Melphalan API
Pharmaceutical Oncology
Oncology API

Melphalan

High-purity pharmaceutical grade Melphalan API manufactured to meet stringent USP/EP specifications for cancer chemotherapy formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical oncology drug manufacturing applications.

  • USP/EP Grade Quality Standards
  • High Purity ≥99.0% (HPLC)
  • Comprehensive Analytical Documentation
  • Regulatory Compliance Support
  • cGMP Manufacturing Standards
  • Pharmaceutical Grade Packaging
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Technical Specifications

Chemical Formula: C13H18Cl2N2O2
CAS Number: 148-82-3
EINECS Number: 205-726-6
Molecular Weight: 305.20 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
Melting Point: 180-182°C
pH (1% solution): 3.0-4.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 100g, 500g, 1kg pharmaceutical containers

Applications

Injectable Chemotherapy
Oral Tablet Formulations
IV Infusion Solutions
Multiple Myeloma Treatment
Oncology Research
Hospital Oncology Units
Specialty Pharmaceutical Manufacturing
Prescription Oncology Drugs
Cancer Research Studies
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Melphalan grades tailored for specific oncology pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse cancer drug manufacturing applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA-compliant oncology formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) Impurities: Individual ≤0.5% Loss on Drying: ≤0.5% Application: EU regulatory submissions
Oncology Research Grade
Purity: ≥99.5% (HPLC) Water Content: ≤0.2% Residue on Ignition: ≤0.05% Application: Cancer research studies
Reference Standard Grade
Purity: ≥99.8% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

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

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Ultra-Low Impurity Levels
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Melphalan exhibits exceptional pharmaceutical properties essential for chemotherapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and cancer treatment protocols.

Pharmaceutical Properties
Molecular Weight: 305.20 g/mol
Solubility (Water): Sparingly soluble
Partition Coefficient: LogP = -0.5
Bioavailability: Variable, dose-dependent
Physical Properties
Melting Point: 180-182°C
Appearance: White to off-white powder
Crystalline Form: Stable polymorphic form
Bulk Density: 0.30-0.50 g/mL
Formulation Performance
Dissolution Rate: ≥80% in 30 minutes
Tablet Hardness: 3-6 kp compatible
Compressibility: Good with proper excipients
Flow Properties: Fair to good
Purity Specifications
Total Impurities: ≤1.0%
Related Substances: ≤0.5% individual
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store 2-8°C
Humidity Sensitivity: Store below 60% RH

Performance Characteristics

Detailed performance metrics demonstrate Melphalan superiority in pharmaceutical applications with exceptional efficacy, stability, and reproducibility across diverse formulation types and therapeutic protocols.

Therapeutic Performance

Bioavailability: Variable, dose-dependent

Excellent antineoplastic efficacy
Dissolution Rate

Release: ≥80% in 30 minutes

Consistent drug release profile
Analytical Performance

Purity: ≥99.0% HPLC

Superior analytical precision
Stability Performance

Shelf life: 3 years under refrigeration

Extended pharmaceutical integrity
Batch Reproducibility

Variation: ±1.0% between batches

Exceptional lot-to-lot consistency
Processing Performance

Compressibility: Good with proper excipients

Superior manufacturing efficiency

Safety Information

HAZARDOUS: Cytotoxic pharmaceutical material requiring specialized handling procedures. Use containment protocols, protective equipment, and trained personnel experienced with cytotoxic agents. Follow all applicable regulatory guidelines for cytotoxic pharmaceutical manufacturing and handling.

Cytotoxic Material
Specialized Containment Required
cGMP Compliance

Storage & Handling

Store in original pharmaceutical packaging under refrigerated conditions (2-8°C). Maintain strict temperature control and protect from light and moisture. Use specialized cytotoxic handling equipment and ensure proper documentation for pharmaceutical traceability and regulatory compliance.

Refrigerated storage (2-8°C)
Protect from light
Cytotoxic containment protocols
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Melphalan exhibits potent antineoplastic activity through DNA cross-linking mechanisms and alkylation pathways, enabling precise oncological applications with selective cellular targeting for cancer treatment protocols.

