Oxaliplatin API
Pharmaceutical Oncology
Oncology API

Oxaliplatin

High-purity pharmaceutical grade Oxaliplatin 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: C8H14N2O4Pt
CAS Number: 61825-94-3
EINECS Number: 263-236-2
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 397.28 g/mol
Melting Point: Decomposes at 230°C
pH (1% solution): 4.0-6.0
Loss on Drying: ≤1.0%
Residue on Ignition: ≤0.2%
Platinum Content: 48.0-50.0%
Solubility: Soluble in water, methanol
Storage Conditions: Store at 2-8°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1g, 5g, 25g vials

Applications

Colorectal Cancer Therapy
FOLFOX Chemotherapy
Injectable Solutions
DNA Crosslinking Agent
IV Infusion Preparations
Advanced Cancer Treatment
Platinum-based Chemotherapy
Combination Therapies
Oncology Research
Clinical Trials
Cancer Drug Development
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Oxaliplatin grades tailored for specific oncology applications, ensuring optimal chemotherapeutic efficacy and regulatory compliance across diverse cancer treatment formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Platinum Content: 48.0-50.0% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Injectable Grade
Purity: ≥99.5% Sterility: Assured Endotoxins: <0.25 EU/mg Application: IV chemotherapy
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Cancer research

Quality Standards

DRAVYOM's Oxaliplatin is manufactured under stringent cGMP protocols, meeting international oncology drug standards including USP, EP, and FDA guidelines for cancer chemotherapy applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Oncology Efficacy Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Cold Chain Storage & Shipping

Advanced Chemical Properties & Performance

Pharmaceutical Grade Oxaliplatin exhibits exceptional chemical properties essential for oncology applications. Its potent platinum-based structure and superior stability characteristics ensure reliable performance in demanding chemotherapy formulations.

Molecular Properties
Molecular Weight: 397.29 g/mol
Molecular Formula: C8H14N2O4Pt
Platinum Content: 48.0-50.0%
Solubility (Water): 6 mg/mL at 25°C
Physical Properties
Melting Point: 270°C (decomposes)
Appearance: White to off-white crystalline powder
Crystal Form: Anhydrous crystalline
Bulk Density: 0.60-0.70 g/cm³
Pharmaceutical Properties
Protein Binding: 90% (irreversible)
Half-life (α): 0.43 hours
Half-life (β): 16.8 hours
Mechanism: DNA cross-linking and adduct formation
Quality Specifications
Purity (HPLC): ≥99.0%
Water Content: ≤1.0%
Related Substances: ≤1.0%
Heavy Metals: ≤10 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-25°C
Light Sensitivity: Store in light-resistant containers
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate Oxaliplatin superiority in oncology applications with exceptional DNA cross-linking activity, colorectal cancer efficacy, and therapeutic performance across diverse chemotherapy treatment protocols.

DNA Cross-linking

Formation of platinum-DNA adducts

Potent cytotoxic activity
Cell Cycle Arrest

G2/M phase cell cycle blockade

Enhanced tumor cell death
Colorectal Efficacy

Superior activity in colorectal cancer

First-line chemotherapy agent
Resistance Profile

Activity against cisplatin-resistant tumors

Overcoming platinum resistance
Clinical Performance

FDA-approved for colorectal cancer

Proven oncological efficacy
Injectable Stability

Stable in aqueous formulations

Reliable IV administration

Safety Information

Highly potent cytotoxic pharmaceutical active ingredient requiring specialized handling protocols. Handle in controlled environments with appropriate containment systems. Use proper personal protective equipment and follow established safety protocols for chemotherapy agents.

Highly Cytotoxic
Hazardous Drug
Containment Required

Storage & Handling

Store in tightly closed, light-resistant containers in a cool, dry place away from direct sunlight. Maintain controlled room temperature storage in secure, specialized chemotherapy storage areas with appropriate containment systems and access controls.

Controlled room temperature (15-25°C)
Secure containment required
Light-resistant containers
Hazardous drug protocols

Chemical Mechanisms & Reaction Pathways

Oxaliplatin demonstrates potent antineoplastic activity through DNA cross-linking and platinum-DNA adduct formation, providing effective cancer treatment with distinctive mechanisms compared to other platinum compounds.

DNA Cross-linking

Formation of platinum-DNA adducts blocking replication

Cytotoxic activity against cancer cells
Unique Ligand

Diaminocyclohexane ligand provides distinct activity

Overcomes cisplatin resistance
Cell Cycle Arrest

Induction of apoptosis through DNA damage

Multi-phase cell cycle inhibition
Pharmacokinetic Profile

Intravenous administration with rapid distribution

Targeted cancer therapy delivery

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical acceptance with complete documentation packages supporting international drug development and manufacturing requirements.

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Oxaliplatin performance in pharmaceutical applications.

Formulation Development
  • Injectable formulation development
  • Stability enhancement strategies
  • Lyophilization optimization
  • Compatibility studies
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Platinum content analysis
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Cold chain packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Oxaliplatin production emphasizes environmental responsibility through sustainable pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

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

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, ICP-MS, and platinum analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with light protection

Stability maintenance and protection systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Oxaliplatin effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Stability: Controlled storage conditions Potency: Consistent anticancer activity
Drug Development
Formulation Support: Injectable oncology products Regulatory Success: Global approvals achieved Innovation: Combination therapy development
Clinical Applications
Efficacy: Proven anticancer activity Safety: Established safety profile Specialization: Colorectal cancer treatment

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services