Stearic Acid
Pharmaceutical USP/EP
Pharmaceutical Excipient

Stearic Acid

Premium pharmaceutical grade lubricant manufactured to meet stringent USP and EP specifications for tablet and capsule formulations. Provides excellent lubrication properties with sustained release capabilities and consistent performance in pharmaceutical manufacturing.

  • USP/EP Grade Compliance
  • Excellent Lubrication Properties
  • Sustained Release Applications
  • Superior Flow Characteristics
  • Low Moisture Content
  • High Purity Grade
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Technical Specifications

Chemical Formula: C18H36O2
CAS Number: 57-11-4
EINECS Number: 200-313-4
Molecular Weight: 284.48 g/mol
Physical State: White to off-white crystalline powder
Purity: ≥98.0% (USP/EP Grade)
Melting Point: 68-71°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Iodine Value: ≤3.0
Storage Conditions: Store in cool, dry place
Shelf Life: 3 years from date of manufacture
Packaging Options: 25kg, 50kg pharmaceutical drums

Applications

Tablet Lubrication
Capsule Formulations
Sustained Release Systems
Compression Aid
Pharmaceutical Excipient
Pharmaceutical Manufacturing
Emulsifying Agent
Tablet Coating
Stabilizing Agent
Drug Delivery Systems
Granulation Aid
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Stearic Acid grades tailored for specific pharmaceutical manufacturing requirements, ensuring optimal lubrication performance and regulatory compliance across diverse formulation applications.

USP Grade (United States Pharmacopeia)
Purity: ≥98.0% Iodine Value: ≤3.0 Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% Acid Value: 200-210 Loss on Drying: ≤0.5% Application: EU regulatory submissions
Pharmaceutical Research Grade
Purity: ≥99.0% Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Research formulations
Reference Standard Grade
Purity: ≥99.5% Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Stearic Acid is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP, and cGMP specifications. Our pharmaceutical-grade production ensures consistent lubrication performance and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥98.0% Purity
Advanced Analytical Testing
Ultra-Low Moisture Content
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Storage

Advanced Chemical Properties & Performance

Pharmaceutical Grade Stearic Acid exhibits exceptional chemical properties essential for pharmaceutical applications. Its saturated fatty acid composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and lubrication systems.

Chemical Properties
Molecular Formula: C₁₈H₃₆O₂
Molecular Weight: 284.48 g/mol
Acid Value: 196-212 mg KOH/g
Iodine Value: ≤ 4.0
Physical Properties
Melting Point: 68-72°C
Congealing Point: 54-62°C
Density (70°C): 0.847 g/cm³
Solubility: Soluble in ethanol, ether
Pharmaceutical Performance
Lubrication Efficiency: 0.5-2.0% effective concentration
Tablet Ejection Force: 50-80% reduction
Hardness Impact: Minimal reduction at optimal levels
Disintegration Impact: Controlled release enhancement
Purity Specifications
Stearic Acid Content: ≥ 98.0%
Palmitic Acid: ≤ 7.0%
Heavy Metals: ≤ 10 ppm
Water Content: ≤ 0.5%
Stability Properties
Shelf Life: 5 years (unopened)
Oxidation Stability: Good (saturated fatty acid)
Temperature Stability: Stable 15-25°C
Humidity Stability: Low moisture absorption

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Stearic Acid superiority in lubrication applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and manufacturing protocols.

Lubrication Performance

Efficiency: 50-80% reduction in ejection force

Superior die wall lubrication
Tablet Quality

Impact: Minimal hardness reduction at optimal levels

Maintained mechanical strength
Processing Stability

Range: Stable during tablet compression

Consistent lubrication throughout production
Dosage Uniformity

Mixing: Excellent powder flow enhancement

Improved content uniformity
Batch Consistency

Variation: ±1% between production batches

Exceptional pharmaceutical grade uniformity
Long-term Performance

5 years shelf life with maintained lubrication

Extended pharmaceutical grade integrity

Safety Information

Generally recognized as safe (GRAS) for pharmaceutical and food applications. Non-toxic fatty acid with excellent biocompatibility. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

GRAS Status
Biocompatible
Non-Toxic

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from oxidizing materials. Keep containers tightly closed and protect from moisture and direct sunlight. Use appropriate pharmaceutical handling procedures and ensure proper environmental controls for temperature management.

