Ondansetron HCl Base API
Pharmaceutical Premium
Pharmaceutical API

Ondansetron HCl Base

High-purity pharmaceutical grade Ondansetron HCl Base API manufactured to meet stringent USP/EP specifications for antiemetic and nausea prevention 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: C18H19N3O·HCl
CAS Number: 99614-02-5
Molecular Weight: 329.83 g/mol
Physical State: White to off-white crystalline powder
Purity (HPLC): ≥99.0% (USP/EP Grade)
pH (1% solution): 3.5-5.0
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% (total impurities)
Chloride Content: 10.5-11.5% (as HCl)
Solubility: Freely soluble in water
Storage Conditions: Store at room temperature, protect from light
Shelf Life: 3 years from date of manufacture
Packaging Options: 25g, 50g, 100g pharmaceutical containers

Applications

Oral Tablet Formulations
Injectable Formulations
Antiemetic Therapy
Chemotherapy Support
5-HT3 Receptor Antagonist
Postoperative Nausea
Nausea Prevention
Oncology Support
Pharmaceutical Research
Clinical Applications
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Ondansetron HCl Base grades tailored for specific antiemetic pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse nausea prevention therapeutic applications.

USP Grade (United States Pharmacopeia)
Purity: ≥99.0% (HPLC) Related Substances: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% (HPLC) pH: 3.5-5.0 (1% solution) Chloride Content: 10.5-11.5% Application: EU regulatory submissions
Antiemetic Grade
Purity: ≥99.5% (HPLC) Receptor Activity: Verified Endotoxin: ≤0.25 EU/mg Application: Specialized antiemetics
Injectable Grade
Purity: ≥99.8% (HPLC) Sterility: Compliant Particulate Matter: <25 µm Application: Injectable formulations

Quality Standards

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

ISO 9001:2015 Certified Manufacturing
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Antiemetic Testing
5-HT3 Antagonist Grade
Batch-to-Batch Consistency
Comprehensive COA
Pharmaceutical Grade Packaging

Advanced Chemical Properties & Performance

Ondansetron HCl Base 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: 293.36 g/mol
LogP: 2.3
pKa: 7.4
Bioavailability: 60%
Physical Properties
Melting Point: 182-185°C
Solubility (Water): 0.1 mg/mL
Crystalline Form: Stable base form
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
5-HT3 Receptor Ki: 1.9 nM
Antiemetic Duration: 8-12 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 Ondansetron HCl Base superiority in antiemetic applications with exceptional 5-HT3 receptor binding, bioavailability, and reproducibility across diverse nausea prevention formulations.

Receptor Binding

Ki: 1.9 nM for 5-HT3 receptors

High-affinity selective binding
Bioavailability

Oral: 60% absolute bioavailability

Good 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

Ondansetron HCl base demonstrates potent antiemetic activity through selective 5-HT3 receptor antagonism, providing effective prevention and treatment of nausea and vomiting with excellent safety profile.

5-HT3 Receptor Blockade

Selective serotonin type 3 receptor antagonism

Central and peripheral antiemetic activity
CTZ Inhibition

Chemoreceptor trigger zone activity blockade

Prevention of chemotherapy-induced nausea
Vagal Nerve Block

Peripheral vagal nerve 5-HT3 receptor inhibition

Gastrointestinal antiemetic effects
Pharmacokinetic Profile

Excellent bioavailability with predictable kinetics

Reliable therapeutic dosing

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 Ondansetron HCl performance in pharmaceutical applications.

Formulation Development
  • Tablet and ODT formulations
  • Injectable solutions
  • Oral solution development
  • Stability enhancement strategies
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Dissolution testing support
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Flexible packaging options
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Ondansetron HCl 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 Ondansetron HCl 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 pharmacopeial methods
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 Ondansetron HCl effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Bioavailability: >95% oral absorption Stability: 3+ years shelf life Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Antiemetic products Regulatory Success: Global approvals achieved Innovation: Multiple dosage forms
Clinical Applications
Efficacy: Superior antiemetic activity Safety: Excellent tolerance profile Versatility: Multiple therapeutic uses

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