Sorbitol USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Sorbitol USP/EP

High-purity pharmaceutical grade Sorbitol manufactured under stringent cGMP conditions. This versatile sugar alcohol excipient is essential for pharmaceutical manufacturing, serving as sweetener, filler, and humectant in chewable tablet formulations, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Crystalline and Liquid Forms Available
  • Comprehensive COA Documentation
  • Multi-functional Sugar Alcohol
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C6H14O6
CAS Number: 50-70-4
Molecular Weight: 182.17 g/mol
Physical State: White crystalline powder
Purity: ≥99.5% (USP/EP Grade)
pH (5% solution): 5.0-7.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Chlorides: ≤50 ppm
Sulfates: ≤100 ppm
Solubility: Freely soluble in water
Melting Point: 88-102°C
Storage Conditions: Store at room temperature
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Chewable Tablets
Sweetening Agent
Tablet Filler
Humectant
Pharmaceutical Excipient
Laxative Formulations
Liquid Formulations
Injectable Solutions
Pharmaceutical Research
Oral Care Products
Soft Gel Capsules
USP/EP Applications

Industry-Specific Grades

DRAVYOM offers specialized Sorbitol grades tailored for specific pharmaceutical and food applications, ensuring optimal performance and regulatory compliance across diverse sweetening and excipient applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.5% Heavy Metals: ≤10 ppm Chlorides: ≤50 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.5% pH: 5.0-7.0 (5% solution) Melting Point: 88-102°C Application: EU regulatory submissions
Food Grade
Purity: ≥99.0% Microbiology: Compliant Pesticide Residues: <0.1 ppm Application: Food applications
Injectable Grade
Purity: ≥99.9% Endotoxin: ≤0.5 EU/g Sterility: Compliant Application: Injectable formulations

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.5% Purity
Advanced Purity Testing
Food Grade Compliant
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Pharmaceutical Grade Sorbitol exhibits exceptional chemical properties essential for pharmaceutical applications. Its ultra-pure composition and precise specification ensure reliable performance in demanding pharmaceutical formulations and therapeutic applications.

Pharmaceutical Properties
Sweetness Relative to Sucrose: 0.6 (60% sweetness)
Caloric Value: 2.6 kcal/g
Glycemic Index: 9 (very low)
Hygroscopicity: High (humectant properties)
Physical Properties
Melting Point: 95-97°C
Boiling Point: 295°C (decomposition)
Density (20°C): 1.489 g/cm³
Solubility in Water: 220 g/100 mL (20°C)
Pharmaceutical Performance
Tablet Hardness Enhancement: 15-25% improvement
Dissolution Rate: Rapid (≤15 minutes)
Moisture Retention: Excellent humectant effect
Compatibility: Wide drug compatibility range
Purity Specifications
Total Impurities: ≤ 0.5%
Heavy Metals: ≤ 10 ppm
Chlorides: ≤ 50 ppm
Microbial Count: ≤ 100 CFU/g
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Stable under normal light
Temperature Stability: Stable 15-30°C
Humidity Stability: Stable ≤60% RH

Performance Characteristics

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

Tablet Performance

Hardness: 15-25% improvement over standard excipients

Enhanced mechanical strength for tablets
Dissolution Profile

Release rate: ≥85% in 15 minutes

Rapid bioavailability enhancement
Sweetening Efficacy

Palatability: 60% sucrose equivalent sweetness

Superior taste masking for pediatric formulations
Thermal Stability

Processing range: Stable up to 180°C

Suitable for hot-melt processing
Batch Consistency

Variation: ±0.2% between production batches

Exceptional pharmaceutical grade uniformity
Microbiological Stability

3 years shelf life with maintained specifications

Extended pharmaceutical grade integrity

Safety Information

Generally recognized as safe (GRAS) for pharmaceutical and food applications. Non-toxic excipient with excellent biocompatibility. Handle with standard laboratory precautions including appropriate protective equipment. Avoid inhalation of powder and ensure proper ventilation during processing.

GRAS Status
Biocompatible
Non-Toxic

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 (15-30°C)
Low humidity (≤60% RH)
Original sealed containers
Protect from direct sunlight

Chemical Mechanisms & Reaction Pathways

Pharmaceutical Grade Sorbitol exhibits unique chemical properties through multiple hydroxyl groups enabling versatile pharmaceutical applications with predictable reaction pathways and osmotic effects in drug formulations.

Polyol Chemistry

Six hydroxyl groups provide extensive hydrogen bonding capabilities

Enhanced drug solubility and stability enhancement
Osmotic Properties

Controlled osmotic pressure for pharmaceutical applications

Essential for osmotic drug delivery systems
Complexation

Forms stable complexes with APIs for enhanced formulation

Enables improved drug bioavailability
Stabilization

Prevents crystallization and maintains amorphous forms

Critical for sustained-release 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

GRAS Status

Generally Recognized as Safe for pharmaceutical use

REACH Registration

European Union chemical regulation compliance

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, stability testing assistance, and regulatory services to optimize Pharmaceutical Grade Sorbitol performance in your specific drug formulations.

Formulation Development
  • Drug formulation optimization support
  • Excipient compatibility studies
  • Stability enhancement guidance
  • Custom grade development
Analytical Services
  • Certificate of Analysis verification
  • Custom purity testing
  • Impurity profile analysis
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Regulatory compliance support
  • Manufacturing best practices
Supply Solutions
  • Consistent pharmaceutical-grade supply
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our Pharmaceutical Grade Sorbitol production emphasizes environmental responsibility through sustainable manufacturing practices, renewable feedstock utilization, and comprehensive environmental impact management for pharmaceutical operations.

Sustainable Sourcing

Renewable glucose-based feedstock with minimal environmental impact

Water Conservation

Advanced water recycling and treatment systems

Clean Production

Energy-efficient hydrogenation with emission controls

Waste Minimization

Zero-waste production with by-product recovery

ISO 14001

Environmental management system certified production

Carbon Neutral

Carbon-neutral production with renewable energy

Manufacturing Excellence & Quality Control

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

Production Process

Advanced hydrogenation and crystallization in pharmaceutical-grade environment

Multi-stage purification for pharmaceutical quality
Quality Testing

20-point pharmaceutical testing protocol including microbiological and impurity analysis

HPLC verification and microbiological testing
Quality Systems

cGMP compliance with pharmaceutical manufacturing standards

Continuous improvement and process validation
Packaging Control

Pharmaceutical-grade containers with moisture protection

Contamination prevention and stability maintenance

Market Applications & Performance Data

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

Pharmaceutical Manufacturing
Tablets: 95% dissolution improvement Stability: 24-month shelf life extension Bioavailability: 30% enhancement
Injectable Formulations
Osmolality: Precise control ±2% Compatibility: 100% API stability Sterility: USP <61> compliant
Oral Solutions
Palatability: 90% patient preference Stability: 36-month proven stability Viscosity: Optimized flow properties

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds USP specifications with ultra-low impurities and exceptional pharmaceutical performance

Reliable Supply

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

Formulation Expertise

Dedicated pharmaceutical team provides formulation development and troubleshooting support

Quality Assurance

Traceable certificates with comprehensive pharmaceutical data and regulatory support

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services