (Assay): ≥ 98.5% (API Grade)
Physical State: White crystalline powder
Molecular Weight: 206.28 g/mol
Melting Point: 75-78°C
Loss on Drying: ≤ 0.5%
Residue on Ignition: ≤ 0.1%
Heavy Metals (as Pb): ≤ 20 ppm
Related Substances: ≤ 0.5% (Total impurities)
Chloride: ≤ 200 ppm
Microbial Limits: ≤ 100 CFU/g
Shelf Life: 3 years
Packaging Options: 25kg fiber drums

Applications

Pain Relief Tablets
Anti-inflammatory Capsules
Liquid Formulations
Pediatric Suspensions
Topical Gels
Fever Reducers

Industry-Specific Grades

DRAVYOM offers specialized ibuprofen grades tailored for different pharmaceutical formulation requirements, ensuring optimal performance and regulatory compliance.

API Grade
Purity: ≥ 98.5% USP/EP/IP: Compliant cGMP: Manufactured Application: Drug formulation
Pediatric Grade
Ultra Pure: ≥ 99.0% Low Impurities: Enhanced Taste Masked: Available Application: Children formulations
Topical Grade
Micronized: Available Particle Size: Controlled Solubility: Enhanced Application: Topical preparations
Generic Grade
Cost Effective: Optimized Quality: Assured Regulatory: Filed Application: Generic drugs

Quality Standards

DRAVYOM's Ibuprofen API is manufactured under cGMP conditions, meeting international pharmaceutical standards for pain relief and anti-inflammatory applications.

cGMP Certified Manufacturing
API Grade Standards
≥ 98.5% Active Ingredient
USP/EP/IP Compliant
Complete Impurity Profiling
Anti-inflammatory Testing
Regulatory Documentation
Pain Relief Efficacy

Advanced Chemical Properties & Performance

API Grade Ibuprofen exhibits excellent anti-inflammatory properties with superior bioavailability and stability characteristics for pharmaceutical formulations. Its validated performance ensures reliable therapeutic efficacy and regulatory compliance for commercial drug manufacturing.

Pharmacological Properties
COX Selectivity: Non-selective COX inhibitor
Anti-inflammatory: Potent NSAID activity
Analgesic Potency: Effective pain relief
Bioavailability: 80-90% oral absorption
Physical Properties
Melting Point: 75-77°C
Appearance: White to off-white crystalline powder
Solubility: Practically insoluble in water
LogP: 3.97 (lipophilic)
Pharmaceutical Performance
Tablet Formulation: Direct compression compatible
Capsule Filling: Suitable for encapsulation
Suspension: Liquid formulation compatible
Stability: Stable under normal conditions
Composition Standards
Assay: 99.0-101.0%
Related Substances: ≤0.1% any individual
Heavy Metals: ≤10 ppm
Residual Solvents: Within ICH limits
Stability Properties
Shelf Life: 36 months (unopened)
Photostability: Stable to light exposure
Thermal Stability: Stable below 25°C
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Performance metrics demonstrate API Grade Ibuprofen reliability in pharmaceutical manufacturing with consistent quality, superior therapeutic efficacy, and regulatory compliance for commercial drug production.

API Quality

Assay: 99.0-101.0% active ingredient

Pharmaceutical grade purity
Therapeutic Efficacy

Bioavailability: 80-90% absorption

Reliable therapeutic response
Regulatory Compliance

Standards: USP/EP/IP compliance

Global regulatory acceptance
Manufacturing Economics

Yield: High production efficiency

Cost-effective API source
Quality Consistency

Variation: ±0.5% batch performance

Reliable production results
Stability Performance

Duration: 36 months shelf life

Extended product stability

Safety Information

Active pharmaceutical ingredient requiring controlled handling in cGMP environments. Follow pharmaceutical manufacturing protocols with appropriate protective equipment, dust control measures, and regulatory documentation. Maintain strict quality control and traceability for drug manufacturing compliance.

Active Pharmaceutical Ingredient
cGMP Required
Quality Control

Storage & Handling

Store in original pharmaceutical-grade containers in controlled temperature and humidity conditions. Maintain storage at room temperature in dry conditions and follow pharmaceutical storage protocols. Use validated storage equipment and maintain complete documentation for regulatory compliance.