DNA Alkylation

Bifunctional alkylating agent forming DNA interstrand cross-links

Prevents DNA replication in rapidly dividing cells
Cell Cycle Disruption

Non-cell cycle specific mechanism affecting all phases

Broad spectrum antineoplastic activity
Protein Cross-linking

Secondary protein alkylation contributing to cytotoxicity

Multiple mechanisms of action
Hydrolysis Activation

Hydrolytic activation to reactive intermediates

pH-dependent activation kinetics

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia oncology pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for cytotoxic pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified cytotoxic production facility

ICH Guidelines

International Conference on Harmonisation oncology quality standards

DMF Support

Drug Master File documentation for oncology regulatory submissions

Safety Documentation

Complete cytotoxic safety and handling documentation package

Technical Support & Value-Added Services

DRAVYOM's oncology pharmaceutical development team provides comprehensive formulation support, cytotoxic handling guidance, and regulatory support to optimize Melphalan performance in your oncology pharmaceutical applications.

Formulation Development
  • Injectable formulation optimization
  • Stability enhancement strategies
  • Bioavailability optimization guidance
  • Lyophilization process development
Analytical Services
  • Certificate of Analysis verification
  • Cytotoxic impurity profiling
  • Stability method validation
  • Specialized testing programs
Technical Support
  • Cytotoxic handling consultation
  • cGMP compliance for oncology APIs
  • Containment system design
  • Regulatory documentation support
Supply Solutions
  • Specialized cytotoxic packaging
  • Cold chain logistics
  • Emergency oncology supply
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Melphalan production emphasizes environmental responsibility through sustainable cytotoxic pharmaceutical manufacturing practices, specialized waste management, and comprehensive environmental impact control for oncology operations.

Cytotoxic Waste Management

Specialized treatment and disposal of cytotoxic pharmaceutical waste

Wastewater Treatment

Advanced cytotoxic pharmaceutical wastewater treatment systems

Containment Systems

Closed-loop manufacturing with environmental protection

Resource Recovery

Solvent recovery and raw material optimization programs

ISO 14001

Environmental management system for cytotoxic production

Safe Transport

Specialized logistics minimizing environmental impact

Manufacturing Excellence & Quality Control

DRAVYOM's specialized cytotoxic pharmaceutical manufacturing facility employs advanced containment technology and continuous monitoring systems to ensure consistent Melphalan quality and safety across all production batches.

Production Process

Contained synthesis and purification in specialized cytotoxic environment

Multi-barrier containment for operator and environmental protection
Quality Testing

Comprehensive analytical testing including cytotoxic impurity analysis

Specialized HPLC and mass spectrometry analysis
Quality Systems

ISO 9001:2015 with cytotoxic pharmaceutical manufacturing certification

Specialized quality systems for oncology APIs
Packaging Control

Specialized cytotoxic packaging with environmental protection

Refrigerated storage and controlled atmosphere packaging

Market Applications & Performance Data

Comprehensive oncology pharmaceutical development data demonstrating Melphalan effectiveness across diverse therapeutic applications with quantified performance metrics and clinical development validations for cancer treatment.

Oncology Manufacturing
Bioavailability: Variable, dose-dependent Stability: Refrigerated storage required Purity: >99.0% pharmaceutical grade
Clinical Applications
Efficacy: Proven multiple myeloma treatment Safety: Established toxicity profile Regulatory: Oncology approvals worldwide
Manufacturing Capabilities
Capacity: Controlled production batches Consistency: <0.5% batch-to-batch variation Compliance: 100% cytotoxic cGMP adherence

DRAVYOM Competitive Advantages

Cytotoxic Expertise

Specialized cytotoxic manufacturing with ultra-low impurities and exceptional oncology pharmaceutical performance

Reliable Supply

Guaranteed availability with specialized inventory management and oncology-grade production scheduling

Oncology Expertise

Dedicated oncology pharmaceutical development team with cytotoxic formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and cytotoxic handling documentation

Global Standards

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

Partnership Approach

Collaborative relationships with oncology pharmaceutical companies and custom cytotoxic API development