PEG 4000 - Pharmaceutical Grade Excipient
Industrial Premium
Pharmaceutical Ingredient

Polyethylene Glycol (PEG 4000) Pharma Grade

Premium high-quality pharmaceutical excipient engineered for demanding pharmaceutical applications including tablet formulations, ointment bases, suppository manufacturing, and drug delivery systems. Our pharmaceutical-grade PEG 4000 delivers exceptional solubility enhancement, consistent performance, and reliable biocompatibility for critical pharmaceutical processes requiring superior excipients with stringent regulatory compliance standards.

  • High Pharmaceutical Purity
  • Superior Solubility Enhancement
  • USP/EP/IP Compliant
  • Consistent Performance
  • Tablet Formulations
  • Ointment Applications
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Technical Specifications

Chemical Name: Polyethylene Glycol 4000 (Pharma Grade)
CAS Number: 25322-68-3
Chemical Formula: H(OCH₂CH₂)ₙOH
Average Molecular Weight: 3000-4500 g/mol
Physical State: White waxy solid/flakes
Melting Point: 53-58°C
Loss on Drying: ≤ 0.5%
Residue on Ignition: ≤ 0.1%
Heavy Metals (as Pb): ≤ 5 ppm
pH (5% solution): 4.5-7.5
Hydroxyl Value: 25-35 mg KOH/g
Viscosity (75°C): 40-70 cSt
Microbial Limits: ≤ 100 CFU/g
Shelf Life: 5 years
Packaging Options: 25kg bags, 500kg drums

Applications

Tablet Binder & Lubricant
Capsule Filling Agent
Ointment Base
Suppository Base
Ophthalmic Preparations
Solubilizer & Plasticizer

Industry-Specific Grades

DRAVYOM offers specialized PEG 4000 grades tailored for different pharmaceutical formulation requirements, ensuring optimal performance and regulatory compliance.

Tablet Grade
Binding Properties: Excellent Disintegration: Controlled Flowability: Enhanced Application: Solid dosage forms
Topical Grade
Consistency: Optimized Skin Compatibility: High Stability: Enhanced Application: Ointments & creams
Ophthalmic Grade
Purity: Ultra high Endotoxin: ≤ 0.5 EU/g Osmolality: Controlled Application: Eye preparations
Standard Grade
USP/EP/IP: Compliant Cost Effective: Optimized Versatile: Multi-purpose Application: General formulations

Quality Standards

DRAVYOM's PEG 4000 is manufactured under cGMP conditions, meeting international pharmaceutical standards for excipient applications.

cGMP Certified Manufacturing
Pharmaceutical Grade Standards
3000-4500 g/mol Molecular Weight
USP/EP/IP Compliant
Complete Testing Protocol
Ophthalmic Grade Available
Certificate of Analysis
Pharmaceutical Support

Advanced Chemical Properties & Performance

Pharmaceutical Grade PEG 4000 exhibits exceptional chemical properties essential for pharmaceutical applications. Its polyether structure and precise molecular weight ensure reliable performance in demanding drug formulation and processing applications.

Chemical Properties
Average Molecular Weight: 3000-4500 g/mol
Solubility (Water, 25°C): Freely soluble
Viscosity (50% solution, 25°C): 70-100 cP
Surface Tension: 43-47 mN/m
Physical Properties
Melting Point: 55-60°C
Density (25°C): 1.20-1.25 g/cm³
Flash Point: > 200°C
Refractive Index: 1.467-1.470
Pharmaceutical Performance
PEG Purity: ≥ 99.0% by GC
Water Content: ≤ 0.5% by Karl Fischer
pH (5% solution): 4.5-7.5
Plasticizing Efficiency: Excellent film flexibility
Purity Specifications
Ethylene Oxide: ≤ 1 ppm
Dioxane: ≤ 10 ppm
Heavy Metals: ≤ 10 ppm
Residue on Ignition: ≤ 0.1%
Stability Properties
Shelf Life: 5 years (unopened)
Hygroscopicity: Low moisture uptake
Temperature Stability: Stable up to 200°C
Container Compatibility: HDPE, PP, stainless steel

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade PEG 4000 superiority in drug formulation applications with exceptional solubilization, plasticizing, and processing capabilities across diverse pharmaceutical applications.

Solubilization Performance

Solubility enhancement: 2-10x improvement

Superior drug dissolution
Plasticizing Performance

Film flexibility: 40-60% improvement

Enhanced coating properties
Processing Performance

Melt viscosity: Optimal for processing

Excellent manufacturability
Thermal Stability

Stable up to 200°C

Process stability assured
Batch Reproducibility

Variation: ± 2% molecular weight

Consistent pharmaceutical quality
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical integrity

Safety Information

Generally recognized as safe (GRAS) pharmaceutical excipient. May cause mild eye irritation in molten form. Handle with appropriate protective equipment including heat-resistant gloves and safety goggles when heated. Ensure adequate ventilation in work areas.

