Microcrystalline Cellulose (MCC 102) - Pharmaceutical Ingredient
Pharmaceutical USP Grade
Pharmaceutical Ingredient

Microcrystalline Cellulose (MCC 102)

Premium pharmaceutical-grade microcrystalline cellulose engineered for demanding drug formulation applications including tablet binding, direct compression, and disintegration. Our high-performance excipient delivers exceptional binding efficiency, consistent performance, and reliable supply for critical pharmaceutical manufacturing processes requiring superior tablet properties with stringent regulatory compliance standards.

  • USP/EP/IP Grade Compliance
  • 102 μm Average Particle Size
  • ≤5.0% Loss on Drying
  • Superior Binding Properties
  • Direct Compression Compatible
  • Pharmaceutical Grade Quality
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Technical Specifications

Chemical Formula: [C₆H₁₀O₅]ₙ
CAS Number: 9004-34-6
EINECS Number: 232-674-9
Grade: USP/EP/IP Pharmaceutical Grade
Physical State: White crystalline powder
Average Particle Size: 50-102 μm (MCC 102)
Bulk Density: 0.28-0.35 g/cm³
Loss on Drying: ≤ 5.0%
pH (1% suspension): 5.0-7.5
Residue on Ignition: ≤ 0.1%
Heavy Metals (as Pb): ≤ 10 ppm
Total Microbial Count: ≤ 1000 CFU/g
Yeast & Molds: ≤ 100 CFU/g
E. coli: Absent
Salmonella: Absent
Packaging Options: 25kg fiber drums, 500kg bulk bags

Applications

Tablet Binding Agent
Direct Compression
Wet Granulation
Capsule Filler
Suspension Stabilizer
Ophthalmic Preparations
Topical Formulations
Controlled Release Systems
Disintegrant Enhancement
Food Grade Applications
Nutraceutical Products
Pharmaceutical Excipient

Industry-Specific Grades

DRAVYOM offers specialized microcrystalline cellulose grades tailored for different pharmaceutical and nutraceutical requirements, ensuring optimal performance and regulatory compliance across diverse formulation applications.

USP Grade (Pharmaceutical)
Particle Size: 50-102 μm Moisture: ≤ 5.0% pH: 5.0-7.5 Application: Direct compression tablets
EP Grade (European)
Bulk Density: 0.28-0.35 g/cm³ Heavy Metals: ≤ 10 ppm Microbial: ≤ 1000 CFU/g Application: European pharmaceutical markets
Food Grade
E Number: E460 Dietary Fiber: High content Caloric Value: Zero Application: Food additives, diet products
Biomedical Grade
Sterility: Gamma irradiated option Endotoxin: ≤ 0.5 EU/g Biocompatibility: Tested Application: Medical devices, implants

Quality Standards

DRAVYOM's Pharmaceutical Grade Microcrystalline Cellulose is manufactured under cGMP conditions, meeting USP/EP/IP monograph specifications for pharmaceutical excipient applications. Our production ensures consistent batch-to-batch quality and full regulatory compliance.

cGMP Certified Manufacturing
USP/EP/IP Monograph Compliance
102 μm Controlled Particle Size
Pharmaceutical Grade Purity
Complete Analytical Testing
Batch Release Documentation
Temperature-Controlled Storage
Regulatory Change Control

Advanced Chemical Properties & Performance

Pharmaceutical Grade Microcrystalline Cellulose MCC-102 exhibits exceptional binding and disintegration properties essential for tablet formulation. Its controlled particle size and superior compressibility ensure consistent tablet hardness and dissolution performance.

Pharmaceutical Properties
Particle Size (D50): 102 μm (90-120 μm)
Moisture Content: ≤ 5.0% (USP)
pH (1% slurry): 5.0-7.5
Degree of Polymerization: 220-350
Physical Properties
Bulk Density: 0.28-0.35 g/cm³
Tapped Density: 0.35-0.50 g/cm³
Loss on Drying: ≤ 5.0%
Residue on Ignition: ≤ 0.05%
Formulation Performance
Compressibility: Excellent direct compression
Binding Capacity: Superior tablet hardness
Disintegration: Rapid tablet breakdown
Flow Properties: Good to excellent flow
Purity Specifications
Heavy Metals: ≤ 10 ppm
Conductivity: ≤ 75 μS/cm
Microbial Limits: USP/EP compliant
Endotoxins: ≤ 0.5 EU/g
Stability Properties
Shelf Life: 5 years (unopened)
Retest Period: 5 years from manufacture
Storage Stability: Stable under normal conditions
Hygroscopic Nature: Absorbs moisture readily

Performance Characteristics

Performance metrics demonstrate Pharmaceutical Grade MCC-102 excellence in tablet formulation with superior binding properties, consistent compressibility, and reliable disintegration across diverse drug formulations and manufacturing processes.

