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Product Name: Amiodarone Hydrochloride
Synonyms: Cordarone, Pacerone
Molecular Formula: C25H29I2NO3·HCl
Molecular Weight: 681.78 g/mol
Chemical Family: Benzofuran derivative
Recommended Use: Antiarrhythmic pharmaceutical ingredient for clinical and laboratory settings
CAS Number: 19774-82-4
Manufacturer Contact: As listed on product packaging or shipment documents
Emergency Contact: National poison control and local fire department, as appropriate
Classification: Acute toxicity, skin irritation, specific target organ toxicity – repeated exposure
Signal Word: Danger
Hazard Statements: Harmful if swallowed, causes skin and eye irritation, may damage liver, thyroid, lungs through prolonged exposure
Precautionary Statements: Avoid breathing dust, wear protective gloves/eye protection, wash after handling, do not eat or drink while using product
Physical Hazards: May form combustible dust concentrations in air during processing
Health Hazards: May cause organ damage by repeated or prolonged exposure. Sensitization possible with contact
Environmental Hazards: Toxic to aquatic life with long lasting effects
Chemical Name: Amiodarone Hydrochloride
Content: >99% (pharmaceutical grade)
Impurities: Trace related compounds <1%, primarily other benzofuran derivatives due to manufacturing process
Other Additives: None
General: Remove affected individual from exposure; get medical advice immediately
If Inhaled: Move person to fresh air. Keep comfortable. Seek medical attention if symptoms occur
Skin Contact: Take off contaminated clothing. Rinse skin thoroughly with soap and water for several minutes. Medical attention if irritation persists
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, seek immediate medical attention
If Swallowed: Rinse mouth, do not induce vomiting unless directed by physician. Seek urgent medical help and show product label
Most Important Symptoms/Effects: Eye, skin, mucous membrane irritation, respiratory issues, nausea, dizziness, liver injury with repeated exposure
Note to Physicians: Symptomatic and supportive treatment recommended; monitor for arrhythmias and hepatic/thyroid toxicity
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide. Avoid high pressure water jets
Unsuitable Media: Direct water jet in enclosed areas may disperse dust and increase fire risk
Specific Hazards: Forms hazardous combustion products like hydrogen chloride, nitrogen oxides, carbon monoxide, iodine vapors
Protective Equipment: Full protective gear and self-contained breathing apparatus required for all emergency responders
Firefighting Advice: Remove containers from path of fire, cool with water spray from safe distance, prevent runoff to sewers/waterways
Personal Precautions: Evacuate area; keep unnecessary personnel away. Avoid dust formation. Wear PPE including gloves, goggles, and suitable respiratory protection
Environmental Precautions: Prevent entry into sewers, surface water, or soil. Notify relevant authorities as required
Methods for Clean-Up: Sweep up and place in suitable, labeled waste containers for disposal. Use non-sparking tools, ventilate area, wash site with water after removal
Other Advice: Dispose in accordance with local, regional, national regulations. Avoid generating dust during clean-up
Handling: Minimize dust generation, avoid contact with skin, eyes, clothing. Do not breathe dust. Use only in well-ventilated areas. Wash hands thoroughly after use
Storage: Store in tightly closed original container, protected from light, in a dry, cool, and well-ventilated place. Maintain away from incompatible materials like oxidizers and acids
Special Requirements: Ensure storage area is designed to avoid dust buildup. Limit access to trained personnel
Packaging Materials: Keep in original packaging or suitable inert containers to prevent contamination
Occupational Exposure Limits: No established OSHA/NIOSH limits; pharmaceutical exposure limit usually 0.1 mg/m³ as 8-hour TWA
Engineering Controls: General and local exhaust ventilation must control airborne dust. Enclosed process recommended where feasible
Personal Protective Equipment: Nitrile gloves, laboratory coat, safety goggles, and dust respirator recommended. Contaminated clothing should be removed and washed
Hygiene Measures: Prohibit eating, drinking, and smoking in work areas. Wash hands before breaks and after handling substance
Appearance: White to off-white crystalline powder
Odor: Odorless
pH: Slightly acidic (in aqueous solution)
Melting Point: 150-160°C
Boiling Point: Decomposes before boiling
Solubility: Soluble in DMSO and methanol; sparingly soluble in water
Vapor Pressure: Negligible at ambient temperature
Specific Gravity: 1.7 to 1.8
Flash Point: Not available
Partition Coefficient (log Kow): 7.6
Stability During Storage: Stable under recommended storage conditions
Chemical Stability: Stable under normal temperatures and pressures if stored properly
Reactivity: May react with strong oxidizers, acids, and bases
Conditions to Avoid: Heat, moisture, incompatible materials
Hazardous Decomposition Products: Hydrogen chloride, nitrogen oxides, carbon monoxide, carbon dioxide, iodine vapors possible in fire
Polymerization: Product does not polymerize
Routes of Exposure: Inhalation, skin, eye contact, ingestion
Acute Toxicity: LD50 (oral, rat) approximately 300 mg/kg; irritant to skin, eyes, and respiratory tract
Chronic Toxicity: Liver, thyroid, and lung toxicity observed after prolonged/repeated exposure
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Reproductive Effects: May cause fetal harm; animal data show developmental toxicity at high doses
Other Effects: Photosensitivity, pulmonary toxicity, neurotoxicity with long-term use
Ecotoxicity: Toxic to aquatic life, especially fish and invertebrates. May cause long-lasting adverse effects in aquatic environments
Persistence and Degradability: Low biodegradability. Remains in the environment for extended periods
Bioaccumulative Potential: High, based on log Kow value
Mobility in Soil: Low water solubility; expected to bind to soil and sediment
Other Adverse Effects: Active pharmaceutical ingredient poses risk to non-target organisms if released into environment
Waste Disposal Methods: Incinerate in approved facility using hazardous waste protocols. Follow local, regional, and federal regulations
Contaminated Packaging: Treat as hazardous. Clean thoroughly before recycling or disposal according to regulations
Precautions: Avoid uncontrolled release. Never dispose with regular solid waste or in water systems
Disposal Advice: Consult environmental authority or licensed waste contractor for proper procedure
UN Number: Not designated for transport regulation under normal pharmaceutical packaging
UN Proper Shipping Name: Not regulated as a dangerous good in shipment in finished dosage or limited quantities
Transport Hazard Class: None assigned for ground, air, or sea under normal handling
Packing Group: Not applicable
Environmental Hazards: Not considered a marine pollutant in small quantities
Special Transport Precautions: Product must be securely packed to prevent leakage and dust generation
U.S. Regulations: This material and its uses are regulated under FDA for pharmaceutical applications. Not listed on SARA, CERCLA, or CAA regulated substances for bulk ingredient. Prescription drug law applies
International Regulations: Listed in relevant inventories in EU, Japan, Canada, Australia; subject to national poisons schedules
Workplace Regulations: Subject to occupational exposure controls and reporting under local safety standards
GHS Labeling: Classified under health hazard categories for acute toxicity and specific target organ toxicity (repeated exposure)
Other Regulatory References: Pharmaceutical substance - restrictions on use, export, and handling may apply beyond local requirements
