Lactose Monohydrate (Pharma Grade) - Pharmaceutical Ingredient
Pharmaceutical Filler
Pharmaceutical Ingredient

Lactose Monohydrate (Pharma Grade)

Premium pharmaceutical-grade lactose monohydrate engineered for demanding drug formulation applications including tablet filling, direct compression, and drug dilution. Our high-performance excipient delivers exceptional flow properties, consistent performance, and reliable supply for critical pharmaceutical manufacturing processes requiring superior tablet properties with stringent regulatory compliance standards.

  • USP/EP/IP Grade Compliance
  • 99.0-102.0% Assay
  • 4.5-5.5% Loss on Drying
  • Superior Flow Properties
  • Direct Compression Compatible
  • Pharmaceutical Grade Quality
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Technical Specifications

Chemical Name: Lactose Monohydrate (Pharma Grade)
CAS Number: 64044-51-5
Chemical Formula: C₁₂H₂₂O₁₁·H₂O
Purity (Assay): ≥ 99.0% (Pharma Grade)
Physical State: White crystalline powder
Molecular Weight: 360.31 g/mol
Loss on Drying: 4.5-5.5%
Residue on Ignition: ≤ 0.1%
Heavy Metals (as Pb): ≤ 5 ppm
Protein: ≤ 0.3%
pH (10% solution): 4.0-6.5
Particle Size: D50: 60-200 μm
Microbial Limits: ≤ 1000 CFU/g
Shelf Life: 5 years
Packaging Options: 25kg bags, 500kg drums

Applications

Tablet Filler & Binder
Capsule Diluent
Direct Compression
Dry Powder Inhalers
Infant Formulations
Lyophilization Aid

Industry-Specific Grades

DRAVYOM offers specialized lactose grades tailored for different pharmaceutical formulation requirements, ensuring optimal performance and regulatory compliance.

Direct Compression Grade
Flowability: Excellent Compressibility: High Particle Size: Optimized Application: Tablet manufacturing
Inhalation Grade
Fine Particle: Controlled Aerodynamic: Optimized Endotoxin: ≤ 20 EU/g Application: DPI formulations
Infant Formula Grade
Protein: ≤ 0.15% Instantization: Available Food Safety: Certified Application: Baby nutrition
Standard Grade
USP/EP/IP: Compliant Cost Effective: Optimized Versatile: Multi-purpose Application: General formulations

Quality Standards

DRAVYOM's Lactose Monohydrate is manufactured under cGMP conditions, meeting international pharmaceutical standards for drug formulation applications.

cGMP Certified Manufacturing
Pharmaceutical Grade Standards
≥ 99.0% Lactose Purity
USP/EP/IP Compliant
Complete Microbial Testing
Safe for Infant Use
Certificate of Analysis
Pharmaceutical Support

Advanced Chemical Properties & Performance

Pharmaceutical Grade Lactose Monohydrate exhibits exceptional chemical properties essential for pharmaceutical applications. Its disaccharide structure and precise crystalline form ensure reliable performance in demanding drug formulation and processing applications.

Chemical Properties
Molecular Weight: 360.31 g/mol
Solubility (Water, 25°C): 21.6 g/100 mL
Reducing Power: Positive (reducing sugar)
Optical Rotation: [α]D²⁰ = +55.4°
Physical Properties
Melting Point: 202-205°C
Bulk Density: 0.50-0.65 g/cm³
True Density: 1.54 g/cm³
Particle Size: 20-250 μm (typical)
Pharmaceutical Performance
Lactose Purity: ≥ 99.0% by HPLC
Water Content: 4.5-5.5%
pH (10% solution): 4.0-6.5
Compressibility: Excellent direct compression
Purity Specifications
Protein: ≤ 0.25%
Ash: ≤ 0.10%
Heavy Metals: ≤ 5 ppm
Microbial Count: ≤ 1000 CFU/g
Stability Properties
Shelf Life: 5 years (unopened)
Hygroscopicity: Low moisture uptake
Temperature Stability: Stable up to 145°C
Container Compatibility: HDPE, PP, fiber drums

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Lactose Monohydrate superiority in drug formulation applications with exceptional compressibility, stability, and reproducibility across diverse pharmaceutical processing operations.

Tablet Performance

Compressibility: Excellent direct compression

Superior tablet hardness
Dissolution Performance

Dissolution rate: 95% in 30 minutes

Enhanced drug release
Flow Properties

Angle of repose: 30-40°

Excellent flowability
Thermal Stability

Stable up to 145°C

Process stability assured
Batch Reproducibility

Variation: ± 0.5% between batches

Consistent pharmaceutical quality
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical integrity

Safety Information

Generally recognized as safe (GRAS) pharmaceutical excipient. May cause mild respiratory irritation in dust form. Handle with appropriate protective equipment including dust masks and safety goggles. Ensure adequate ventilation in work areas to prevent dust accumulation.

GRAS Status
Dust Inhalation
Infant Safe

Storage & Handling

Store in original containers in a cool, dry place away from direct sunlight and moisture. Keep containers tightly closed to prevent moisture absorption and contamination. Use pharmaceutical-grade storage equipment and maintain cGMP conditions.

Cool storage (15-25°C)
Protect from moisture
cGMP conditions
Dry, well-ventilated area

Chemical Mechanisms & Reaction Pathways

Lactose monohydrate exhibits excellent compaction properties and chemical stability through hydrogen bonding and crystalline structure, enabling optimal tablet formulation and pharmaceutical processing with predictable performance.

Compaction Mechanism

Plastic deformation and fragmentation during tablet compression processes

Essential for direct compression applications
Crystal Stability

Stable monohydrate crystalline form with predictable processing behavior

Critical for tablet hardness and stability
Flow Properties

Excellent powder flow characteristics for pharmaceutical processing

Enables efficient tablet manufacturing
Chemical Inertness

Non-reactive excipient compatible with diverse pharmaceutical compounds

Important for drug stability and compatibility

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures pharmaceutical-grade lactose monohydrate 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 lactose monohydrate applications in pharmaceutical manufacturing.

Formulation Support
  • Direct compression optimization
  • Tablet hardness improvement
  • Blend uniformity assessment
  • Capsule fill formulation
Technical Services
  • Particle size optimization
  • Flow property enhancement
  • 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 lactose monohydrate production emphasizes environmental responsibility through sustainable dairy sourcing, energy-efficient processing, and comprehensive environmental impact management for sustainable pharmaceutical development.

Sustainable Sourcing

Renewable lactose sources with sustainable dairy practices

Green Processing

Energy-efficient crystallization and purification processes

Clean Production

Low-impact 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 lactose monohydrate manufacturing facility employs advanced crystallization technology and quality systems to ensure consistent pharmaceutical-grade quality and performance across all production batches.

Advanced Crystallization

Controlled crystallization and purification technology for consistent quality

Optimal particle size and crystal form control
Quality Testing

Comprehensive testing including particle size, flow properties, and pharmaceutical specifications

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 lactose monohydrate effectiveness across tablet manufacturing applications with validated performance metrics and pharmaceutical industry adoption for direct compression.

Tablet Manufacturing
Compressibility: 98% tablet hardness target achievement Performance: Consistent compression properties Customer Satisfaction: 95% pharmaceutical approval
Capsule Applications
Fill Properties: Superior powder flow characteristics Content Uniformity: 99.5% blend uniformity achievement Process Efficiency: 25% fill time reduction
Direct Compression
Process Reliability: 99% batch success rate Cost Effectiveness: 20% formulation cost savings Market Share: 60% direct compression segment

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

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

Processing Innovation

Advanced crystallization technology with custom particle size grades and flow 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