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 material exhibits reliable properties suitable for pharmaceutical formulations and quality manufacturing. Its consistent composition ensures predictable performance in drug development and production environments.

Basic Properties
Pharmaceutical Grade: USP/EP compliant material
Functionality: Excipient performance properties
Compatibility: Compatible with active ingredients
Stability: Stable under pharmaceutical conditions
Physical Properties
Physical Form: Powder or granular material
Particle Size: Controlled particle distribution
Bulk Density: Optimized for processing
Flow Properties: Good flow characteristics
Pharmaceutical Performance
Formulation Suitability: Excellent for drug formulations
Processing: Suitable for various processes
Dissolution: Predictable dissolution behavior
Bioavailability: Does not affect drug bioavailability
Quality Standards
Purity: ≥99.0% pharmaceutical grade
Heavy Metals: ≤10 ppm
Microbial Limits: USP/EP compliant
Residual Solvents: Within ICH Q3C limits
Stability Properties
Shelf Life: 5 years (unopened)
Storage Stability: Stable under controlled conditions
Retest Period: As per pharmacopeial standards
Container Closure: Pharmaceutical grade packaging

Performance Characteristics

Performance metrics demonstrate pharmaceutical grade reliability in drug formulation and manufacturing applications with consistent quality, regulatory compliance, and optimal performance for pharmaceutical processes.

Formulation Performance

Efficiency: Consistent excipient functionality

Excellent for drug formulations
Regulatory Compliance

Standards: USP/EP/BP pharmacopeial compliance

Meets regulatory requirements
Manufacturing Use

Reliability: Consistent performance in production

Suitable for pharmaceutical manufacturing
Quality Assurance

Validation: Comprehensive quality testing

Validated pharmaceutical material
Batch Consistency

Variation: ±1% between batches

Superior batch-to-batch consistency
Shelf Life

Duration: 5 years under proper storage

Extended stability for pharmaceutical use

Safety Information

Generally safe for pharmaceutical use when handled according to Good Manufacturing Practices. Use appropriate protective equipment including gloves and safety goggles during handling. Follow pharmaceutical handling protocols and maintain clean room standards where applicable.

Pharmaceutical Safe
GMP Handling
Regulatory Approved

Storage & Handling

Store in original pharmaceutical packaging in a controlled environment as per ICH guidelines. Maintain appropriate temperature and humidity conditions. Use pharmaceutical storage equipment and follow Good Distribution Practices for inventory management.

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

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