GRAS Status
Eye Irritation (Hot)
Hot Melt Hazard

Storage & Handling

Store in original containers in a cool, dry place away from direct sunlight and moisture. Keep containers tightly closed to prevent moisture absorption and contamination. Use pharmaceutical-grade storage equipment and maintain cGMP conditions.

Cool storage (15-25°C)
Protect from moisture
cGMP conditions
Dry, well-ventilated area

Chemical Mechanisms & Reaction Pathways

PEG 4000 exhibits excellent solubilization and plasticizing properties through hydrogen bonding and molecular flexibility, enabling enhanced drug dissolution and pharmaceutical processing with predictable performance characteristics.

Solubilization

Hydrogen bonding interactions for drug solubility enhancement

Essential for poorly soluble drugs
Plasticization

Polymer chain mobility for film coating and tablet applications

Critical for controlled release systems
Wetting Properties

Surface tension reduction for improved drug wetting and dissolution

Enables rapid drug release
Molecular Weight

Optimal molecular weight for pharmaceutical processing and performance

Important for formulation optimization

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures pharmaceutical-grade PEG 4000 meets international pharmacopeial standards with complete documentation packages supporting drug development and regulatory submissions.

Pharmacopeial Standards

USP, EP, and JP compliance for pharmaceutical excipient applications

GMP Compliance

Good Manufacturing Practice protocols for pharmaceutical excipients

Safety Documentation

Complete toxicological data and pharmaceutical safety profiles

International Registration

DMF filings and excipient master file documentation

Quality Documentation

Certificates of analysis and pharmaceutical quality certificates

Supply Chain

GMP-compliant transportation and pharmaceutical logistics

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical excipient support team provides comprehensive formulation guidance, technical assistance, and regulatory support to optimize PEG 4000 applications in pharmaceutical manufacturing.

Formulation Support
  • Solubility enhancement strategies
  • Solid dispersion optimization
  • Coating formulation development
  • Suppository base formulation
Technical Services
  • Molecular weight verification
  • Dissolution testing support
  • Stability testing guidance
  • Process optimization assistance
Regulatory Services
  • DMF preparation assistance
  • Regulatory submission support
  • Quality system documentation
  • Pharmacopeial compliance verification
Supply Solutions
  • Pharmaceutical-grade packaging
  • Just-in-time delivery programs
  • Custom molecular weight grades
  • Inventory management services

Environmental Impact & Sustainability

Our pharmaceutical PEG 4000 production emphasizes environmental responsibility through sustainable sourcing, energy-efficient manufacturing, and comprehensive environmental impact management for sustainable pharmaceutical development.

Sustainable Sourcing

Renewable ethylene oxide sources with sustainable chemical practices

Green Chemistry

Environmentally friendly polymerization processes

Clean Production

Energy-efficient manufacturing with emission controls

Waste Management

Pharmaceutical waste minimization and recycling programs

Environmental Standards

ISO 14001 environmental management system compliance

Packaging Solutions

Recyclable pharmaceutical packaging and container programs

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical PEG 4000 manufacturing facility employs advanced polymerization technology and quality systems to ensure consistent pharmaceutical-grade quality and performance across all production batches.

Advanced Polymerization

Controlled polymerization processes for consistent molecular weight distribution

Optimal molecular weight and purity control
Quality Testing

Comprehensive testing including molecular weight, viscosity, and pharmaceutical properties

USP/EP method validation and compliance
GMP Systems

cGMP compliance with pharmaceutical excipient quality systems

FDA and EMA inspection-ready facilities
Pharmaceutical Packaging

Moisture-controlled packaging with pharmaceutical-grade containers

Stability-optimized packaging systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating PEG 4000 effectiveness across drug formulation applications with validated performance metrics and pharmaceutical industry adoption for solubility enhancement.

Solid Dispersions
Solubility Enhancement: 500% improvement in drug dissolution Performance: Consistent bioavailability improvement Customer Satisfaction: 97% pharmaceutical approval
Coating Applications
Film Quality: Superior plasticizing properties Process Efficiency: 25% coating time reduction Market Penetration: 45% enteric coating segment
Suppository Bases
Base Quality: Excellent melting characteristics Drug Release: Predictable release profiles Cost Effectiveness: 30% formulation cost savings

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

cGMP-compliant PEG manufacturing with pharmaceutical regulatory expertise and formulation support

Polymer Innovation

Advanced polymerization technology with custom molecular weight grades and purity optimization

Quality Assurance

Comprehensive quality control with pharmaceutical-grade documentation and batch traceability

Reliable Supply

Consistent pharmaceutical supply chain with just-in-time delivery and inventory management

Regulatory Support

DMF filing assistance with regulatory submission support and global compliance expertise

Partnership Approach

Long-term pharmaceutical partnerships with formulation development and technical collaboration