Compressibility

Tablet hardness: 8-12 kP typical range

Excellent direct compression
Disintegration

Breakdown time: <15 minutes (USP)

Rapid tablet dissolution
Weight Uniformity

Tablet weight variation: ±2% typical

Consistent tablet mass
Flow Properties

Carr's Index: 15-25% (good flow)

Excellent processability
Batch Consistency

Particle size variation: ±5% between batches

Reliable pharmaceutical performance
Stability

Shelf life: 5 years under proper storage

Extended product lifecycle

Safety Information

Microcrystalline Cellulose is generally recognized as safe (GRAS) for pharmaceutical use. Use standard Good Manufacturing Practices (GMP), avoid dust inhalation, and wear appropriate protective equipment during handling. Ensure proper dust control systems in manufacturing areas.

Pharmaceutical Grade
Dust Control
GRAS Status

Storage & Handling

Store in original containers in a cool, dry place with controlled humidity. Protect from moisture and ensure proper sealing after use. Maintain GMP storage conditions and use first-in-first-out inventory rotation. Avoid contamination with other materials.

Store at 15-30°C
Relative humidity <60%
Original packaging preferred
GMP storage conditions

Chemical Mechanisms & Reaction Pathways

Microcrystalline cellulose exhibits unique binding and disintegration properties through hydrogen bonding and capillary action, enabling optimal tablet compression and rapid drug release with predictable pharmaceutical performance.

Compression Mechanism

Plastic deformation and hydrogen bonding during tablet compression processes

Essential for direct compression applications
Disintegration

Rapid water uptake and swelling for tablet disintegration mechanisms

Critical for immediate release formulations
Binding Properties

Excellent dry binding characteristics for tablet cohesion and strength

Enables efficient tablet manufacturing
Surface Activity

High surface area and porosity for drug interaction and processing

Important for drug loading and stability

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures pharmaceutical-grade MCC meets international pharmacopeial standards with complete documentation packages supporting drug development and regulatory submissions.

Pharmacopeial Standards

USP, EP, and JP compliance for pharmaceutical excipient applications

GMP Compliance

Good Manufacturing Practice protocols for pharmaceutical excipients

Safety Documentation

GRAS status and pharmaceutical safety assessment documentation

International Registration

DMF filings and excipient master file documentation

Quality Documentation

Certificates of analysis and pharmaceutical quality certificates

Supply Chain

GMP-compliant transportation and pharmaceutical logistics

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical excipient support team provides comprehensive formulation guidance, technical assistance, and regulatory support to optimize MCC applications in pharmaceutical manufacturing.

Formulation Support
  • Direct compression optimization
  • Tablet binding enhancement
  • Disintegration time control
  • Capsule fill formulation
Technical Services
  • Particle size optimization
  • Compression profile analysis
  • Stability testing guidance
  • Process troubleshooting
Quality Services
  • GMP compliance consultation
  • Method validation support
  • Quality system documentation
  • Pharmacopeial testing protocols
Supply Solutions
  • Pharmaceutical-grade packaging
  • Just-in-time delivery programs
  • Custom particle size grades
  • Inventory management services

Environmental Impact & Sustainability

Our pharmaceutical MCC production emphasizes environmental responsibility through sustainable cellulose sourcing, energy-efficient processing, and comprehensive environmental impact management for sustainable pharmaceutical development.

Sustainable Sourcing

Renewable cellulose sources with sustainable forestry practices

Green Processing

Environmentally friendly microcrystallization processes

Clean Production

Energy-efficient manufacturing with emission controls

Waste Management

Pharmaceutical waste minimization and recycling programs

Environmental Standards

ISO 14001 environmental management system compliance

Packaging Solutions

Recyclable pharmaceutical packaging and container programs

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical MCC manufacturing facility employs advanced microcrystallization technology and quality systems to ensure consistent pharmaceutical-grade quality and performance across all production batches.

Advanced Processing

Controlled microcrystallization and purification technology for consistent quality

Optimal particle size and surface area control
Quality Testing

Comprehensive testing including particle size, surface area, and pharmaceutical properties

USP/EP method validation and compliance
GMP Systems

cGMP compliance with pharmaceutical excipient quality systems

FDA and EMA inspection-ready facilities
Pharmaceutical Packaging

Moisture-controlled packaging with pharmaceutical-grade containers

Stability-optimized packaging systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating MCC effectiveness across tablet manufacturing applications with validated performance metrics and pharmaceutical industry adoption for direct compression.

Tablet Manufacturing
Binding Efficiency: 97% tablet hardness target achievement Performance: Consistent compression properties Customer Satisfaction: 94% pharmaceutical approval
Capsule Applications
Fill Properties: Superior powder flow characteristics Disintegration: Rapid dissolution performance Process Efficiency: 30% compression time reduction
Direct Compression
Process Reliability: 98% batch success rate Cost Effectiveness: 25% formulation cost savings Market Share: 70% excipient binder segment

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

cGMP-compliant MCC manufacturing with pharmaceutical regulatory expertise and formulation support

Processing Innovation

Advanced microcrystallization technology with custom particle size grades and surface optimization

Quality Assurance

Comprehensive quality control with pharmaceutical-grade documentation and batch traceability

Reliable Supply

Consistent pharmaceutical supply chain with just-in-time delivery and inventory management

Regulatory Support

DMF filing assistance with regulatory submission support and global compliance expertise

Partnership Approach

Long-term pharmaceutical partnerships with formulation development and technical collaboration