Product Name: Rocuronium Bromide
Chemical Name: 1-[17β-Acetoxy-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-methylpiperidinium bromide
Synonyms: Rocuronium; Esmeron
Recommended Use: Neuromuscular blocking agent in anesthesia
Manufacturer: [Manufacturer Information]
Emergency Phone: [Emergency Contact Number]
CAS Number: 119302-91-9
UN Number: UN2811 (if transported in bulk form)
GHS Classification: Acute Toxicity – Oral, Category 3; Acute Toxicity – Inhalation, Category 3
GHS Label Elements: Skull and crossbones, Danger
Hazard Statements: Toxic if swallowed or inhaled, Can cause muscle paralysis and respiratory failure
Precautionary Statements: Wear protective gear, Avoid release into environment, Do not eat or drink around product
Health Hazards: Paralysis of skeletal muscles including respiratory
Environmental Hazards: Harmful to aquatic organisms
Routes of Exposure: Inhalation, Ingestion, Skin and Eye Contact
Chemical Name: Rocuronium Bromide
Concentration: >98% (as supplied)
Chemical Formula: C32H53BrN2O4
Molecular Weight: 609.7 g/mol
Impurities: Trace organic and inorganic
Additives: None typically present in raw material
Other Ingredients: None identified as hazardous in pure form
Inhalation: Move exposed individual to fresh air, Seek immediate medical attention, Supply artificial respiration if breathing stops
Ingestion: Rinse mouth thoroughly, Do not induce vomiting, Seek emergency medical care
Skin Contact: Remove contaminated clothing, Wash skin with soap and water, Seek medical attention if symptoms occur
Eye Contact: Rinse cautiously with water for at least 15 minutes, Remove contact lenses if present, Seek medical help
General Advice: Keep patient calm and warm, Monitor breathing and pulse, Inform medical personnel about nature of exposure
Suitable Extinguishing Media: Use dry chemical, CO2, or alcohol-resistant foam, Use water spray to cool exposed containers
Hazardous Combustion Products: Hydrogen bromide, nitrogen oxides, carbon monoxide, carbon dioxide
Special Protective Equipment: Wear self-contained breathing apparatus, Use full protective gear
Fire Hazards: Product does not burn easily but may emit toxic fumes at high temperatures, Avoid inhaling combustion products
Precautions: Remove containers from fire area if safe, Prevent fire runoff from entering drains or water sources
Personal Precautions: Avoid contact with skin, eyes, Use suitable PPE including gloves and goggles
Environmental Precautions: Prevent release into drains, surface waters, soils
Containment: Sweep up, Place in labeled, tightly sealed containers for proper disposal
Cleanup Methods: Ventilate spill area, Mop or wipe with damp cloth, Wash down spill area with water and detergent, Dispose contaminated cleaning materials safely
Notification: Report significant spills to regulatory authorities as required
Handling: Avoid breathing dust, vapor, Use appropriate local ventilation, Do not ingest, Practice good industrial hygiene
Storage: Store tightly closed in cool, dry, well-ventilated area, Protect from light and incompatible materials
Incompatibilities: Strong oxidizers, acid chlorides
Special Requirements: Access to emergency shower and eyewash station recommended
Storage Class: Control substance: regulated storage may apply depending on jurisdiction
Engineering Controls: Use laboratory fume hood, Enclosed processes
Exposure Limits: None established for rocuronium bromide, Handle as hazardous chemical
Personal Protective Equipment: Chemical-resistant gloves (nitrile or latex), Lab coat, Eye protection, Respiratory protection if dust is present
Workplace Hygiene Measures: Wash hands after handling, Remove contaminated clothing for cleaning
Environmental Exposure Controls: Prevent entry into environment, Treat waste responsibly
Appearance: White or almost white crystalline powder
Odor: Odorless
Odor Threshold: No data available
pH: 4.0–5.0 (in aqueous solution)
Melting Point/Freezing Point: No data available
Boiling Point: No data available
Flash Point: No data available
Evaporation Rate: Not determined
Flammability: Not flammable under normal conditions
Vapor Pressure: Negligible
Solubility: Freely soluble in water, Slightly soluble in ethanol
Partition Coefficient (n-octanol/water): No data available
Auto-ignition Temperature: Not self-igniting
Decomposition Temperature: Not determined
Viscosity: Not applicable
Chemical Stability: Stable at normal temperature and pressure
Conditions to Avoid: High heat, Strong light, Moisture
Incompatible Materials: Oxidizing agents, Acids
Hazardous Decomposition Products: Hydrogen bromide, carbon monoxide, nitrogen oxides on combustion or thermal decomposition
Possibility of Hazardous Reactions: Product does not polymerize, Avoid mixing with incompatible materials
Acute Toxicity: Can cause muscle paralysis; Animal studies show LD50 (mice, IV) = 0.49 mg/kg
Irritation: May cause mild irritation to skin and eyes
Sensitization: Evidence inadequate
Chronic Effects: No significant chronic toxicity data for humans
Carcinogenicity: Not classified as carcinogen by IARC, NTP, or OSHA
Mutagenicity: In vitro tests did not show mutagenic effects
Reproductive Toxicity: No adverse effects observed in animal studies at therapeutic doses
Routes of Exposure: Accidental injection, oral, inhalation, skin and eye contact
Symptoms of Overexposure: Respiratory depression, muscle weakness, apnea, hypotension
Ecotoxicity: Data limited, Chemical may harm aquatic life, Avoid environmental release
Persistence and Degradability: Biodegradation rate not characterized fully
Bioaccumulative Potential: Low based on structure and properties
Mobility in Soil: Likely mobile when water soluble
Other Adverse Effects: Unknown influences on ecosystem, Best to contain and prevent entry to watercourses
Disposal Methods: Treat as hazardous waste, Incinerate in approved facility, Do not discharge into drains or normal waste streams
Contaminated Packaging: Rinse and dispose of in line with local chemical disposal regulations
Special Precautions: Label waste for contents and hazards, Notify disposal personnel about identity of material
Regulatory Requirements: Compliance with federal, state, and local laws required
UN Number: UN2811 (Toxic solid, organic, n.o.s.)
Transport Hazard Class: Class 6.1 (Toxic substances)
Packing Group: III
Proper Shipping Name: Toxic solid, organic, n.o.s. (contains Rocuronium Bromide)
Marine Pollutant: No data suggesting specific marine hazard, Best practice to avoid release
Special Transport Precautions: Secure packaging, Label for toxicity, Protect from moisture and breakage
Transport Regulations: Follow ICAO/IATA, IMDG, ADR requirements as suited to shipment method
OSHA Status: Regulated as hazardous based on acute toxicity
WHMIS Classification (Canada): D1A – Very toxic material
TSCA Status: Not listed for commercial distribution in the United States
SARA Title III (Sections 311/312): Acute health hazard
RCRA Status: Not classified as hazardous waste but handle with care
Other Regulatory Data: Drug schedule and controlled substance status varies by country
European Regulations: Classified as hazardous according to Regulation (EC) No. 1272/2008
