Docetaxel Trihydrate API
Pharmaceutical Oncology
Oncology API

Docetaxel Trihydrate

High-purity pharmaceutical grade Docetaxel Trihydrate 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
Request Quote Technical Support

Technical Specifications

Chemical Formula: C43H53NO14·3H2O
CAS Number: 148408-66-6
Molecular Weight: 861.93 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): 5.5-7.0%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store in refrigerator (2-8°C)
Packaging Options: 100g, 500g pharmaceutical containers

Applications

Cancer Chemotherapy Manufacturing
Breast Cancer Treatment
Injectable Oncology Products
API Synthesis & Development
Antimicrotubule Agent Research
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

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

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: 5.5-7.0% Heavy Metals: ≤10 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (pharmaceutical) Related Substances: ≤1.0% Residue on Ignition: ≤0.1% Application: European market compliance
Research Grade
Purity: ≥98.0% (analytical) Water Content: 5.0-8.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤0.25 EU/mg Microbial Limits: Compliant Application: Injectable oncology formulations

Quality Standards

DRAVYOM's pharmaceutical grade Docetaxel Trihydrate 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
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Docetaxel Trihydrate exhibits exceptional chemical properties essential for oncology therapy applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and research applications.

Analytical Properties
Solubility (Water): Practically insoluble
LogP (octanol/water): 3.5
pKa: Non-ionizable
Molecular Weight: 861.93 g/mol
Physical Properties
Appearance: White to off-white powder
Melting Point: 232-234°C
Bulk Density: 0.3-0.5 g/mL
Hygroscopicity: Hygroscopic
Pharmaceutical Performance
Bioavailability: IV administration only
Protein Binding: 95%
Half-life: 11-13 hours
Mechanism: Microtubule stabilizer
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤0.5% total
Water Content: 5.0-7.0% (trihydrate)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store at 2-8°C
pH Stability: Stable in neutral conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Docetaxel Trihydrate superiority in oncology applications with exceptional anti-cancer activity, microtubule stabilization, and reproducibility across diverse therapeutic protocols.

Anti-cancer Activity

Potent microtubule stabilizer

Inhibits cancer cell division
Cytotoxic Efficacy

Broad spectrum anti-tumor activity

Effective against solid tumors
Stability Profile

Chemical stability: Excellent under storage conditions

Maintains potency for 3 years
Thermal Stability

Melting point: 232-234°C

Stable during pharmaceutical processing
Batch Reproducibility

Variation: ±0.1% between batches

Consistent therapeutic efficacy
Cold Storage

Refrigerated storage requirement

Maintained stability at 2-8°C

Safety Information

Cytotoxic pharmaceutical ingredient requiring specialized handling protocols. Well-established safety profile for oncology therapy. Handle with extreme caution using appropriate cytotoxic safety precautions and ensure proper GMP environmental controls. Clinical monitoring for neutropenia and hypersensitivity reactions.

Cytotoxic
Professional Use
Specialized handling

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 cytotoxic handling techniques for API processing.

Refrigerated storage (2-8°C)
Protect from moisture (hygroscopic)
Protect from light
Cytotoxic handling required

Chemical Mechanisms & Reaction Pathways

Docetaxel Trihydrate exhibits cytotoxic and antineoplastic properties through microtubule stabilization and cell cycle arrest mechanisms, promoting cancer cell apoptosis through multiple cellular pathways.

Microtubule Stabilization

Binds to β-tubulin and prevents microtubule depolymerization

Arrests cell division in M-phase
Cell Cycle Arrest

Induces G2/M phase arrest and mitotic catastrophe

Prevents cancer cell proliferation
Apoptosis Induction

Triggers programmed cell death pathways in cancer cells

Selective cytotoxic action
Antiangiogenic Effects

Inhibits tumor blood vessel formation

Reduces tumor growth and metastasis

Regulatory Compliance & Documentation

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

USP Standards

United States Pharmacopeia oncology drug specifications compliance

EP Monograph

European Pharmacopoeia specifications for cytotoxic agents

Cytotoxic GMP

Specialized GMP compliance for cytotoxic drug manufacturing

ICH Guidelines

International oncology drug development regulatory compliance

Oncology DMF

Specialized Drug Master File for oncology applications

Cytotoxic Safety

Comprehensive cytotoxic handling and safety documentation

Technical Support & Value-Added Services

DRAVYOM's oncology pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Docetaxel Trihydrate oncology applications.

Oncology Formulation
  • Cytotoxic formulation optimization
  • Stability testing for oncology drugs
  • Bioavailability enhancement
  • Custom oncology development
Oncology Analytics
  • Cytotoxic API purity analysis
  • Oncology impurity profiling
  • Specialized testing services
  • Oncology method validation
Regulatory Support
  • Oncology regulatory filing
  • Cytotoxic DMF preparation
  • International compliance guidance
  • Oncology pharmacovigilance
Specialized Supply
  • Cytotoxic supply chain management
  • Specialized packaging solutions
  • Cold chain distribution
  • Emergency oncology supply

Environmental Impact & Sustainability

Our Docetaxel Trihydrate production emphasizes environmental responsibility through sustainable cytotoxic manufacturing practices, specialized waste management, and environmental impact control.

Specialized Waste

Cytotoxic waste treatment and disposal protocols

Water Treatment

Advanced wastewater treatment for cytotoxic manufacturing

Clean Production

Contained manufacturing processes with emission controls

Environmental Safety

Comprehensive environmental protection protocols

ISO 14001

Environmental management for pharmaceutical manufacturing

Sustainable Sourcing

Responsible procurement of raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's specialized cytotoxic manufacturing facility employs advanced containment technology and continuous monitoring systems to ensure consistent Docetaxel Trihydrate quality and safety.

Cytotoxic GMP

Specialized containment manufacturing in controlled environment

Multi-stage purification with cytotoxic safety
Oncology Testing

Comprehensive testing including potency, purity, and safety

HPLC and specialized oncology analytics
Quality Systems

ISO 9001:2015 with specialized cytotoxic protocols

Continuous improvement and oncology validation
Specialized Packaging

Cytotoxic-grade containers with refrigeration requirements

Cold chain and contamination prevention

Market Applications & Performance Data

Comprehensive oncology data demonstrating Docetaxel Trihydrate effectiveness in cancer treatment with quantified performance metrics and clinical validation data.

Oncology Formulations
Bioavailability: 95-98% IV administration Stability: 2-year refrigerated shelf life Potency: Consistent cytotoxic activity
Clinical Applications
Oncology: Proven anticancer efficacy Cytotoxicity: Selective cancer cell targeting Safety: Established therapeutic window
Manufacturing Performance
Yield: 95% pharmaceutical grade recovery Purity: >99% cytotoxic specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Oncology Excellence

Superior cytotoxic pharmaceutical grade with proven anticancer performance and regulatory compliance

Reliable Supply

Guaranteed cytotoxic supply with specialized inventory management and oncology production scheduling

Oncology Expertise

Dedicated oncology development team with specialized cytotoxic formulation support

Regulatory Compliance

Complete oncology documentation with specialized DMF and international compliance

Global Standards

International oncology compliance with USP, EP, and ICH cytotoxic guidelines

Partnership Approach

Collaborative oncology relationships with specialized cytotoxic development services