Store below 25°C
Keep dry, protect from moisture
Complete documentation required
Pharmaceutical protocols

Chemical Mechanisms & Reaction Pathways

Ibuprofen demonstrates controlled pharmaceutical mechanisms through optimized molecular interactions, enabling predictable therapeutic effects with well-characterized pharmacokinetic and pharmacodynamic properties for reliable pharmaceutical applications.

COX Inhibition

Selective cyclooxygenase inhibition for anti-inflammatory action

Primary therapeutic mechanism
Molecular Binding

Specific protein binding with predictable pharmacokinetics

Controlled drug distribution
Metabolic Pathways

Well-characterized hepatic metabolism and elimination

Predictable drug clearance
Kinetic Profile

Optimized absorption and bioavailability characteristics

Reliable therapeutic response

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures pharmaceutical manufacturing standards with complete documentation packages supporting FDA, EMA, and global regulatory requirements for API production and pharmaceutical applications.

API Standards

USP, EP, and JP pharmacopeial compliance

cGMP Manufacturing

Current Good Manufacturing Practice compliance

Quality Systems

ICH Q7 guidelines and pharmaceutical QMS

Global Registration

Drug Master File and regulatory submissions

Documentation

Complete analytical data and stability studies

Testing Protocols

Validated analytical methods and specifications

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical support team provides comprehensive guidance, regulatory assistance, and technical expertise to optimize API use in pharmaceutical manufacturing and drug development applications.

Pharmaceutical Support
  • Formulation development assistance
  • API optimization and characterization
  • Stability testing guidance
  • Regulatory documentation support
Manufacturing Services
  • Scale-up process optimization
  • Quality control method transfer
  • cGMP compliance consultation
  • Supply chain management
Regulatory Services
  • Drug Master File preparation
  • Regulatory submission support
  • Global compliance guidance
  • Audit preparation and support
Supply Solutions
  • Custom packaging and labeling
  • Just-in-time delivery programs
  • Temperature-controlled logistics
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical API production emphasizes environmental responsibility through green chemistry principles, waste minimization, and comprehensive environmental impact management for sustainable pharmaceutical manufacturing.

Green Manufacturing

Optimized synthesis with reduced waste generation

Solvent Recovery

Advanced solvent recycling and recovery systems

Clean Production

Energy-efficient processes with emission controls

Water Management

Water treatment and recycling programs

Environmental Standards

ISO 14001 environmental management compliance

Sustainability Programs

Carbon footprint reduction and sustainability goals

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical manufacturing facility employs advanced production technology and quality monitoring systems to ensure consistent API quality and performance across all production batches for pharmaceutical applications.

cGMP Production

State-of-the-art pharmaceutical manufacturing with controlled conditions

Highest quality standards for API production
Quality Testing

Comprehensive testing including identity, purity, and potency

Complete analytical characterization
Quality Systems

ICH Q7 guidelines with pharmaceutical quality management

Regulatory compliant manufacturing processes
Packaging Standards

Pharmaceutical-grade packaging with complete documentation

Secure packaging for API distribution

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating API effectiveness across formulation applications with validated performance metrics and regulatory approval validation.

Pharmaceutical Manufacturing
Quality Record: 99.9% batch release rate Performance: Consistent therapeutic efficacy Regulatory: Global approval support
Generic Drug Production
Bioequivalence: Proven BE study support Cost Efficiency: 30% manufacturing savings Supply Reliability: 99.8% on-time delivery
Formulation Development
Compatibility: Wide excipient compatibility Stability: 36-month shelf life validation Development Support: 95% project success rate

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

cGMP manufacturing with global regulatory compliance and pharmaceutical-grade quality standards

Regulatory Expertise

Comprehensive regulatory support with Drug Master Files and global submission assistance

Quality Assurance

Advanced quality systems with complete batch documentation and analytical support

Reliable Supply

Consistent API availability with pharmaceutical distribution networks and supply chain management

Technical Support

Expert pharmaceutical guidance with formulation development and regulatory compliance assistance

Partnership Approach

Long-term pharmaceutical partnerships with comprehensive technical and regulatory support services