Colloidal Silicon Dioxide
Pharmaceutical Premium
Pharmaceutical Excipient

Colloidal Silicon Dioxide

High-purity pharmaceutical Colloidal Silicon Dioxide manufactured to meet stringent USP and EP specifications for pharmaceutical formulation. Our CSD provides excellent glidant and anti-caking properties, ensuring superior powder flowability and processing efficiency.

  • USP/EP Pharmaceutical Grade
  • Superior Glidant Properties
  • Excellent Anti-caking Properties
  • Enhanced Powder Flowability
  • Consistent Quality
  • Ultra-Low Moisture Content
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Technical Specifications

Chemical Formula: SiO2
CAS Number: 7631-86-9
Molecular Weight: 60.08 g/mol
Purity (Assay): ≥99.0% (pharmaceutical grade)
Physical State: White, fine, fluffy powder
Water Content (Loss on Drying): ≤2.5%
Particle Size (D50): 7-15 nm
Heavy Metals (as Pb): ≤10 ppm
pH (10% suspension): 3.5-4.5
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Pharmaceutical Glidant Applications
Anti-caking Agent Formulations
Tablet and Capsule Manufacturing
Powder Flow Enhancement
Pharmaceutical Processing Aid
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Formulation Development
Analytical Method Development
Reference Standard Applications

Industry-Specific Grades

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

USP Grade (Pharmaceutical)
Purity: ≥99.0% (Assay) Water Content: ≤2.5% Heavy Metals: ≤10 ppm Application: Pharmaceutical excipient
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Particle Size: 7-15 nm pH: 3.5-4.5 Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: ≤3.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/g Microbial Limits: Compliant Application: Critical formulations

Quality Standards

DRAVYOM's pharmaceutical grade Colloidal Silicon Dioxide is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% Pharmaceutical Purity
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Colloidal Silicon Dioxide exhibits exceptional chemical properties essential for pharmaceutical excipient applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Practically insoluble
LogP (octanol/water): Not applicable
pKa: Not applicable
UV λmax: Not applicable
Physical Properties
Melting Point: 1600°C
Bulk Density: 0.03-0.15 g/mL
Crystalline Form: White amorphous powder
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: Not absorbed
Protein Binding: Not applicable
Half-life: Not applicable
Elimination: Unchanged excretion
Purity Specifications
Assay (SiO2): ≥99.0%
Heavy Metals: ≤10 ppm
Water Content: ≤7.0% (Karl Fischer)
Loss on Ignition: ≤7.0%
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Not light sensitive
Temperature Stability: Stable 15-30°C
Container Compatibility: HDPE, paper bags

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Colloidal Silicon Dioxide superiority in excipient applications with exceptional anti-caking properties, flowability enhancement, and reproducibility across diverse pharmaceutical formulations and tablet manufacturing protocols.

Anti-caking Properties

Prevents powder agglomeration

Excellent flow enhancement
Tablet Stability

Stable in solid dosage forms

Excellent pharmaceutical stability
Moisture Absorption

Controlled moisture uptake

Consistent desiccant performance
Temperature Stability

Stable under ambient conditions

Consistent performance 15-30°C
Batch Reproducibility

Variation: ±0.3% between batches

Exceptional lot-to-lot consistency
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Handle with standard pharmaceutical safety precautions. Use appropriate personal protective equipment including safety goggles, gloves, and protective clothing. Avoid inhalation of powder and ensure adequate ventilation in work areas. Follow established pharmaceutical handling protocols.

Caution
Avoid Inhalation
Wear Gloves

Storage & Handling

Store in original containers in a cool, dry place protected from moisture. Keep containers tightly closed and maintain pharmaceutical storage conditions. Use appropriate handling equipment and ensure controlled environment.

Store at 15-30°C
Protect from moisture
Keep containers tightly closed
Avoid dust generation

Chemical Mechanisms & Reaction Pathways

Colloidal Silicon Dioxide exhibits excipient properties through surface chemistry interactions, enabling predictable pharmaceutical performance with well-characterized physicochemical behavior.

Mechanism of Action

Surface adsorption and flow enhancement properties

Anti-caking and glidant function
Surface Chemistry

Silanol groups providing hydrophilic surface interactions

Moisture adsorption capacity
Physical Properties

Amorphous structure with high surface area

Nano-scale particle size distribution
Stability

Chemically inert with excellent thermal stability

pH-independent performance

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international drug registration and regulatory submissions.

USP Monograph

United States Pharmacopeia specifications compliance

EP Standards

European Pharmacopoeia monograph requirements

cGMP Manufacturing

Current Good Manufacturing Practices compliance

ICH Guidelines

International Council for Harmonisation standards

DMF Support

Drug Master File documentation assistance

Audit Readiness

Regulatory inspection preparation and support

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory guidance, and technical services to optimize Colloidal Silicon Dioxide performance in your specific pharmaceutical applications.

Formulation Development
  • Excipient compatibility studies
  • Stability testing protocols
  • Dissolution optimization
  • Bioavailability enhancement
Analytical Services
  • Method validation support
  • Impurity identification
  • Stability indicating methods
  • Pharmaceutical testing
Technical Support
  • Regulatory compliance guidance
  • Quality assurance protocols
  • Manufacturing process support
  • Documentation preparation
Supply Solutions
  • Pharmaceutical grade scheduling
  • Global regulatory shipping
  • Custom packaging options
  • Emergency supply protocols

Environmental Impact & Sustainability

Our Colloidal Silicon Dioxide production emphasizes environmental responsibility through sustainable pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Waste Minimization

Optimized synthesis with minimal pharmaceutical waste

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Pharmaceutical waste management guidance

ISO 14001

Environmental management system certification

Green Chemistry

Sustainable pharmaceutical synthesis methods

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Colloidal Silicon Dioxide quality and performance across all production batches.

cGMP Production

Current Good Manufacturing Practices in controlled pharmaceutical environment

FDA and WHO-GMP certified facility
Quality Testing

Comprehensive pharmaceutical testing including identity, purity, and potency

USP/EP monograph compliance verification
Quality Systems

ISO 9001:2015 with pharmaceutical quality management

Continuous improvement and validation
Packaging Control

Pharmaceutical-grade packaging with moisture protection

Stability and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Colloidal Silicon Dioxide effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Formulations
Functionality: Glidant and anti-caking agent Concentration: 0.1-1.0% w/w typical usage Stability: 5+ years ambient storage
Clinical Applications
Efficacy: Improved flow properties Safety: GRAS status excipient Dosage: Variable based on application
Manufacturing Data
Purity: >99.5% pharmaceutical grade Consistency: ±0.3% batch variation Yield: >95% synthesis efficiency

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with exceptional pharmaceutical quality and performance

Reliable Supply

Guaranteed pharmaceutical-grade availability with cGMP production scheduling

Development Expertise

Dedicated pharmaceutical development team providing formulation and regulatory support

Quality Assurance

Comprehensive COA with pharmaceutical testing and regulatory compliance documentation

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom API development