Microcrystalline Cellulose (MCC) PH101
Pharmaceutical Excipient
Pharmaceutical Products

Microcrystalline Cellulose (MCC) PH101

High-quality Microcrystalline Cellulose PH101 designed for pharmaceutical applications requiring superior binding, compressibility, and disintegration properties. Our premium MCC delivers excellent tablet hardness, outstanding flow characteristics, and reliable pharmaceutical performance for demanding formulation requirements.

  • Excellent Binding Properties
  • Superior Compressibility
  • Outstanding Disintegration
  • Pharmaceutical Grade Quality
  • Excellent Flow Properties
  • USP/EP/BP Compliant
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Technical Specifications

Chemical Formula: (C6H10O5)n
CAS Number: 9004-34-6
Grade Type: PH101 (50μm average particle size)
Physical State: White to off-white powder
Particle Size Distribution: ≤50μm (≥90% through #200 mesh)
pH (1% solution): 5.0-7.5
Loss on Drying: ≤5.0%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Bulk Density: 0.26-0.31 g/cm³
Tapped Density: 0.35-0.46 g/cm³
Degree of Polymerization: ≥350
Storage Conditions: Store in cool, dry place
Shelf Life: 5 years from date of manufacture
Packaging Options: 25kg bags, 500kg drums

Applications

Direct Compression Tablets
Tablet Binding
Disintegrant Agent
Capsule Filling
Pharmaceutical Excipient
Hospital Pharmacies
Pharmaceutical Manufacturing
Oral Solid Dosage Forms
Formulation Research
Clinical Formulations
Regulatory Submissions
Reference Standards

Industry-Specific Grades

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

PH101 Grade (Direct Compression)
Particle Size: ≤50μm (average) Bulk Density: 0.26-0.31 g/cm³ Compressibility: Excellent Application: Direct compression tablets
USP/EP Grade (Pharmaceutical)
pH: 5.0-7.5 Loss on Drying: ≤5.0% Heavy Metals: ≤10 ppm Application: FDA/EU compliant formulations
High-Binding Grade
Degree of Polymerization: ≥350 Enhanced binding properties Superior tablet hardness Application: Binding research
Reference Standard Grade
Certified particle size distribution Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Microcrystalline Cellulose PH101 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
Controlled Particle Size Distribution
Advanced Analytical Testing
Superior Binding Properties
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Controlled Storage Conditions

Advanced Chemical Properties & Performance

Pharmaceutical Grade Microcrystalline Cellulose exhibits exceptional functional properties essential for tablet manufacturing. Its optimal particle size distribution and superior binding characteristics ensure reliable performance in demanding pharmaceutical formulations.

Physical Properties
Bulk Density: 0.26-0.31 g/cm³
Tapped Density: 0.40-0.45 g/cm³
Particle Size Distribution: ≤50μm (average)
Surface Area: 1.0-1.5 m²/g
Thermal Properties
Melting Point: 260-270°C (decomposition)
Glass Transition: ~200°C
Thermal Stability: Stable up to 200°C
Heat of Hydration: -42.1 kJ/mol
Mechanical Properties
Compressibility Index: 15-25% (excellent)
Hausner Ratio: 1.18-1.33
Angle of Repose: 25-40°
Flowability: Good to excellent
Chemical Specifications
pH (1% suspension): 5.0-7.5
Loss on Drying: ≤5.0%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 5 years (unopened)
Moisture Sensitivity: Hygroscopic
Chemical Stability: Stable under normal conditions
Incompatibilities: Strong oxidizing agents

Performance Characteristics

Detailed performance metrics demonstrate Microcrystalline Cellulose PH101 superiority in pharmaceutical applications with exceptional binding properties, flowability, and tablet manufacturing performance across diverse formulation requirements.

Binding Performance

Excellent direct compression binding properties

Superior tablet hardness and integrity
Flow Properties

Good to excellent flowability characteristics

Consistent die filling and weight uniformity
Disintegration

Rapid tablet disintegration in aqueous media

Enhanced drug release profiles
Thermal Stability

Stable under normal manufacturing conditions

Suitable for various processing temperatures
Batch Consistency

Excellent lot-to-lot reproducibility

Reliable manufacturing performance
Tablet Quality

Superior tablet hardness and friability performance

Enhanced pharmaceutical quality

Safety Information

Generally recognized as safe (GRAS) pharmaceutical excipient with excellent safety profile. Avoid excessive dust inhalation and maintain good hygiene practices during handling. Use appropriate personal protective equipment in manufacturing environments.

