Magnesium Stearate USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Magnesium Stearate USP/EP

High-purity pharmaceutical grade Magnesium Stearate manufactured under stringent cGMP conditions. This essential lubricant excipient is critical for pharmaceutical manufacturing, preventing tablet sticking and ensuring smooth tablet production, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Optimal Lubrication Properties
  • Comprehensive COA Documentation
  • Essential Tablet Lubricant
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: Mg(C18H35O2)2
CAS Number: 557-04-0
EINECS Number: 209-150-3
Molecular Weight: 591.24 g/mol
Physical State: White or off-white fine powder
Purity (NF): ≥98.0% (USP/EP Grade)
Melting Range: 117-150°C
Loss on Drying: ≤6.0%
Acid Value: ≤7.0
Heavy Metals (as Pb): ≤10 ppm
Bulk Density: 0.15-0.25 g/cm³
Particle Size (D90): ≤75 μm
Storage Conditions: Store in cool, dry place
Shelf Life: 5 years from date of manufacture
Packaging Options: 25kg drums, 50kg containers

Applications

Tablet Lubrication
Capsule Manufacturing
Pharmaceutical Excipient
Flow Aid Agent
Direct Compression
Hospital Pharmacies
Pharmaceutical Manufacturing
Anti-adherent Properties
Formulation Research
Clinical Formulations
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Magnesium Stearate grades tailored for specific pharmaceutical excipient requirements, ensuring optimal performance and regulatory compliance across diverse tablet manufacturing applications.

USP Grade (United States Pharmacopeia)
Purity: ≥98.0% (NF) Loss on Drying: ≤6.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (EP) Acid Value: ≤7.0 Particle Size: ≤75 μm Application: EU regulatory submissions
Pharmaceutical Research Grade
Purity: ≥99.0% (NF) Ultra-fine particle size Optimal lubrication properties Application: Formulation research
Reference Standard Grade
Purity: ≥99.5% (NF) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

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

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥98.0% NF Purity
Advanced Analytical Testing
Optimal Lubrication Properties
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Controlled Storage Conditions

Advanced Chemical Properties & Performance

Magnesium Stearate exhibits exceptional pharmaceutical properties essential for tablet lubrication applications. Its ultra-pure composition and optimal particle size ensure reliable performance in demanding pharmaceutical formulations and manufacturing processes.

Pharmaceutical Properties
Molecular Weight: 591.24 g/mol
Solubility (Water): Practically insoluble
Melting Point: 132°C (decomposes)
Lubrication Efficiency: 0.25-1.0% effective
Physical Properties
Appearance: Fine white powder
Particle Size: 10-20 µm average
Bulk Density: 0.15-0.25 g/mL
Surface Area: 3-7 m²/g
Formulation Performance
Lubrication: Excellent anti-adherent
Tablet Ejection: Smooth ejection force
Mixing Time: 2-5 minutes optimal
Compatibility: Universal compatibility
Purity Specifications
Total Impurities: ≤2.0%
Palmitic Acid: ≤7.0%
Heavy Metals: ≤10 ppm
Loss on Drying: ≤6.0%
Stability Properties
Shelf Life: 5 years (unopened)
Moisture Sensitivity: Store below 65% RH
Temperature Stability: Stable 15-30°C
Chemical Stability: Chemically inert

Performance Characteristics

Detailed performance metrics demonstrate Magnesium Stearate superiority in pharmaceutical applications with exceptional lubrication efficiency, compatibility, and reproducibility across diverse formulation types and manufacturing processes.

Lubrication Performance

Efficiency: 0.25-1.0% effective concentration

Excellent anti-adherent properties
Tablet Ejection

Force reduction: 50-80% improvement

Smooth tablet ejection
Analytical Performance

Purity: ≥98.0% NF grade

Superior analytical precision
Stability Performance

Shelf life: 5 years under proper storage

Extended pharmaceutical integrity
Batch Reproducibility

Variation: ±3.0% between batches

Exceptional lot-to-lot consistency
Compatibility

Universal compatibility with APIs

No adverse interactions

Safety Information

Pharmaceutical grade excipient requiring appropriate handling procedures. Use standard pharmaceutical safety protocols including proper ventilation, protective equipment, and trained personnel. Avoid dust generation and inhalation. Follow all applicable regulatory guidelines for pharmaceutical manufacturing and handling.

