Polysorbate 80
Pharmaceutical Premium
Pharmaceutical Excipient

Polysorbate 80

High-purity pharmaceutical Polysorbate 80 manufactured to meet stringent USP and EP specifications for emulsifying applications. Our Polysorbate 80 provides excellent emulsifying properties with superior solubilizing capabilities for various pharmaceutical formulations.

  • USP/EP Pharmaceutical Grade
  • Superior Emulsifying Properties
  • Excellent Solubilizing Properties
  • Enhanced Stability
  • Consistent Quality
  • Ultra-Low Impurities
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Technical Specifications

Chemical Formula: C64H124O26
CAS Number: 9005-65-6
EINECS Number: 232-689-0
Grade: USP/EP Pharmaceutical Grade
Physical State: Amber-colored viscous liquid
Molecular Weight: ~1310 g/mol (average)
HLB Value: 15.0 ± 1.0
Acid Value: ≤2.0 mg KOH/g
Saponification Value: 45-55 mg KOH/g
Iodine Value: 18-24
Heavy Metals: ≤10 ppm
Water Content: ≤3.0%
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1kg, 5kg, 25kg containers

Applications

Emulsifying Agent
Solubilizing Agent
Injectable Formulations
Tablet Preparations
Vaccine Formulations
Capsule Preparations
Ophthalmic Solutions
Topical Formulations
Stabilizer Applications
Dispersing Agent
Wetting Agent
Pharmaceutical Research

Industry-Specific Grades

DRAVYOM offers specialized Polysorbate 80 grades tailored for specific pharmaceutical applications, ensuring optimal emulsifying efficacy and regulatory compliance across diverse formulation requirements.

USP Grade (United States Pharmacopoeia)
HLB Value: 15.0 ± 1.0 Water Content: ≤3.0% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Acid Value: ≤2.0 mg KOH/g Saponification Value: 45-55 Iodine Value: 18-24 Application: European market compliance
Injectable Grade
Sterility: Assured Endotoxins: <0.25 EU/mg Particulates: Controlled Application: Parenteral preparations
High Performance Grade
Enhanced Purity: >99.0% Low Peroxide Value: <5.0 Superior Emulsification: Verified Application: Critical formulations

Quality Standards

DRAVYOM's Polysorbate 80 is manufactured under stringent cGMP protocols, meeting international pharmaceutical excipient standards including USP, EP, and FDA guidelines for emulsifying applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
HLB Value 15.0 ± 1.0
Advanced Analytical Testing
Emulsifying Efficacy Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Polysorbate 80 exhibits exceptional chemical properties essential for pharmaceutical applications. Its superior emulsification capabilities and stability characteristics ensure reliable performance in demanding pharmaceutical formulation systems.

Molecular Properties
Molecular Weight: ~1310 g/mol (average)
Chemical Structure: Polyoxyethylene sorbitan monooleate
HLB Value: 15.0
Ethylene Oxide Units: ~20 units
Physical Properties
Appearance: Amber-colored viscous liquid
Viscosity (25°C): 300-500 cP
Specific Gravity: 1.06-1.09
Solubility (Water): Freely soluble
Pharmaceutical Properties
CMC (Critical Micelle Concentration): 0.012 mM
Surface Tension Reduction: 37-40 mN/m
pH Stability: 4.0-8.0
Emulsification Type: Oil-in-water (O/W)
Quality Specifications
Purity: ≥98.0%
Water Content: ≤3.0%
Acid Value: ≤2.0 mg KOH/g
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Oxidation Resistance: Antioxidant stabilized

Performance Characteristics

Detailed performance metrics demonstrate Polysorbate 80 superiority in pharmaceutical applications with exceptional emulsification, solubilization, and stabilization across diverse formulation systems.

Emulsification Power

Superior oil-in-water emulsion formation

Stable pharmaceutical emulsions
Solubilization

Enhanced drug solubility and bioavailability

Improved dissolution rates
Protein Stabilization

Protection against protein aggregation

Biotech formulation stability
Injectable Compatibility

Safe for parenteral formulations

IV/IM administration approved
Regulatory Compliance

USP/EP/FDA approved excipient

Global regulatory acceptance
Wetting Agent

Excellent surface tension reduction

Enhanced formulation properties

Safety Information

Generally recognized as safe (GRAS) pharmaceutical excipient requiring standard handling protocols. Handle in controlled environments with appropriate ventilation systems. Use proper personal protective equipment and follow established safety protocols for surfactant materials.

GRAS Status
Standard PPE Required
Good Manufacturing Practices

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from oxidation to preserve emulsification properties and pharmaceutical quality.

Controlled room temperature (15-25°C)
Protect from light
Light-resistant containers
Antioxidant protection

Chemical Mechanisms & Reaction Pathways

Polysorbate 80 functions as a non-ionic surfactant with excellent solubilization and emulsification properties, providing stable pharmaceutical formulations through hydrophilic-lipophilic balance and enhanced drug bioavailability.

Surfactant Action

Non-ionic emulsification with optimal HLB value

Stabilizes oil-in-water emulsions
Solubilization

Enhanced solubility of poorly water-soluble drugs

Improved bioavailability profiles
Stability Enhancement

Prevents aggregation and precipitation of proteins

Maintains formulation integrity
Compatibility Profile

Compatible with various pharmaceutical excipients

Versatile formulation applications

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 Polysorbate 80 performance in pharmaceutical applications.

Formulation Development
  • Emulsion system optimization
  • Protein stabilization strategies
  • Injectable formulation development
  • Solubility enhancement studies
Analytical Services
  • Method validation and transfer
  • Peroxide value testing
  • Stability testing programs
  • Surfactant activity assays
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Nitrogen-protected packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Polysorbate 80 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 Polysorbate 80 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 purity and surfactant properties

GC, HPLC, and peroxide value analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Nitrogen-protected packaging with anti-oxidant measures

Oxidation prevention and quality maintenance

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Polysorbate 80 effectiveness across diverse therapeutic applications with quantified performance metrics and regulatory validation.

Pharmaceutical Manufacturing
HLB Value: 15.0 (oil-in-water emulsifier) Stability: 3+ years pharmaceutical grade Purity: >99% pharmaceutical grade
Drug Development
Formulation Support: Injectable and oral products Regulatory Success: Global approvals achieved Innovation: Protein stabilization formulations
Clinical Applications
Safety: GRAS status and pharmaceutical acceptance Efficacy: Enhanced drug solubilization Versatility: Multiple dosage forms

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