Mannitol
Pharmaceutical Excipient
Pharmaceutical Products

Mannitol

High-purity Mannitol designed for pharmaceutical applications requiring superior diluent and sweetening properties. Our premium mannitol delivers excellent compressibility, outstanding flowability, and reliable pharmaceutical performance for advanced tablet formulations and drug delivery systems.

  • Excellent Compressibility
  • Superior Flowability
  • Outstanding Sweetening Properties
  • Pharmaceutical Grade Purity
  • Low Hygroscopicity
  • USP/EP/BP Compliant

Technical Specifications

Chemical Formula: C6H14O6
CAS Number: 69-65-8
EINECS Number: 200-711-8
Molecular Weight: 182.17 g/mol
Physical State: White crystalline powder
Purity (HPLC): ≥98.0% (USP/EP Grade)
Melting Point: 165-168°C
pH (5% solution): 5.5-7.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤5 ppm
Chloride: ≤50 ppm
Storage Conditions: Store in cool, dry place
Shelf Life: 3 years from date of manufacture
Packaging Options: 25kg bags, 500kg drums

Applications

Tablet Formulations
Capsule Filling
Direct Compression
Pharmaceutical Excipient
Osmotic Formulations
Hospital Pharmacies
Pharmaceutical Manufacturing
Sweetening Agent
Formulation Research
Clinical Formulations
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Mannitol grades tailored for specific pharmaceutical excipient requirements, ensuring optimal performance and regulatory compliance across diverse formulation applications.

USP Grade (United States Pharmacopeia)
Purity: ≥98.0% (HPLC) Loss on Drying: ≤0.5% Heavy Metals: ≤5 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (HPLC) Chloride: ≤50 ppm Residue on Ignition: ≤0.1% Application: EU regulatory submissions
Direct Compression Grade
Purity: ≥99.0% (HPLC) Optimal flowability Enhanced compressibility Application: Direct compression tablets
Reference Standard Grade
Purity: ≥99.5% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Mannitol 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% HPLC Purity
Advanced Analytical Testing
Superior Compressibility
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Controlled Storage Conditions

Advanced Chemical Properties & Performance

Mannitol exhibits exceptional pharmaceutical properties essential for tablet excipient applications. Its ultra-pure composition and optimal crystalline structure ensure reliable performance in demanding pharmaceutical formulations and direct compression processes.

Pharmaceutical Properties
Molecular Weight: 182.17 g/mol
Solubility (Water): Freely soluble
Melting Point: 165-168°C
Compressibility: Excellent direct compression
Physical Properties
Appearance: White crystalline powder
Particle Size: 25-180 µm typical
Bulk Density: 0.43-0.52 g/mL
Flow Properties: Good to excellent
Formulation Performance
Compactibility: Superior tablet hardness
Disintegration: Fast disintegration time
Sweetness Level: 50% relative to sucrose
Compatibility: Universal API compatibility
Purity Specifications
Total Impurities: ≤2.0%
Reducing Substances: ≤0.5%
Heavy Metals: ≤5 ppm
Chloride: ≤50 ppm
Stability Properties
Shelf Life: 5 years (unopened)
Hygroscopicity: Non-hygroscopic
Temperature Stability: Stable 15-30°C
Chemical Stability: Chemically stable

Performance Characteristics

Detailed performance metrics demonstrate Mannitol superiority in pharmaceutical applications with exceptional compressibility, flowability, and reproducibility across diverse formulation types and manufacturing processes.

Compressibility Performance

Direct compression: Excellent tablet formation

Superior tablet hardness and integrity
Dissolution Performance

Disintegration: Fast breakdown in water

Rapid drug release enhancement
Analytical Performance

Purity: ≥98.0% HPLC

Superior analytical precision
Stability Performance

Shelf life: 5 years under proper storage

Extended pharmaceutical integrity
Batch Reproducibility

Variation: ±2.0% between batches

Exceptional lot-to-lot consistency
Flow Performance

Flowability: Good to excellent flow

Superior manufacturing efficiency

Safety Information

Pharmaceutical grade excipient with excellent safety profile. Generally recognized as safe (GRAS) for pharmaceutical use. Use standard pharmaceutical safety protocols including proper ventilation, protective equipment, and trained personnel. Follow all applicable regulatory guidelines for pharmaceutical manufacturing and handling.

Pharmaceutical Excipient
GRAS Status
cGMP Compliance

Storage & Handling

Store in original pharmaceutical packaging in a dry, well-ventilated area. Maintain controlled temperature conditions. Protect from moisture and contamination. Non-hygroscopic nature allows for easier handling and storage. Use appropriate material handling equipment and ensure proper documentation for pharmaceutical traceability.

Controlled temperature (15-30°C)
Dry conditions (non-hygroscopic)
Protect from contamination
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Mannitol exhibits unique pharmaceutical properties through its crystalline structure and osmotic activity, enabling precise formulation applications with predictable dissolution, compression, and stability characteristics.

Crystal Polymorphism

Exists in multiple crystalline forms (α, β, δ) with different properties

β-form preferred for tableting applications
Osmotic Activity

Creates osmotic pressure gradients for controlled drug release

Enhances dissolution rate and bioavailability
Hydrogen Bonding

Multiple hydroxyl groups enable extensive hydrogen bonding networks

Contributes to excellent compactibility
Non-Hygroscopic Nature

Low moisture uptake due to stable crystal structure

Maintains tablet integrity under various humidity conditions

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 toxicological and safety 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 Mannitol performance in your pharmaceutical formulations.

Formulation Development
  • Direct compression formulation design
  • Tablet hardness optimization studies
  • Dissolution enhancement strategies
  • Taste masking applications
Analytical Services
  • Particle size distribution analysis
  • Crystal form identification and stability
  • Compactibility profiling
  • Osmotic activity measurement
Technical Support
  • Direct compression troubleshooting
  • Manufacturing scale-up guidance
  • Quality control method development
  • Regulatory documentation support
Supply Solutions
  • Multiple particle size grades available
  • Flexible packaging configurations
  • Just-in-time delivery programs
  • Global excipient distribution network

Environmental Impact & Sustainability

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

Natural Source

Derived from renewable seaweed and plant-based sources

Water Conservation

Advanced crystallization water recycling systems

Energy Efficiency

Optimized crystallization process with heat recovery

Waste Reduction

Crystallization mother liquor recycling programs

ISO 14001

Environmental management system certified production

Carbon Footprint

Optimized logistics and regional distribution strategies

Manufacturing Excellence & Quality Control

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

Production Process

Controlled crystallization in pharmaceutical-grade environment

Precise crystal form control for optimal compaction
Quality Testing

Comprehensive testing including crystal form analysis and compactibility

X-ray diffraction and texture analysis
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 crystal stability and prevents caking

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating Mannitol effectiveness across diverse formulation applications with quantified compression, dissolution, and stability performance metrics.

Direct Compression
Compactibility: Excellent binding properties Flowability: 15-20 seconds Carr index Hardness: 8-12 kP tablet strength
Dissolution Enhancement
Dissolution: 3-5x faster drug release Osmotic Effect: Rapid disintegration Bioavailability: 20-30% improvement
Manufacturing Benefits
Stability: Non-hygroscopic under 75% RH Compatibility: Inert with most APIs Cost-Effectiveness: 25% formulation cost reduction

DRAVYOM Competitive Advantages

Superior Quality

Consistently exceeds USP-NF specifications with optimized crystal form distribution and compaction properties

Reliable Supply

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

Formulation Expertise

Dedicated formulation science team provides direct compression and dissolution optimization guidance

Quality Assurance

Comprehensive certificates with complete analytical data and crystal form 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