Palonosetron Hydrochloride API
Pharmaceutical Oncology
Pharmaceutical API

Palonosetron Hydrochloride

High-purity pharmaceutical grade Palonosetron Hydrochloride API manufactured to meet stringent USP/EP specifications for antiemetic formulations. Our pharmaceutical grade API delivers exceptional purity and consistency for critical 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: C19H24N2O·HCl
CAS Number: 135729-62-3
EINECS Number: Not applicable
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White to off-white crystalline powder
Molecular Weight: 332.87 g/mol
Melting Point: 225-230°C
pH (1% solution): 4.5-6.5
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 3 years from manufacture date
Packaging Options: 1g, 5g, 25g containers

Applications

Antiemetic Therapy
Chemotherapy-Induced Nausea
Injectable Solutions
5-HT3 Receptor Antagonist
IV Infusion Preparations
Post-Operative Nausea
Cancer Supportive Care
Radiotherapy-Induced Nausea
Gastroenterology Research
Clinical Trials
Antiemetic Drug Development
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Palonosetron Hydrochloride grades tailored for specific antiemetic applications, ensuring optimal 5-HT3 receptor antagonism and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% 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 antiemetic therapy
Research Grade
Purity: ≥98.0% Activity: Verified Stability: Enhanced Application: Gastroenterology research

Quality Standards

DRAVYOM's Palonosetron Hydrochloride is manufactured under stringent cGMP protocols, meeting international antiemetic drug standards including USP, EP, and FDA guidelines for nausea and vomiting prevention applications.

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

Advanced Chemical Properties & Performance

Palonosetron Hydrochloride exhibits exceptional 5-HT3 receptor antagonist properties essential for antiemetic applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding nausea and vomiting prevention formulations.

Molecular Properties
Molecular Weight: 332.87 g/mol
LogP: 2.45
pKa: 9.75
Bioavailability: 97%
Physical Properties
Melting Point: 280-285°C
Solubility (Water): 5.5 mg/mL
Crystalline Form: Stable polymorph
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
5-HT3 Receptor Ki: 0.21 nM
Antiemetic Duration: 40 hours
Selectivity: 5-HT3 selective
Stability: Stable in solid state
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable at room temperature
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Palonosetron Hydrochloride superiority in antiemetic applications with exceptional 5-HT3 receptor binding, bioavailability, and reproducibility across diverse nausea prevention formulations.

Receptor Binding

Ki: 0.21 nM for 5-HT3 receptors

High-affinity selective binding
Bioavailability

IV: 97% absolute bioavailability

Excellent drug absorption
Stability

Solid state: >5 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade antiemetic API requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for antiemetic APIs and ensure proper waste disposal procedures.

Pharmaceutical API
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.

Cool storage (2-8°C)
Protect from light
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Palonosetron hydrochloride demonstrates potent antiemetic activity through selective 5-HT3 receptor antagonism with unique pharmacokinetic properties, providing extended duration of action and superior prevention of delayed nausea and vomiting.

5-HT3 Receptor Blockade

Highly selective serotonin type 3 receptor antagonism

Extended receptor binding duration
Extended Half-life

Prolonged elimination half-life compared to other 5-HT3 antagonists

Superior delayed nausea prevention
CTZ Inhibition

Chemoreceptor trigger zone activity blockade

Prevention of chemotherapy-induced emesis
Allosteric Modulation

Unique allosteric binding and receptor interaction

Enhanced antiemetic efficacy

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 Palonosetron hydrochloride performance in pharmaceutical applications.

Formulation Development
  • Injectable formulation development
  • Oral dosage form optimization
  • Stability enhancement strategies
  • Compatibility studies
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • 5-HT3 receptor binding assays
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 Palonosetron hydrochloride 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 Palonosetron hydrochloride 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, LC-MS, and receptor binding assays
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 Palonosetron hydrochloride effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Bioavailability: >95% intravenous delivery Half-life: 40+ hours elimination Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Antiemetic products Regulatory Success: Global approvals achieved Innovation: Extended-action formulations
Clinical Applications
Efficacy: Superior delayed nausea prevention Safety: Excellent tolerance profile Versatility: Oncology and PONV applications

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