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Product Name: Dronedarone Hydrochloride
Chemical Family: Benzofuran derivative
Chemical Formula: C31H44N2O5S·HCl
Molecular Weight: 593.2 g/mol
CAS Number: 141625-93-6
Intended Use: Pharmaceutical intermediate, research and development
Supplier: Major pharmaceutical manufacturers and research institutions handle sourcing and distribution
Emergency Contact: Designated chemical or occupational health emergency hotline
Classification: Irritant to skin, eyes; harmful if swallowed; possible respiratory tract irritant
Signal Word: Warning
Hazard Statements: May cause eye, skin, and respiratory tract irritation; may be harmful if ingested or inhaled; hazardous by international transport regulations
Precautionary Statements: Avoid inhalation, contact with skin and eyes; handle under fume hood or controlled ventilation
GHS Label Elements: Exclamation mark symbol, avoid direct release to environment
Target Organs: Eyes, respiratory system, gastrointestinal tract
Chemical Name: Dronedarone Hydrochloride
Purity: Typically ≥98% (pharmaceutical grade)
Components: Active ingredient (Dronedarone Hydrochloride), trace process solvents <0.1%, salt forms
Other Impurities: Not commonly detected above threshold values requiring disclosure
Inhalation: Move to fresh air, monitor breathing, provide oxygen if difficulty occurs, seek medical attention for any signs of respiratory distress
Skin Contact: Immediately wash affected area with plenty of water and soap, remove contaminated clothing, do not reuse clothing until cleaned, obtain medical attention for persistent irritation
Eye Contact: Rinse cautiously with clean water for at least 15 minutes, keeping eyelids apart; remove contact lenses if present and easy to do, continue rinsing, seek prompt medical evaluation
Ingestion: Rinse mouth with clean water, do not give anything orally to an unconscious person, avoid inducing vomiting unless directed by medical personnel, seek immediate medical advice or poison control guidance
Suitable Extinguishing Media: Use water spray, dry chemical powder, carbon dioxide, or foam as appropriate for surrounding materials
Specific Hazards: May emit toxic fumes under fire conditions, such as hydrogen chloride, oxides of nitrogen and sulfur, carbon monoxide and dioxide
Protective Equipment: Firefighters wear self-contained breathing apparatus and full protective gear to prevent skin and eye contact with fumes or contaminated water
Advice for Firefighters: Avoid breathing vapors, stay upwind, cool unaffected containers with water spray, use caution due to slippery residues after response
Personal Precautions: Avoid dust formation, keep away from open flames and sources of ignition, use protective equipment including gloves, lab coat, safety goggles, and dust mask or respirator as hazards dictate
Environmental Precautions: Prevent spillage from entering drains, waterways, or soil; contain using inert absorbent material
Cleanup Methods: Sweep up without generating dust, collect in suitable container for disposal, ventilate area after material has been removed, clean spill area with water and detergent
Handling: Manage using safe chemical hygiene practices; wear suitable personal protective equipment; handle within designated areas to minimize exposure risk
Ventilation: Employ local exhaust ventilation or work in fume hood whenever possible
Storage: Store in cool, dry, well-ventilated area apart from incompatible substances, keep container tightly closed, protect from light and moisture, label clearly
Storage Temperature: Recommended range 2–8°C unless specified otherwise by manufacturer
Occupational Exposure Limits: No specific regulatory limits available; minimize occupational exposure using good industrial hygiene practice
Engineering Controls: Fume hood, laboratory exhaust, safety shower, and eyewash station access in work areas
Personal Protective Equipment (PPE): Laboratory gloves (nitrile or latex), protective goggles, lab coat, dust mask or respirator when handling powder
Hygiene Measures: Wash hands and face after handling, remove contaminated clothing, do not eat, drink, or smoke in work area
Physical State: Solid powder
Color: White to off-white
Odor: Odorless or faint characteristic smell
pH (1% w/v in water): Acidic in solution, typically below 7
Melting Point: Range 210–216°C (report varies depending on source)
Boiling Point: Not readily determined, decomposes before boiling
Solubility: Soluble in dimethyl sulfoxide, sparingly soluble in water, slightly soluble in ethanol
Partition Coefficient (Log P): Data available from published research for drug development use
Vapor Pressure: Negligible at room temperature
Density: Not broadly reported, estimated above 1 g/cm3
Molecular Structure: Complex polycyclic aromatic with ether and sulfonamide groups
Chemical Stability: Stable under recommended storage conditions, protect from moisture and excessive heat
Conditions to Avoid: Prolonged exposure to air, incompatible materials, ignition sources, direct sunlight
Incompatible Materials: Strong oxidizing agents, strong acids or bases, moisture
Hazardous Decomposition Products: Hydrogen chloride, nitrogen oxides, sulfur oxides
Polymerization: No hazardous polymerization expected during normal use
Acute Toxicity: Experimental oral LD50 (rat) typically exceeds 2000 mg/kg; actual clinical toxicity profile shaped by patient pharmacology
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Health Effects: May cause symptoms such as coughing, irritation, potential hepatotoxicity with prolonged or repeated exposure
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Mutagenicity and Reproductive Effects: No significant mutagenic findings reported in in vitro or animal studies; not expected to cause reproductive harm in occupational exposure context
Specific Target Organ Toxicity: Some studies point to possible liver and cardiovascular effects with repeated exposure beyond workplace norms
Chronic Exposure: Not expected to produce adverse effects with good laboratory practice
Ecotoxicity: No comprehensive aquatic toxicity data reported; related compounds may affect aquatic life and bioaccumulate
Persistence and Degradability: Not rapidly biodegradable, persistence possible in soil and sediment
Bioaccumulative Potential: Moderate to high potential based on molecular structure and log Kow values for related pharmacological agents
Mobility in Soil: Limited mobility, sorption to organic matter likely
Other Harmful Effects: Disruption of wastewater treatment possible if released in large amounts, limit release to environment; consult country-specific guidance for pharmaceutical disposal
Disposal Methods: Dispose of unused product and contaminated packaging as hazardous chemical waste; incineration at approved facility according to local, national, and international regulations
Packaging Disposal: Triple rinse containers before final disposal, label as hazardous waste
Precautions: Do not discharge into sewers or natural bodies of water; consult environmental authority for best practice
Recycling and Recovery: Unused portions not suitable for recycling due to drug activity
UN Number: Classified according to country-specific hazardous material regulation
Proper Shipping Name: Dronedarone Hydrochloride (pharmaceutical intermediate, hazardous solid, NOS)
Transport Hazard Class: Not typically assigned a specific hazard class; check transporter’s rules
Packaging Requirements: Inner container leakproof, overpacked in shock-resistant secondary packaging, clearly labeled
Environmental Hazards: Not classified as marine pollutant for small shipments
Special Precautions: Emergency procedures for accidental release during transport must be planned and documented
Global Inventory Listings: Registration or notification under chemical control authorities of major countries as pharmaceutical or research compound
OSHA Status: Not regulated under specific OSHA chemical standards; treated as hazardous chemical in laboratory setting
TSCA Status: Not listed for general commerce; research or importation restrictions may apply
EU REACH Status: Exemption as medicinal product, otherwise subject to notification
National and Local Regulation: Pharmaceutical regulations, drug precursor control, and hazardous substance codes apply; reference country-specific workplace and import regulations for details
Labeling Requirements: Conform to latest transport and laboratory-specific hazard communication regulations