Avoid Dust Inhalation
Good Hygiene Required
GRAS Status

Storage & Handling

Store in tightly closed containers in a cool, dry place away from moisture and direct sunlight. Maintain ambient temperature storage conditions and ensure protection from humidity to preserve functional properties and pharmaceutical quality.

Room temperature storage (15-25°C)
Protect from moisture and humidity
Tightly closed original containers
Protect from direct sunlight

Chemical Mechanisms & Reaction Pathways

Microcrystalline Cellulose PH101 exhibits unique binding and disintegration properties through hydrogen bonding networks and capillary action mechanisms, enabling precise pharmaceutical applications with superior compactibility and drug release characteristics.

Hydrogen Bonding

Extensive hydrogen bonding between cellulose chains creates strong tablet matrix

Excellent binding properties for direct compression
Capillary Action

Rapid water uptake through capillary channels enables fast disintegration

Enhanced drug release and dissolution profiles
Particle Deformation

Plastic deformation under compression creates strong inter-particle bonds

Superior tablet hardness and mechanical strength
Swelling Mechanism

Controlled swelling promotes tablet disintegration without gelling

Consistent disintegration across various formulations

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

GRAS Status

Generally Recognized as Safe for pharmaceutical and food applications

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, direct compression guidance, and technical solutions to maximize MCC PH101 performance in your pharmaceutical formulations.

Formulation Development
  • Direct compression optimization
  • Tablet hardness and friability improvement
  • Disintegration time optimization
  • Drug loading capacity studies
Analytical Services
  • Particle size distribution analysis
  • Compactibility profiling
  • Flow property testing
  • Moisture content analysis
Technical Support
  • Tableting troubleshooting consultation
  • Manufacturing scale-up guidance
  • Quality control method development
  • Regulatory documentation support
Supply Solutions
  • Multiple grade specifications available
  • Flexible packaging configurations
  • Just-in-time delivery programs
  • Global excipient distribution network

Environmental Impact & Sustainability

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

Renewable Source

Derived from sustainable wood pulp and plant-based cellulose sources

Water Conservation

Advanced water recycling and treatment systems in production

Clean Production

Energy-efficient processing with minimal environmental impact

Biodegradable

Naturally biodegradable excipient with minimal environmental persistence

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 MCC PH101 quality and performance across all production batches.

Production Process

Advanced controlled microcrystallization in clean pharmaceutical environment

Precise particle size control for optimal tablet performance
Quality Testing

Comprehensive testing including compactibility and flow properties

Laser diffraction and texture analysis verification
Quality Systems

ISO 9001:2015 with pharmaceutical excipient manufacturing certification

IPEC-compliant quality management systems
Packaging Control

Pharmaceutical-grade containers with moisture barrier protection

Maintains functionality and prevents degradation

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating MCC PH101 effectiveness across diverse formulation applications with quantified compression, disintegration, and manufacturing performance metrics.

Direct Compression
Compactibility: Excellent binding at low compression forces Disintegration: <15 minutes typical performance Hardness: 4-12 kP tablet strength range
Manufacturing Benefits
Flowability: Good to excellent flow properties Compatibility: Universal API compatibility Efficiency: 30-40% reduction in processing time
Production Performance
Consistency: <5% batch-to-batch variation Yield: >95% tablet production efficiency Cost-Effectiveness: 20% formulation cost reduction

DRAVYOM Competitive Advantages

Superior Quality

Consistently exceeds USP-NF specifications with optimized particle size distribution and functional properties

Reliable Supply

Guaranteed availability with strategic inventory management and multiple-grade production capabilities

Formulation Expertise

Dedicated formulation science team provides direct compression and tablet optimization guidance

Quality Assurance

Comprehensive certificates with complete analytical data and functional property specifications

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom grade development services