Product Name: Rocuronium Bromide
Chemical Name: 1-[17β-(Acetoxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-methylpiperidinium bromide
Synonyms: Zemuron, Esmeron
CAS Number: 119302-91-9
Molecular Formula: C32H53BrN2O4
Recommended Use: Neuromuscular blocking agent in anesthesia
Manufacturer: Pharmaceutical laboratories or hospital pharmacy providers
Emergency Contact: Refer to local poison center or medical facility
GHS Classification: Toxic to specific target organs; hazardous if inhaled, swallowed, or upon skin exposure
Signal Word: Danger
Hazard Statements: Causes difficulty breathing, muscle paralysis, may be fatal if used improperly
Pictograms: Skull and crossbones, exclamation mark
Precautionary Statements: Avoid all unprotected contact, wash hands thoroughly after handling, wear suitable PPE, never administer unless trained
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Effects: Skeletal muscle relaxation, risk of respiratory arrest
Chronic Effects: Not well established, use under controlled conditions required
Chemical: Rocuronium Bromide
Concentration: ≥ 98% (active pharmaceutical ingredient)
Impurities: Less than 2%, non-hazardous
Other Ingredients: Pharmaceutical grade excipients as per formulation, not hazardous by standard definitions
EC Number: Not established
INCI Name: Rocuronium Bromide
Inhalation: Move person to fresh air immediately, supply oxygen or artificial respiration if breathing has stopped, seek medical attention without delay
Ingestion: Seek immediate medical help, do not induce vomiting, provide airway protection if unconscious
Skin Contact: Remove contaminated clothing, flush skin with large amounts of water, seek medical review for systemic effects
Eye Contact: Rinse eyes with water for 15 minutes, lift eyelids occasionally, seek urgent ophthalmological evaluation
Note to Physicians: Support and monitor respiratory function closely, provide symptomatic and supportive care, maintain airway patency
Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or CO2
Fire Hazards: Not highly flammable, toxic fumes (nitrogen oxides, bromine compounds) produced during combustion
Protective Equipment: Full protective gear and self-contained breathing apparatus required
Specific Risks: Avoid inhalation of fumes, consider evacuating area, cool exposed containers with water
Personal Precautions: Wear gloves, goggles, and lab coat, avoid contact with skin or eyes, ensure adequate ventilation
Environmental Precautions: Prevent spillage from reaching drains or open water sources
Methods for Cleaning Up: Absorb with inert material (vermiculite, sand), transfer to sealed waste container for controlled disposal, wash contaminated area thoroughly, dispose of all cleanup materials as hazardous waste
Handling: Use only in environments with proper ventilation and controls, avoid unprotected exposure, trained personnel should handle, do not eat, drink, or smoke in work areas
Storage: Store in tightly closed containers, away from incompatible substances like strong oxidizers or acids, maintain temperature at 2-8°C (refrigerated), secure storage to prevent unauthorized access
Special Storage Conditions: Protect from light and moisture, label containers clearly, keep away from food and drink
Occupational Exposure Limits: No established exposure limits for Rocuronium Bromide, handle as hazardous pharmaceutical
Engineering Controls: Handle in fume hood or with local exhaust ventilation
Personal Protective Equipment: Wear nitrile gloves, safety goggles, lab coats, and face shield if risk of splashing exists, use respiratory protection if aerosolizing
Hygiene Measures: Wash hands after handling, avoid contact with skin, eyes, clothing
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH (1%): 3.5–4.5
Melting Point: Above 250°C (decomposes)
Boiling Point: Not available (decomposes before boiling)
Solubility: Freely soluble in water
Partition Coefficient: LogP < 1 (hydrophilic)
Vapor Pressure: Negligible
Relative Density: Not available
Flash Point: Not applicable
Flammability: Not classified as flammable
Chemical Stability: Stable under recommended storage conditions
Reactivity: Not reactive under normal handling and storage
Conditions to Avoid: High temperatures, contact with strong oxidizers, acids, direct sunlight
Hazardous Decomposition Products: Nitrogen oxides, bromine, carbon oxides upon heating
Polymerization: Will not occur
Acute Toxicity: Highly potent, LD50 data not fully established, suspected low mg/kg range in laboratory animals
Routes of Entry: Parenteral (clinical), accidental oral/dermal/inhalation
Symptoms of Exposure: Muscle paralysis, respiratory arrest, decreased heart rate, possible cardiac effects
Carcinogenicity: Not classified as carcinogen by IARC, NTP, OSHA
Mutagenicity: No evidence in current data
Reproductive Toxicity: Not established for humans, animal data limited
Other Effects: Serious hazard if misused, monitoring during administration essential
Ecotoxicity: Insufficient direct studies, likely toxic to aquatic organisms at high concentrations
Persistence and Degradability: Not readily biodegradable in environment
Bioaccumulation Potential: Low, hydrophilic structure reduces likelihood
Mobility in Soil: Expected to bind moderately to soil, but risk of leaching present
Other Adverse Effects: Can contribute to pharmaceutical pollution if not disposed of safely
Waste Disposal Methods: Treat as hazardous chemical waste, incinerate in approved facility or follow pharmaceutical hazardous guidelines, do not discharge into sewer or environment
Containers: Triple-rinse empty containers, dispose as regulated hazardous material
Legal Requirements: Dispose in accordance with local, regional, and national regulations, consult hazardous waste professionals if in doubt
UN Number: Not assigned for this compound
Transport Class: Not specifically regulated, treat as hazardous for pharmaceuticals
Packing Group: No data, ship in leak-proof, labeled containers
Proper Shipping Name: Pharmaceutical product, toxic, solid, organic, n.o.s.
Special Precautions: Protect from physical damage, keep separated from incompatible substances, secure documentation during shipment
OSHA Status: Not specifically listed, general hazard management applies for pharmaceuticals
TSCA: Not listed
Regulation (EC) No 1907/2006 (REACH): Not registered due to pharmaceutical exemption
WHMIS Classification: D2A very toxic material (Canada)
Other National/International Regulations: Use restricted to medical professionals, possession and use covered by drug scheduling laws in most countries
Labeling Requirements: Clearly mark with drug name, hazard and handling precautions, emergency contact
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