Cool storage (15-25°C)
Low humidity (≤60% RH)
Original sealed containers
Protect from direct sunlight

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Stearic Acid exhibits unique fatty acid properties through long-chain saturated structure enabling versatile pharmaceutical applications with predictable lubrication and hydrophobic mechanisms in drug formulations.

Lubrication Mechanism

Boundary lubrication through molecular orientation at surfaces

Essential for tablet ejection and die lubrication
Hydrophobic Properties

Water-repelling characteristics for moisture protection

Critical for tablet coating and stability
Metal Complexation

Forms metallic stearates for enhanced lubrication

Enables improved flow and anti-caking properties
Thermal Behavior

Predictable melting point for processing optimization

Fundamental for hot-melt extrusion applications

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international standards and pharmaceutical manufacturing validations.

USP Specifications

United States Pharmacopeia pharmaceutical excipient standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical applications

GRAS Status

Generally Recognized as Safe for pharmaceutical use

REACH Registration

European Union chemical regulation compliance

DMF Support

Drug Master File documentation for regulatory submissions

cGMP Certified

Current Good Manufacturing Practice compliance

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, lubrication optimization assistance, and regulatory services to optimize Pharmaceutical Grade Stearic Acid performance in your specific drug formulations.

Formulation Development
  • Lubrication optimization support
  • Tablet formulation guidance
  • Processing parameter optimization
  • Custom grade development
Analytical Services
  • Certificate of Analysis verification
  • Particle size analysis
  • Purity and impurity testing
  • Thermal analysis support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Processing optimization guidance
  • Storage and handling protocols
  • Manufacturing best practices
Supply Solutions
  • Consistent pharmaceutical-grade supply
  • Flexible packaging options
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Stearic Acid production emphasizes environmental responsibility through sustainable palm oil sourcing, renewable feedstock utilization, and comprehensive environmental impact management for pharmaceutical operations.

Sustainable Sourcing

RSPO-certified palm oil with sustainable agricultural practices

Circular Economy

Complete utilization of vegetable oil by-products

Clean Production

Energy-efficient fractional distillation with minimal waste

Water Conservation

Closed-loop water systems with treatment and recycling

ISO 14001

Environmental management system certified production

Biodegradable

Completely biodegradable with minimal environmental impact

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical excipient manufacturing facility employs advanced fractionation technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Stearic Acid quality and performance across all production batches.

Production Process

Advanced fractional distillation and crystallization in pharmaceutical-grade environment

Multi-stage purification for pharmaceutical purity
Quality Testing

18-point pharmaceutical testing protocol including fatty acid profile and melting point

GC analysis and thermal characterization
Quality Systems

cGMP compliance with pharmaceutical excipient standards

Continuous improvement and process validation
Packaging Control

Moisture-barrier packaging with inert atmosphere protection

Oxidation prevention and contamination control

Market Applications & Performance Data

Comprehensive pharmaceutical formulation data demonstrating Pharmaceutical Grade Stearic Acid effectiveness across diverse applications with quantified performance metrics and regulatory validations.

Tablet Manufacturing
Lubrication: 90% ejection force reduction Processing: Improved tablet quality Efficiency: 25% faster production
Capsule Formulations
Flow Properties: Enhanced powder flow Anti-caking: Prevents agglomeration Stability: Extended shelf life
Coating Applications
Moisture Protection: 95% barrier efficiency Film Formation: Uniform coating Release Profile: Controlled dissolution

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds USP specifications with optimal fatty acid profile and minimal impurities

Reliable Supply

Guaranteed availability with sustainable sourcing partnerships and pharmaceutical-grade production

Formulation Expertise

Dedicated pharmaceutical team provides lubrication optimization and processing support

Quality Assurance

Comprehensive testing with pharmaceutical documentation and regulatory support

Global Standards

International compliance with USP, EP, and cGMP specifications for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services