Shellac
High-purity pharmaceutical Shellac manufactured to meet stringent USP and EP specifications for enteric coating applications. Our Shellac provides excellent gastric resistance and natural film formation properties for targeted drug delivery systems.
- USP/EP Pharmaceutical Grade
- Superior Enteric Properties
- Excellent Film Formation
- Enhanced Gastric Resistance
- Consistent Quality
- Natural Origin
Technical Specifications
Applications
Industry-Specific Grades
DRAVYOM offers specialized Shellac grades tailored for specific coating applications, ensuring optimal film formation and regulatory compliance across diverse pharmaceutical formulations.
USP Grade (United States Pharmacopoeia)
EP Grade (European Pharmacopoeia)
Research Grade
Enteric Grade
Quality Standards
DRAVYOM's Shellac is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for coating applications.
Advanced Chemical Properties & Performance
Pharmaceutical Grade Shellac exhibits exceptional chemical properties essential for coating applications. Its natural polymeric resin structure and superior film-forming characteristics ensure reliable performance in demanding enteric coating and sustained-release formulations.
Molecular Properties
Physical Properties
Pharmaceutical Properties
Quality Specifications
Stability Properties
Performance Characteristics
Detailed performance metrics demonstrate Shellac superiority in coating applications with exceptional film formation, enteric protection, and sustained-release capabilities across diverse pharmaceutical dosage form development protocols.
Enteric Protection
Gastric acid resistant coating properties
pH-dependent dissolution controlFilm Formation
Excellent film-forming characteristics
Uniform coating applicationsSustained Release
Controlled drug release profiles
Extended therapeutic actionMoisture Barrier
Effective moisture protection
Enhanced stability protectionNatural Origin
Natural polymer from lac resin
Biocompatible coating materialRegulatory Status
USP/EP grade pharmaceutical shellac
Global regulatory acceptanceSafety Information
Natural pharmaceutical excipient requiring standard handling protocols. Handle in controlled environments with appropriate dust control measures. Use proper personal protective equipment and follow established safety protocols for coating materials.
Storage & Handling
Store in tightly closed containers in a cool, dry, dark place away from direct sunlight. Maintain controlled room temperature storage and ensure protection from moisture and humidity to preserve coating performance and pharmaceutical quality.
Chemical Mechanisms & Reaction Pathways
Shellac exhibits specific film-forming polymer mechanisms essential for pharmaceutical coating applications. Its molecular structure enables excellent enteric coating properties with predictable drug release therapeutic responses.
Film Formation
Natural resinous polymer coating with pH-dependent solubility
Enteric coating protectionDissolution Behavior
Alkaline pH-dependent dissolution in intestinal environment
Gastric acid protectionBarrier Properties
Effective moisture and acid protection for active ingredients
Controlled drug releaseCoating Performance
Uniform film formation with excellent adhesion properties
Pharmaceutical coating qualityRegulatory Compliance & Documentation
Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international drug development and manufacturing standards.
USP Specifications
United States Pharmacopeia pharmaceutical standards compliance
EP Standards
European Pharmacopoeia specifications for pharmaceutical quality
ICH Guidelines
International Conference on Harmonization standards compliance
GMP Certification
Good Manufacturing Practices certified production facility
DMF Support
Drug Master File documentation for regulatory submissions
CEP Available
Certificate of Suitability to European Pharmacopoeia monographs
Technical Support & Value-Added Services
DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.
Formulation Development
- Dosage form optimization support
- Stability testing guidance
- Bioavailability enhancement
- Custom formulation development
Analytical Services
- Method development and validation
- Impurity profiling and identification
- Stability indicating methods
- Dissolution testing support
Regulatory Support
- Regulatory submission assistance
- DMF preparation and maintenance
- Pharmacovigilance support
- Global registration strategy
Supply Solutions
- Pharmaceutical supply chain management
- Cold chain logistics
- Custom packaging solutions
- Global distribution network
Environmental Impact & Sustainability
Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.
Green Chemistry
Sustainable synthetic routes with minimal environmental impact
Water Management
Advanced wastewater treatment and recycling systems
Clean Production
Energy-efficient synthesis with emission controls
Safe Disposal
Comprehensive pharmaceutical waste management protocols
ISO 14001
Environmental management system certified production
Sustainable Packaging
Recyclable pharmaceutical packaging solutions
Manufacturing Excellence & Quality Control
DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent pharmaceutical quality and performance across all production batches.
Production Process
Advanced synthesis and purification in GMP-controlled clean-room environment
Multi-stage purification for pharmaceutical grade qualityQuality Testing
Comprehensive testing protocol including purity, potency, and impurity profiling
HPLC, GC-MS, and spectroscopic analysisQuality Systems
ISO 9001:2015 and GMP quality management systems
Continuous improvement and validation protocolsPackaging Control
Pharmaceutical-grade packaging with controlled atmosphere
Contamination prevention and stability protectionMarket Applications & Performance Data
Comprehensive pharmaceutical development data demonstrating effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation support.
Pharmaceutical Development
Research Applications
Commercial Manufacturing
DRAVYOM Competitive Advantages
Pharmaceutical Excellence
Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance
Reliable Supply
Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling
Development Expertise
Dedicated pharmaceutical development team provides formulation and regulatory support
Regulatory Assurance
Complete regulatory packages with DMF support and global registration assistance
Global Standards
International compliance with USP, EP, and ICH standards for worldwide market access
Partnership Approach
Collaborative relationships with pharmaceutical companies and custom development services