Amiodarone HCl
Pharmaceutical Premium
Pharmaceutical API

Amiodarone HCl

High-purity pharmaceutical grade Amiodarone HCl manufactured to meet stringent USP/EP specifications for pharmaceutical formulations and research applications. Our pharmaceutical grade material delivers exceptional purity and consistency for critical pharmaceutical manufacturing.

  • USP/EP Grade Specifications
  • High Purity (≥99.0%)
  • Comprehensive Analytical Testing
  • Regulatory Compliance Documentation
  • Pharmaceutical Manufacturing Grade
  • Quality Assurance Certified
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Technical Specifications

Chemical Formula: C25H29I2NO3·HCl
CAS Number: 19774-82-4
Molecular Weight: 681.78 g/mol
Purity (HPLC): ≥99.0% (pharmaceutical grade)
Physical State: White to off-white crystalline powder
Water Content (Karl Fischer): ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Related Substances: ≤1.0% total impurities
Storage Conditions: Store protected from light (15-30°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Cardiovascular Drug Manufacturing
Antiarrhythmic Formulations
Oral Pharmaceutical Products
API Synthesis & Development
Cardiac Research Applications
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 Amiodarone HCl grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥99.0% (HPLC) Water Content: ≤0.5% 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: ≤1.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥99.5% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Injection formulations

Quality Standards

DRAVYOM's pharmaceutical grade Amiodarone HCl 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
Comprehensive Impurity Control
Batch-to-Batch Consistency
Complete Documentation Package
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

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

Analytical Properties
Solubility (Water): Slightly soluble
LogP (octanol/water): 7.6
pKa: 8.8 ± 0.1
UV λmax: 242 nm (methanol)
Physical Properties
Melting Point: 159-163°C
Bulk Density: 0.4-0.6 g/mL
Crystalline Form: White to cream powder
Hygroscopicity: Non-hygroscopic
Pharmaceutical Performance
Bioavailability: 22-86% (variable)
Protein Binding: 96%
Half-life: 25-100 days
Metabolism: Hepatic (CYP3A4, CYP2C8)
Purity Specifications
Assay (HPLC): ≥99.0%
Related Substances: ≤1.0% total
Water Content: ≤0.5% (Karl Fischer)
Residue on Ignition: ≤0.1%
Stability Properties
Shelf Life: 3 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable 15-25°C
Photostability: Store in amber containers

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Amiodarone HCl superiority in cardiovascular applications with exceptional antiarrhythmic efficacy, precision, and reproducibility across diverse cardiac treatment protocols and research procedures.

Pharmaceutical Performance

Assay: ≥99.0% active pharmaceutical ingredient

Exceptional purity for cardiovascular formulations
Antiarrhythmic Activity

Efficacy: Multi-channel blocking action

Superior cardiac rhythm stabilization
Dissolution Rate

Solubility: Optimized for absorption

Enhanced bioavailability characteristics
Thermal Stability

Working range: 15-25°C optimal storage

Maintains potency across temperature range
Batch Consistency

Variation: ±0.2% between manufacturing batches

Exceptional lot-to-lot reproducibility
Extended Stability

3 years shelf life under recommended conditions

Long-term pharmaceutical grade integrity

Safety Information

Potent cardiovascular pharmaceutical requiring specialized handling procedures. Use appropriate personal protective equipment and follow institutional drug handling protocols. Avoid skin contact and inhalation. Handle in well-ventilated areas with proper safety precautions due to photosensitivity concerns.

Health Hazard
Photosensitive
Avoid Contact

Storage & Handling

Store in original amber containers in a cool, dry area (15-25°C) away from light and incompatible materials. Keep containers tightly closed and protect from moisture and light exposure. Use specialized pharmaceutical storage protocols for photosensitive compounds and ensure proper material segregation.

Controlled temperature (15-25°C)
Protect from light
Amber containers required
Protect from moisture

Chemical Mechanisms & Reaction Pathways

Amiodarone HCl exhibits antiarrhythmic properties through multiple ion channel blockade, enabling precise cardiovascular applications with predictable pharmacokinetic pathways and quantitative rhythm control mechanisms.

Ion Channel Blockade

Multi-channel blockade including sodium, potassium, and calcium channels

Quantitative cardiac rhythm stabilization
Beta-Adrenergic Effects

Non-competitive beta-adrenergic receptor antagonism

Essential for comprehensive cardiac protection
Thyroid Modulation

Inhibition of peripheral thyroid hormone conversion

Enables metabolic effects monitoring
Membrane Stabilization

Direct cardiac membrane stabilizing effects

Comprehensive antiarrhythmic activity

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical analysis

ICH Guidelines

International Conference on Harmonization pharmaceutical compliance

FDA Registration

United States Food and Drug Administration compliance

Method Validation

Supported analytical method validation documentation

SDS Documentation

Multi-language Safety Data Sheets (16 sections, GHS compliant)

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, stability testing assistance, and regulatory services to optimize pharmaceutical grade Amiodarone HCl performance in your specific therapeutic applications.

Formulation Development
  • Pharmaceutical formulation optimization support
  • Stability testing guidance
  • Bioavailability and bioequivalence validation
  • Custom pharmaceutical procedures
Analytical Services
  • Certificate of Analysis verification
  • Custom purity analysis
  • Impurity profiling and identification
  • Method validation support
Technical Support
  • Pharmaceutical troubleshooting consultation
  • Storage and handling guidance
  • Safety training and protocols
  • Manufacturing best practices
Supply Solutions
  • Consistent batch scheduling
  • Emergency supply arrangements
  • Custom packaging options
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical grade Amiodarone HCl production emphasizes environmental responsibility through sustainable manufacturing practices, waste minimization, and comprehensive environmental impact management for pharmaceutical operations.

Waste Minimization

Optimized production with minimal waste generation

Water Treatment

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive guidance for pharmaceutical waste management

ISO 14001

Environmental management system certified production

Container Recycling

Pharmaceutical container return and recycling programs

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in controlled cGMP environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing protocol including purity, impurities, and stability

HPLC verification and spectroscopic analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical manufacturing accreditation

Continuous improvement and process validation
Packaging Control

Pharmaceutical containers with controlled atmosphere packaging

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating pharmaceutical grade Amiodarone HCl effectiveness across diverse therapeutic applications with quantified performance metrics and clinical study validations.

Pharmaceutical Manufacturing
Purity: >99.5% pharmaceutical grade Bioavailability: Consistent therapeutic levels Stability: 36+ months under controlled conditions
Research Institutions
Clinical Studies: 1000+ published research applications Reproducibility: >98% batch-to-batch consistency Innovation: Custom grade development
Generic Manufacturing
Regulatory Success: 100% FDA approval support Cost Efficiency: 25% reduction in manufacturing costs Quality Assurance: Zero batch failures

DRAVYOM Competitive Advantages

Superior Purity

Consistently exceeds pharmaceutical specifications with ultra-low impurities and exceptional therapeutic performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production scheduling

Pharmaceutical Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Quality Assurance

Traceable certificates with comprehensive analytical data and regulatory compliance support

Global Standards

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

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom development services