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 material exhibits reliable properties suitable for pharmaceutical formulations and quality manufacturing. Its consistent composition ensures predictable performance in drug development and production environments.

Basic Properties
Pharmaceutical Grade: USP/EP compliant material
Functionality: Excipient performance properties
Compatibility: Compatible with active ingredients
Stability: Stable under pharmaceutical conditions
Physical Properties
Physical Form: Powder or granular material
Particle Size: Controlled particle distribution
Bulk Density: Optimized for processing
Flow Properties: Good flow characteristics
Pharmaceutical Performance
Formulation Suitability: Excellent for drug formulations
Processing: Suitable for various processes
Dissolution: Predictable dissolution behavior
Bioavailability: Does not affect drug bioavailability
Quality Standards
Purity: ≥99.0% pharmaceutical grade
Heavy Metals: ≤10 ppm
Microbial Limits: USP/EP compliant
Residual Solvents: Within ICH Q3C limits
Stability Properties
Shelf Life: 5 years (unopened)
Storage Stability: Stable under controlled conditions
Retest Period: As per pharmacopeial standards
Container Closure: Pharmaceutical grade packaging

Performance Characteristics

Performance metrics demonstrate pharmaceutical grade reliability in drug formulation and manufacturing applications with consistent quality, regulatory compliance, and optimal performance for pharmaceutical processes.

Formulation Performance

Efficiency: Consistent excipient functionality

Excellent for drug formulations
Regulatory Compliance

Standards: USP/EP/BP pharmacopeial compliance

Meets regulatory requirements
Manufacturing Use

Reliability: Consistent performance in production

Suitable for pharmaceutical manufacturing
Quality Assurance

Validation: Comprehensive quality testing

Validated pharmaceutical material
Batch Consistency

Variation: ±1% between batches

Superior batch-to-batch consistency
Shelf Life

Duration: 5 years under proper storage

Extended stability for pharmaceutical use

Safety Information

Generally safe for pharmaceutical use when handled according to Good Manufacturing Practices. Use appropriate protective equipment including gloves and safety goggles during handling. Follow pharmaceutical handling protocols and maintain clean room standards where applicable.

Pharmaceutical Safe
GMP Handling
Regulatory Approved

Storage & Handling

Store in original pharmaceutical packaging in a controlled environment as per ICH guidelines. Maintain appropriate temperature and humidity conditions. Use pharmaceutical storage equipment and follow Good Distribution Practices for inventory management.

Store at 15-30°C
Relative humidity ≤60%
Original pharmaceutical packaging
GMP storage conditions

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