Sodium Stearyl Fumarate
Pharmaceutical Premium
Pharmaceutical Excipient

Sodium Stearyl Fumarate

High-purity pharmaceutical Sodium Stearyl Fumarate manufactured to meet stringent USP and EP specifications for tablet formulation. Our SSF provides excellent lubrication properties with superior flow characteristics and enhanced tablet compression performance.

  • USP/EP Pharmaceutical Grade
  • Superior Lubrication Properties
  • Excellent Flow Properties
  • Enhanced Tablet Compression
  • Consistent Quality
  • Ultra-Low Impurities
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Technical Specifications

Chemical Formula: C22H42NaO4
CAS Number: 4070-80-8
EINECS Number: 223-795-8
Molecular Weight: 393.57 g/mol
Physical State: White to off-white powder
Purity (as sodium salt): ≥98.0% (USP/EP Grade)
pH (1% suspension): 6.0-8.0
Loss on Drying: ≤2.0%
Heavy Metals (as Pb): ≤10 ppm
Bulk Density: 0.2-0.4 g/mL
Particle Size: 90% through 200 mesh
Solubility: Practically insoluble in water
Storage Conditions: Store in cool, dry place
Shelf Life: 3 years from date of manufacture
Packaging Options: 25kg, 50kg pharmaceutical grade drums

Applications

Tablet Lubrication
Capsule Formulations
Compression Aid
Flow Enhancement
Pharmaceutical Excipient
Manufacturing Aid
Direct Compression
Oral Dosage Forms
Formulation Development
Process Optimization
Quality Enhancement
Regulatory Compliance

Industry-Specific Grades

DRAVYOM offers specialized Sodium Stearyl Fumarate grades tailored for specific pharmaceutical lubricant requirements, ensuring optimal performance and regulatory compliance across diverse tablet formulation applications.

USP Grade (United States Pharmacopeia)
Purity: ≥98.0% (as sodium salt) Loss on Drying: ≤2.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (as sodium salt) pH: 6.0-8.0 (1% suspension) Particle Size: 90% through 200 mesh Application: EU regulatory submissions
Compression Grade
Purity: ≥99.0% (as sodium salt) Bulk Density: 0.2-0.4 g/mL Flow Properties: Excellent Application: Direct compression tablets
Research Grade
Purity: ≥99.5% (as sodium salt) Particle Size: Controlled Documentation: Research COA Application: R&D applications

Quality Standards

DRAVYOM's Sodium Stearyl Fumarate is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP and EP specifications. Our pharmaceutical-grade production ensures consistent lubricant performance and regulatory compliance.

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥98.0% Purity (as sodium salt)
Advanced Excipient Testing
Controlled Particle Size
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Sodium Stearyl Fumarate exhibits exceptional lubricant properties essential for pharmaceutical tablet formulations. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding tableting operations.

Molecular Properties
Molecular Weight: 390.56 g/mol
LogP: 6.8
pKa: 3.02
Lubrication Index: Superior
Physical Properties
Melting Point: 140-145°C
Solubility (Water): Practically insoluble
Particle Size: Fine powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Lubrication Efficiency: Excellent
Anti-sticking Properties: Superior
Selectivity: Tablet lubricant
Stability: Stable in solid state
Purity Specifications
Assay: ≥98.0%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable at room temperature
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Sodium Stearyl Fumarate superiority in tablet lubrication with exceptional anti-sticking properties, flow enhancement, and reproducibility across diverse formulations.

Lubrication Efficiency

Ejection force reduction: >50%

Superior tablet lubrication
Flow Properties

Carr's Index: <15% (excellent flow)

Enhanced powder flowability
Stability

Solid state: >5 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during tableting
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade excipient requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for pharmaceutical excipients and ensure proper waste disposal procedures.

Pharmaceutical Excipient
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical excipient handling.

Cool storage (2-8°C)
Protect from light
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Sodium Stearyl Fumarate exhibits specific lubricant and anti-adherent mechanisms essential for pharmaceutical tablet manufacturing. Its molecular structure enables effective lubrication with minimal impact on tablet dissolution and pharmaceutical performance.

Lubrication Mechanism

Metallic stearate lubrication with effective tablet ejection

Reduced tablet sticking
Anti-adherent Properties

Prevents tablet sticking to punch faces and die walls

Improved tablet quality
Dissolution Impact

Minimal interference with tablet dissolution profile

Enhanced bioavailability
Compaction Enhancement

Improved tablet compressibility and hardness

Optimal tablet performance

Regulatory 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 quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation support.

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

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