Aspartame
Pharmaceutical Premium
Pharmaceutical Excipient

Aspartame

High-purity pharmaceutical Aspartame manufactured to meet stringent USP and EP specifications for sweetening applications. Our Aspartame provides excellent sweetening properties with superior taste profile for various pharmaceutical and oral formulations.

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

Chemical Formula: C14H18N2O5
CAS Number: 22839-47-0
Molecular Weight: 294.30 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White crystalline powder
Water Content (Karl Fischer): ≤4.5%
Residue on Ignition: ≤0.2%
Heavy Metals (as Pb): ≤5 ppm
Related Substances: ≤2.0% total impurities
Storage Conditions: Store in cool, dry place (15-30°C)
Packaging Options: 25kg, 50kg pharmaceutical drums

Applications

Pharmaceutical Sweetening Agent
Oral Formulation Sweetener
Chewable Tablet Applications
Pharmaceutical Excipient
Taste Masking Applications
Pharmaceutical Research
Oral Dosage Form Manufacturing
Quality Control Testing
Regulatory Compliance
Formulation Development
Analytical Method Development
Reference Standard Applications

Industry-Specific Grades

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

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤4.5% Heavy Metals: ≤5 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤2.0% Residue on Ignition: ≤0.2% Application: European market compliance
Food Grade
Purity: ≥98.0% (analytical) Water Content: ≤5.0% Particle Size: Controlled Application: Food and pharmaceutical use
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/g Microbial Limits: Compliant Application: Oral pharmaceutical products

Quality Standards

DRAVYOM's pharmaceutical grade Aspartame 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
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Aspartame exhibits exceptional chemical properties essential for sweetening agent applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Slightly soluble
LogP (octanol/water): -0.6
pKa: 2.7, 8.9
UV λmax: 258 nm (water)
Physical Properties
Melting Point: 246-247°C
Bulk Density: 0.6-0.8 g/mL
Crystalline Form: White crystalline powder
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Sweetness Potency: 200x sucrose
Metabolism: Rapid hydrolysis to amino acids
Caloric Value: 4 kcal/g (negligible use levels)
Taste Profile: Clean, sugar-like sweetness
Purity Specifications
Assay (HPLC): ≥98.0%
Related Substances: ≤1.5% total
Water Content: ≤4.5% (Karl Fischer)
Residue on Ignition: ≤0.2%
Stability Properties
Shelf Life: 3 years (unopened)
Temperature Sensitivity: Store below 25°C
pH Stability Range: 3.0-5.0 (optimal)
Heat Stability: Limited at high temperatures

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Aspartame superiority in sweetening applications with exceptional taste profile, precision, and reproducibility across diverse pharmaceutical and food supplement formulation protocols and research procedures.

Pharmaceutical Performance

Assay: ≥98.0% active sweetening agent

Exceptional purity for pharmaceutical formulations
Sweetening Potency

Intensity: 200x sweeter than sucrose

Superior sweetening efficiency
Dissolution Rate

Solubility: Rapid dissolution characteristics

Enhanced formulation compatibility
Thermal Stability

Working range: Below 25°C storage

Maintains sweetness under proper conditions
Batch Consistency

Variation: ±0.2% between manufacturing batches

Exceptional lot-to-lot reproducibility
Extended Stability

3 years shelf life under recommended conditions

Long-term pharmaceutical grade integrity

Safety Information

Pharmaceutical excipient requiring standard handling procedures. Use appropriate personal protective equipment and follow good pharmaceutical handling practices. Avoid dust inhalation and skin contact. Handle in well-ventilated areas and ensure proper hygiene measures. Contains phenylalanine - contraindicated in phenylketonuria.

Caution Required
PKU Warning
Avoid Inhalation

Storage & Handling

Store in original containers in a cool, dry area (below 25°C) away from moisture and incompatible materials. Keep containers tightly closed and protect from humidity. Use standard pharmaceutical storage protocols and ensure proper material identification and segregation from heat sources.

Cool storage (below 25°C)
Protect from moisture
Away from heat sources
Original packaging recommended

Chemical Mechanisms & Reaction Pathways

Aspartame exhibits artificial sweetening properties through dipeptide methyl ester structure, enabling precise pharmaceutical applications with predictable stability pathways and quantitative sweetness enhancement mechanisms.

Taste Receptor Activation

Selective binding to sweet taste receptors with high potency

Quantitative sweetness enhancement (200x sucrose)
Metabolic Pathway

Hydrolysis to aspartic acid, phenylalanine, and methanol

Essential for pharmaceutical safety assessment
Thermal Sensitivity

Temperature-dependent stability requiring controlled processing

Enables targeted formulation strategies
pH Stability

Optimal stability in slightly acidic pharmaceutical formulations

Predictable formulation compatibility

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonization pharmaceutical compliance

FDA Registration

United States Food and Drug Administration compliance

Method Validation

Supported analytical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize pharmaceutical grade Aspartame performance in your specific therapeutic applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence validation
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • Manufacturing best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical grade Aspartame production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical containers with controlled atmosphere packaging

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating pharmaceutical grade Aspartame effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: Consistent sweetening levels Stability: 36+ months under controlled conditions
Research Institutions
Clinical Studies: 500+ published research applications Reproducibility: >98% batch-to-batch consistency Innovation: Custom grade development
Generic Manufacturing
Regulatory Success: 100% FDA approval support Cost Efficiency: 25% reduction in manufacturing costs Quality Assurance: Zero batch failures

DRAVYOM Competitive Advantages

Superior Purity

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

Reliable Supply

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

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and regulatory compliance support

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services