Sucralose
Pharmaceutical Premium
Pharmaceutical Excipient

Sucralose

High-purity pharmaceutical Sucralose manufactured to meet stringent USP and EP specifications for sweetening applications. Our Sucralose provides excellent sweetening properties with superior stability and enhanced solubility for various pharmaceutical formulations.

  • USP/EP Pharmaceutical Grade
  • Superior Sweetening Properties
  • Excellent Stability
  • Enhanced Solubility
  • Consistent Quality
  • Ultra-Low Impurities
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Technical Specifications

Chemical Formula: C12H19Cl3O8
CAS Number: 56038-13-2
Molecular Weight: 397.64 g/mol
Physical State: White crystalline powder
Purity: ≥98.0% (USP/EP Grade)
Loss on Drying: ≤2.0%
Residue on Ignition: ≤0.7%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Particle Size: D90 ≤ 200 μm
pH (1% solution): 5.0-7.0
Solubility: Freely soluble in water
Storage Conditions: Store at room temperature, dry place
Shelf Life: 5 years from date of manufacture
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Pharmaceutical Sweetener
Chewable Tablets
Oral Solutions
Oral Suspensions
Pediatric Formulations
Oral Drops
Syrup Formulations
Taste Masking
Diabetic Formulations
OTC Medications
Sugar-Free Formulations
USP/EP Applications

Industry-Specific Grades

DRAVYOM offers specialized Sucralose grades tailored for specific pharmaceutical sweetening applications, ensuring optimal performance and regulatory compliance across diverse taste masking and palatability enhancement requirements.

USP Grade (United States Pharmacopeia)
Purity: ≥98.0% Heavy Metals: ≤10 ppm Related Substances: ≤1.0% Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% Loss on Drying: ≤2.0% pH: 5.0-7.0 (1% solution) Application: EU regulatory submissions
Sweetener Grade
Purity: ≥99.0% Sweetness Profile: Verified Stability: Enhanced Application: Pharmaceutical sweetening
Pediatric Grade
Purity: ≥99.5% Palatability: Optimized Safety Profile: Verified Application: Pediatric formulations

Quality Standards

DRAVYOM's Sucralose is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP specifications. Our sweetener-grade production ensures consistent performance and regulatory compliance.

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥98.0% Purity
Advanced Sweetness Testing
Sweetening Profile Verified
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Sucralose exhibits exceptional chemical properties essential for pharmaceutical applications. Its chlorinated sucrose composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and sweetening applications.

Chemical Properties
Molecular Formula: C₁₂H₁₉Cl₃O₈
Molecular Weight: 397.64 g/mol
Sweetness Intensity: 600 times sweeter than sucrose
Caloric Value: 0 kcal/g (non-metabolizable)
Physical Properties
Melting Point: 125-130°C
pH (1% solution): 5.0-7.0
Solubility in Water: 28.3 g/100 mL (20°C)
Optical Rotation: +84.3° to +87.7°
Pharmaceutical Performance
Taste Masking Efficiency: Excellent bitter drug masking
Tablet Binding: Compatible with standard binders
Dissolution Impact: No interference with drug release
Stability in Formulations: Stable across pH range
Purity Specifications
Sucralose Content: ≥ 98.0%
Related Compounds: ≤ 2.0%
Heavy Metals: ≤ 10 ppm
Residual Solvents: Within ICH limits
Stability Properties
Shelf Life: 5 years (unopened)
pH Stability: Stable pH 2-10
Temperature Stability: Stable up to 180°C
Light Stability: Stable under normal light

Performance Characteristics

Detailed performance metrics demonstrate Pharmaceutical Grade Sucralose superiority in sweetening applications with exceptional functionality, stability, and reproducibility across diverse pharmaceutical procedures and therapeutic protocols.