Pharmaceutical Excipient
Avoid Dust Inhalation
cGMP Compliance

Storage & Handling

Store in original pharmaceutical packaging in a dry, well-ventilated area. Maintain controlled temperature and humidity conditions. Protect from moisture and contamination. Use appropriate dust control measures and ensure proper documentation for pharmaceutical traceability and regulatory compliance.

Controlled temperature (15-30°C)
Low humidity (≤65% RH)
Dust control measures
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Magnesium Stearate exhibits unique lubricant properties through molecular film formation on pharmaceutical surfaces, enabling precise tablet manufacturing with predictable flow and compression characteristics.

Surface Lubrication

Forms thin molecular films on particle surfaces reducing friction

Prevents tablet sticking and improves ejection
Hydrophobic Coating

Creates hydrophobic surface layer on active ingredients

May affect dissolution profiles if overused
Particle Interaction

Reduces inter-particle adhesion and cohesion forces

Improves powder flowability and blending
Die Wall Interaction

Minimizes adhesion between powder and tooling surfaces

Reduces compression force requirements

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and excipient regulatory requirements.

USP-NF Specifications

United States Pharmacopeia-National Formulary excipient standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical excipients

cGMP Manufacturing

Current Good Manufacturing Practice certified excipient production

IPEC Guidelines

International Pharmaceutical Excipients Council quality standards

CEP Certificate

Certificate of Suitability to European Pharmacopoeia Monograph

Safety Documentation

Complete safety and toxicological data package

Technical Support & Value-Added Services

DRAVYOM's formulation science team provides comprehensive excipient application support, tablet optimization guidance, and technical solutions to maximize Magnesium Stearate performance in your pharmaceutical formulations.

Formulation Optimization
  • Lubricant level optimization studies
  • Tablet hardness and friability improvement
  • Dissolution profile optimization
  • Compression force reduction strategies
Analytical Services
  • Particle size distribution analysis
  • Surface area and flow properties testing
  • Lubricant efficiency evaluation
  • Compatibility studies with APIs
Technical Support
  • Tableting troubleshooting consultation
  • Manufacturing scale-up guidance
  • Quality control method development
  • Regulatory documentation support
Supply Solutions
  • Consistent grade specifications
  • Flexible packaging configurations
  • Just-in-time delivery programs
  • Global excipient distribution network

Environmental Impact & Sustainability

Our Magnesium Stearate production emphasizes environmental responsibility through sustainable excipient manufacturing practices, renewable raw material sourcing, and comprehensive environmental impact management.

Vegetable Source

Derived from renewable vegetable stearic acid sources

Water Conservation

Advanced water recycling and treatment systems

Clean Production

Energy-efficient synthesis with minimal environmental impact

Waste Reduction

Optimized production with minimal waste generation

ISO 14001

Environmental management system certified production

Carbon Footprint

Optimized logistics and regional sourcing strategies

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art excipient manufacturing facility employs advanced processing technology and continuous monitoring systems to ensure consistent Magnesium Stearate quality and performance across all production batches.

Production Process

Advanced synthesis and milling in controlled clean-room environment

Precise particle size control for optimal lubrication
Quality Testing

Comprehensive testing including specific surface area and flow properties

Laser diffraction and BET surface area analysis
Quality Systems

ISO 9001:2015 with pharmaceutical excipient manufacturing certification

IPEC-compliant quality management systems
Packaging Control

Pharmaceutical-grade containers with moisture protection

Prevents agglomeration and maintains flowability

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating Magnesium Stearate effectiveness across diverse tablet formulations with quantified lubrication performance and manufacturing efficiency metrics.

Tablet Manufacturing
Lubrication: 0.25-1.0% effective concentration Compression: 30-50% force reduction Ejection: 95% improvement in tablet release
Formulation Development
Flowability: 25-40% improvement in blend flow Uniformity: <2% weight variation improvement Compatibility: Universal API compatibility
Production Efficiency
Throughput: 20-35% production speed increase Tooling Life: 200% extension of punch life Reject Rate: 80% reduction in tablet defects

DRAVYOM Competitive Advantages

Superior Quality

Consistently exceeds USP-NF specifications with optimized particle size distribution and lubrication efficiency

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade excipient production

Formulation Expertise

Dedicated formulation science team provides tablet optimization and lubrication guidance

Quality Assurance

Comprehensive certificates with complete analytical data and regulatory compliance documentation

Global Standards

International compliance with USP-NF, EP, and IPEC specifications for worldwide pharmaceutical acceptance

Partnership Approach

Collaborative relationships with tablet manufacturers and custom excipient development services