Ethylcellulose
Pharmaceutical Premium
Pharmaceutical Excipient

Ethylcellulose

High-purity pharmaceutical Ethylcellulose manufactured to meet stringent USP and EP specifications for controlled release applications. Our Ethylcellulose provides excellent film formation and controlled drug release properties for sustained and modified release dosage forms.

  • USP/EP Pharmaceutical Grade
  • Superior Controlled Release
  • Excellent Film Formation
  • Enhanced Drug Release Control
  • Consistent Quality
  • Ultra-Low Moisture Content
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Technical Specifications

Chemical Formula: [C6H7O2(OH)3-x(OC2H5)x]n
CAS Number: 9004-57-3
Molecular Weight: Variable (20,000-100,000 g/mol)
Ethoxy Content: 44.0-51.0% (pharmaceutical grade)
Physical State: White to slightly yellow powder
Water Content (Karl Fischer): ≤5.0%
Residue on Ignition: ≤0.4%
Heavy Metals (as Pb): ≤10 ppm
Particle Size: Controlled distribution
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 25kg, 50kg pharmaceutical drums

Applications

Controlled Release Formulations
Sustained Release Tablets
Film Coating Applications
Microencapsulation Processes
Matrix Tablet Technology
Pharmaceutical Research
Manufacturing Processes
Quality Control Testing
Regulatory Compliance
Formulation Development
Drug Release Studies
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Ethylcellulose grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse controlled release and coating applications.

Standard Viscosity Grade
Ethoxy Content: 48.0-49.5% Viscosity: 10-15 cP Particle Size: Standard Application: General controlled release
High Viscosity Grade
Ethoxy Content: 48.0-49.5% Viscosity: 45-55 cP Molecular Weight: Higher Application: Extended release formulations
Fine Particle Grade
Ethoxy Content: 48.0-49.5% Particle Size: Fine distribution Enhanced Dissolution Application: Film coating
Micronized Grade
Ethoxy Content: 48.0-49.5% Particle Size: Micronized Enhanced Processing Application: Matrix tablets

Quality Standards

DRAVYOM's pharmaceutical grade Ethylcellulose is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
Consistent Ethoxy Content
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Ethylcellulose exhibits exceptional chemical properties essential for controlled-release pharmaceutical applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Insoluble
Ethoxy Content: 48.0-49.5%
Viscosity: 4-100 cP (5% solution)
Molecular Weight: Variable (polymer)
Physical Properties
Appearance: White to off-white powder
Glass Transition: 130-135°C
Bulk Density: 0.3-0.6 g/mL
Particle Size: Micronized (≤20 μm)
Pharmaceutical Performance
Film Formation: Excellent coating properties
Drug Release Control: Sustained release profiles
Compatibility: Wide range of APIs
Processing: Hot melt extrusion compatible
Purity Specifications
Ethoxy Content: 48.0-49.5%
Loss on Drying: ≤3.0%
Residue on Ignition: ≤0.4%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Minimal photodegradation
Temperature Stability: Stable up to 130°C
Moisture Sensitivity: Minimal hygroscopicity

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Ethylcellulose superiority in controlled-release applications with exceptional film formation, drug release control, and reproducibility across diverse pharmaceutical formulations.

Film Formation

Excellent coating and film properties

Uniform barrier formation
Release Control

Precise drug release modulation

Sustained release profiles
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains properties for 5 years
Thermal Stability

Glass transition: 130-135°C

Stable during processing
Batch Reproducibility

Variation: ±0.2% between batches

Consistent performance
Formulation Compatibility

Compatible with wide range of APIs

Versatile excipient

Safety Information

Pharmaceutical excipient requiring standard handling protocols. Well-established safety profile for pharmaceutical applications. Handle with appropriate dust control precautions and ensure proper GMP environmental controls. Monitor for dust generation and maintain adequate ventilation during processing.

Dust Control
Professional Use
Adequate ventilation required

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate dust control measures and GMP handling techniques.

Cool storage (15-25°C)
Protect from moisture
Adequate ventilation
GMP handling required

Chemical Mechanisms & Reaction Pathways

Ethylcellulose serves as a pharmaceutical excipient through its film-forming properties, controlled-release mechanisms, and tablet coating applications, providing sustained drug delivery and pharmaceutical formulation enhancement.

Film Formation

Forms flexible, water-resistant films for tablet coating

Controlled-release drug delivery
Matrix Properties

Creates inert matrix for sustained drug release

Extended-release formulations
Binding Enhancement

Improves tablet binding and mechanical strength

Pharmaceutical tablet integrity
Enteric Properties

Provides pH-dependent drug release control

Targeted drug delivery

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures pharmaceutical excipient manufacturing access with complete documentation packages supporting international standards and controlled-release formulation development.

USP-NF Standards

United States Pharmacopeia pharmaceutical excipient specifications

Ph.Eur. Monograph

European Pharmacopoeia specifications for ethylcellulose

Pharmaceutical GMP

Good Manufacturing Practices for pharmaceutical excipients

ICH Guidelines

International pharmaceutical excipient regulatory compliance

Excipient DMF

Drug Master File for pharmaceutical excipient applications

Safety Documentation

Comprehensive excipient safety and compatibility documentation

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical excipient team provides comprehensive formulation support, controlled-release optimization, and regulatory services for Ethylcellulose pharmaceutical applications.

Formulation Development
  • Controlled-release formulation optimization
  • Tablet coating development
  • Matrix tablet design
  • Custom excipient blend development
Analytical Services
  • Excipient purity and specifications
  • Dissolution testing protocols
  • Film formation characterization
  • Method validation support
Regulatory Support
  • Pharmaceutical excipient regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Excipient pharmacovigilance
Supply Solutions
  • Pharmaceutical grade supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency pharmaceutical supply

Environmental Impact & Sustainability

Our Ethylcellulose production emphasizes environmental responsibility through sustainable cellulose sourcing, eco-friendly manufacturing processes, and comprehensive environmental impact management.

Sustainable Sourcing

Renewable cellulose feedstock from sustainable sources

Water Conservation

Efficient water usage in pharmaceutical grade production

Clean Production

Energy-efficient pharmaceutical excipient manufacturing

Waste Reduction

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Biodegradable

Environmentally friendly biodegradable excipient

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical excipient facility employs advanced polymer processing technology and continuous monitoring systems to ensure consistent Ethylcellulose quality and pharmaceutical grade performance.

Pharmaceutical GMP

Pharmaceutical grade manufacturing in controlled environment

Multi-stage purification for pharmaceutical purity
Quality Testing

Comprehensive testing including viscosity, purity, and performance

Physical and chemical characterization
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and pharmaceutical validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with moisture protection

Quality protection and stability maintenance

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Ethylcellulose effectiveness in controlled-release formulations with quantified performance metrics and application validation data.

Pharmaceutical Applications
Viscosity: 10-15 cP pharmaceutical grade Purity: >99% pharmaceutical specification Film Formation: Excellent coating properties
Controlled Release
Matrix Tablets: Sustained drug release Coating: Enteric and controlled-release coating Granulation: Binding and coating applications
Manufacturing Performance
Yield: 97% pharmaceutical grade recovery Purity: >99.5% pharmaceutical specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Superior pharmaceutical grade ethylcellulose with proven controlled-release performance

Reliable Supply

Guaranteed pharmaceutical grade supply with strategic inventory management

Formulation Expertise

Dedicated controlled-release development team with specialized formulation support

Regulatory Compliance

Complete pharmaceutical documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, Ph.Eur., and ICH guidelines

Partnership Approach

Collaborative pharmaceutical relationships with specialized development services