Sweetening Performance

Intensity: 600 times sweeter than sucrose

Ultra-low dosage requirements
Taste Masking

Efficiency: Excellent bitter drug masking capability

Enhanced patient compliance
Thermal Stability

Range: Stable up to 180°C processing

Suitable for hot manufacturing processes
pH Stability

Range: Stable from pH 2-10

Wide formulation compatibility
Batch Consistency

Variation: ±0.5% between production batches

Exceptional pharmaceutical grade uniformity
Long-term Stability

5 years shelf life with maintained sweetness

Extended pharmaceutical grade integrity

Safety Information

FDA approved artificial sweetener with excellent safety profile. Non-caloric, non-cariogenic, and suitable for diabetics. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

FDA Approved
Diabetic Safe
Non-Cariogenic

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from moisture and direct sunlight. Use appropriate pharmaceutical handling procedures and ensure proper environmental controls for humidity management.

Cool storage (15-25°C)
Low humidity (≤60% RH)
Original sealed containers
Protect from direct sunlight

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Sucralose exhibits unique organohalogen properties through selective chlorination enabling versatile pharmaceutical applications with predictable sweetening mechanisms and exceptional stability in drug formulations.

Sweetening Mechanism

Selective binding to taste receptors without metabolic activation

Non-caloric sweetening for diabetic formulations
Chemical Stability

Resistant to hydrolysis and thermal degradation

Maintains potency throughout shelf life
Non-Metabolizable

Passes through body unchanged without caloric contribution

Safe for diabetic and weight management products
pH Stability

Maintains stability across wide pH range (2-10)

Compatible with various pharmaceutical formulations

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical market access with complete documentation packages supporting international standards and pharmaceutical manufacturing validations.

USP Specifications

United States Pharmacopeia pharmaceutical excipient standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical applications

FDA Approved

FDA approved artificial sweetener for pharmaceutical use

EFSA Approved

European Food Safety Authority approval for pharmaceutical applications

DMF Support

Drug Master File documentation for regulatory submissions

cGMP Certified

Current Good Manufacturing Practice compliance

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, palatability optimization assistance, and regulatory services to optimize Pharmaceutical Grade Sucralose performance in your specific drug formulations.

Formulation Development
  • Palatability enhancement support
  • Liquid formulation guidance
  • Stability optimization studies
  • Custom sweetening solutions
Analytical Services
  • Certificate of Analysis verification
  • Purity and potency testing
  • Stability studies
  • Sensory evaluation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Dosage optimization guidance
  • Regulatory compliance support
  • Manufacturing best practices
Supply Solutions
  • Consistent pharmaceutical-grade supply
  • Specialized packaging options
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Sucralose production emphasizes environmental responsibility through sustainable sucrose sourcing, energy-efficient processing, and comprehensive environmental impact management for pharmaceutical operations.

Sustainable Sourcing

Renewable sucrose-based feedstock with sustainable agricultural practices

Process Efficiency

Optimized chlorination with minimal waste generation

Clean Production

Advanced separation technology with emission controls

Water Treatment

Advanced wastewater treatment and recycling systems

ISO 14001

Environmental management system certified production

Safe Disposal

Environmentally responsible waste management protocols

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical sweetener manufacturing facility employs advanced purification technology and continuous monitoring systems to ensure consistent Pharmaceutical Grade Sucralose quality and performance across all production batches.

Production Process

Advanced selective chlorination and crystallization in pharmaceutical-grade environment

Multi-stage purification for pharmaceutical purity
Quality Testing

22-point pharmaceutical testing protocol including potency and impurity analysis

HPLC verification and sensory evaluation
Quality Systems

cGMP compliance with pharmaceutical sweetener standards

Continuous improvement and process validation
Packaging Control

Moisture-barrier packaging with light protection

Stability maintenance and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical formulation data demonstrating Pharmaceutical Grade Sucralose effectiveness across diverse applications with quantified performance metrics and palatability validations.

Liquid Formulations
Sweetness: 600x sugar potency Stability: 24-month proven stability Palatability: 95% patient acceptance
Chewable Tablets
Masking: Excellent bitter taste masking Uniformity: Consistent sweetness distribution Processing: Heat-stable during compression
Pediatric Formulations
Safety: Zero caloric contribution Compliance: 90% improved adherence Dosing: Accurate low-dose applications

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds USP specifications with ultra-high purity and exceptional sweetening performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Formulation Expertise

Dedicated pharmaceutical team provides palatability optimization and formulation support

Quality Assurance

Comprehensive testing with pharmaceutical documentation and regulatory support

Global Standards

International compliance with USP, EP, and FDA specifications for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services