Dextrose USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Dextrose USP/EP

High-purity pharmaceutical grade Dextrose manufactured under stringent cGMP conditions. This natural sugar excipient is essential for pharmaceutical manufacturing, serving as sweetener, filler, and energy source in formulations, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Anhydrous and Monohydrate Forms
  • Comprehensive COA Documentation
  • Natural Sugar Excipient
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C6H12O6
CAS Number: 50-99-7
Molecular Weight: 180.16 g/mol
Purity (Assay): ≥99.5% (pharmaceutical grade)
Physical State: White crystalline powder
Water Content (Loss on Drying): ≤0.5% (anhydrous) / ≤8.5% (monohydrate)
Optical Rotation: +52.5° to +53.5°
Heavy Metals (as Pb): ≤5 ppm
pH (5% solution): 4.0-6.5
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 25kg, 50kg pharmaceutical containers

Applications

Pharmaceutical Sweetener Applications
Tablet Filler and Diluent
Injectable Pharmaceutical Products
Energy Source in Formulations
Pharmaceutical Excipient
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Formulation Development
Analytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Dextrose grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse excipient and active ingredient applications.

USP Grade (Pharmaceutical)
Purity: ≥99.5% (Assay) Water Content: ≤0.5% (anhydrous) Heavy Metals: ≤5 ppm Application: Pharmaceutical excipient
EP Grade (European Pharmacopoeia)
Purity: ≥99.5% (pharmaceutical) Optical Rotation: +52.5° to +53.5° pH: 4.0-6.5 Application: European market compliance
Research Grade
Purity: ≥99.0% (analytical) Water Content: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.8% (pharmaceutical) Endotoxins: ≤0.25 EU/g Microbial Limits: Compliant Application: Injectable formulations

Quality Standards

DRAVYOM's pharmaceutical grade Dextrose 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
≥99.5% 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 Dextrose exhibits exceptional chemical properties essential for injectable and nutritional therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Freely soluble
LogP (octanol/water): -3.2
Optical Rotation: +52.5° to +53.0°
Molecular Weight: 180.16 g/mol
Physical Properties
Appearance: White crystalline powder
Melting Point: 146°C
Bulk Density: 0.6-0.8 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: 100% (IV administration)
Metabolism: Glycolysis pathway
Half-life: Rapid metabolic clearance
Function: Energy source, osmotic agent
Purity Specifications
Assay (Polarimetry): ≥99.5%
Related Substances: ≤0.5% total
Water Content: ≤0.5% (Karl Fischer)
Sulfated Ash: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store below 25°C
pH Stability: Stable in neutral solutions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Dextrose superiority in injectable and nutritional applications with exceptional purity, bioavailability, and reproducibility across diverse therapeutic protocols.

Energy Source

4 kcal/g energy content

Rapid cellular energy metabolism
Osmotic Properties

Osmolality: 278 mOsm/L (5% solution)

Ideal for fluid and electrolyte therapy
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 146°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Injectable Grade

Ultra-low endotoxin levels

Safe for parenteral administration

Safety Information

Pharmaceutical grade excipient requiring professional handling. Well-established safety profile for injectable therapy. Handle with pharmaceutical-grade safety precautions and ensure proper GMP environmental controls. Clinical monitoring for glucose levels during therapeutic use.

Pharmaceutical Grade
Professional Use
Monitor glucose levels

Storage & Handling

Store in original containers in a cool, dry, well-ventilated area away from moisture and light. Keep containers tightly closed and maintain pharmaceutical-grade environmental controls. Use appropriate GMP handling techniques for excipient processing.

Cool storage (15-25°C)
Protect from moisture (hygroscopic)
Protect from light
GMP handling required

Chemical Mechanisms & Reaction Pathways

Dextrose exhibits metabolic properties through cellular glucose uptake and glycolysis, enabling predictable energy provision with well-characterized pharmacokinetic and pharmacodynamic profiles.

Mechanism of Action

Cellular glucose uptake and glycolysis pathway

Direct energy provision
Metabolic Pathway

Glycolysis with conversion to pyruvate

Rapid cellular energy production
Pharmacokinetics

Intravenous administration with immediate distribution

Rapid glucose equilibration
Elimination

Complete cellular metabolism to CO2 and H2O

Natural metabolic clearance

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 Dextrose 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 Dextrose 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 Dextrose 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 Dextrose effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Formulations
Bioavailability: 100% IV administration Half-life: Rapid cellular metabolism Stability: 3+ years ambient storage
Clinical Applications
Efficacy: Fluid replacement therapy Safety: Glucose monitoring required Dosage: 5-50% IV solutions
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