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Substance Name: Iopromide
Chemical Formula: C18H24I3N3O8
Synonyms: Ultravist, Iopromide Injection
Intended Use: Radiographic contrast media for X-ray imaging processes
Manufacturer Address: Bayer AG, Leverkusen, Germany
Emergency Telephone: +49 214 30-99300
Product Code: Ultravist Series
UN Number: Not regulated
Contact Person: Product Safety Office
Recommended Use: Only under medical supervision for diagnostic imaging
GHS Classification: Not classified as hazardous according to GHS
Physical Hazards: May cause mild irritation to skin and eyes
Health Hazards: Possible allergic reactions, nausea, headache, vomiting, hypotension or in rare cases, severe anaphylactoid responses
Environmental Hazards: May pose some risk if released in large quantities
Label Elements: No pictogram required, not considered hazardous
Signal Word: None
Precautionary Statements: Avoid unnecessary exposure; medical use only
Hazard Statements: Practitioners should watch for allergic or idiosyncratic reaction in patients
Chemical Name: Iopromide
CAS Number: 73334-07-3
Concentration: Typically 76-370 mg iodine/mL, dissolved in water
Other Components: Water for injection, trace stabilizers, buffering agents, and possibly inactive excipients
Purity: Pharmaceutical grade, as required for injection
Impurities: Meets pharmacopeial standards, impurities are controlled below thresholds for injectables
Inhalation: Unlikely route; move to fresh air, provide oxygen if breathing difficulties appear
Skin Contact: Wash affected area thoroughly with soap and water, remove contaminated clothing
Eye Contact: Rinse with plenty of water for several minutes, seek medical advice if irritation persists
Ingestion: Give water to drink if conscious, do not induce vomiting, seek medical attention immediately
Most Important Symptoms: Watch for signs of anaphylactic shock, allergic symptoms, respiratory distress, or cardiovascular instability in exposed individuals
Advice for Physicians: Patients require monitoring for hypersensitivity; treat symptoms supportively
Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide
Unsuitable Extinguishing Media: None known for this product
Hazards from Combustion Products: May produce toxic fumes including iodine vapors, nitrogen oxides, and carbon monoxide
Firefighting Instructions: Contain fire water and prevent runoff; approach upwind
Special Protective Equipment: Firefighters should wear self-contained breathing apparatus and protective clothing
Explosion Risk: Not combustible, does not pose explosion risk in fluid form
Thermal Decomposition: Decomposition results in release of harmful gases if temperature is high enough
Personal Precautions: Use gloves and eye protection, prevent contact with skin and eyes
Environmental Precautions: Prevent leakage into sewers, surface water, or soil
Cleanup Methods: Absorb spill with inert material such as sand or universal binder; place waste in suitable containers for disposal
Methods for Containment: Dike and soak up large spills to limit spread; ventilate area
Reporting: Follow local environmental reporting guidelines for chemical spills, especially for large releases
Special Procedures: Avoid direct handling of contaminated material; use tools that limit risk of splashing
Handling Guidance: Use only in medical facilities by trained staff; avoid splashes, rapid temperature shifts, or direct skin contact
Storage Conditions: Store at controlled room temperature, usually 15-30°C (59-86°F); keep containers tightly closed
Incompatible Materials: Avoid storing with strong oxidizers, acids, or bases
Requirements for Storage: Keep away from sunlight, heat sources, and moisture
Advice on Equipment: Use equipment compatible with pharmaceutical liquids to prevent contamination
General Hygiene: Wash hands after use; do not eat, drink, or smoke while handling
Exposure Limits: No occupational exposure limits established for Iopromide
Engineering Controls: Use well-ventilated areas, fume hoods for preparation of large volumes
Respiratory Protection: Usually not required, unless aerosol or mists generated
Skin Protection: Protective gloves recommended
Eye/Face Protection: Safety goggles or face shield needed when handling bulk material
General Protective Measures: Lab coats recommended, emergency shower and eyewash accessible
Environmental Protection: Limit release to water; prevent bulk solutions from entering drains
Appearance: Clear to faintly yellowish solution
Odor: Nearly odorless
pH: Approximately 7.0 (varies by formulation)
Boiling Point: Not defined for solution; water-based
Melting Point: N/A for injectable liquid
Density: Typically 1.34–1.42 g/cm³ depending on iodine concentration
Solubility: Completely miscible with water
Viscosity: Increases with iodine content
Vapor Pressure: Low
Evaporation Rate: Not volatile under normal storage
Partition Coefficient n-octanol/water: Very low, highly water-soluble
Flammability: Not flammable
Chemical Stability: Stable under recommended storage and handling conditions
Conditions to Avoid: Protect from excessive heat, direct sunlight, and freezing
Materials to Avoid: Avoid strong acids, strong bases, oxidizing agents
Hazardous Decomposition Products: May produce toxic fumes under fire, such as iodine, hydrogen iodide, and oxides of nitrogen or carbon
Polymerization: No hazardous polymerization expected
Reactivity Profile: No specific risks identified during normal use and storage
Routes of Exposure: Mainly intravenous, accidental inhalation, skin and eye contact during handling are possible
Acute Toxicity: Low toxicity in animal studies by oral, dermal, and inhalation routes
Chronic Toxicity: No evidence for chronic health effects from occupational exposure
Irritation: Mild irritation possible after skin or eye exposure
Sensitization: May cause allergic reactions in sensitive individuals following exposure
Reproductive and Developmental Toxicity: No evidence in standard testing
Carcinogenicity: Based on data, not considered a carcinogen by IARC, NTP, ACGIH, or OSHA
Target Organs: No target organ effects expected with proper use; observe caution in persons with impaired renal function
Ecotoxicity: Limited aquatic toxicity; not expected to bioaccumulate
Persistence and Degradability: Moderately persistent, stable in water
Bioaccumulation: Not likely, due to high water solubility and low octanol/water partition coefficient
Mobility in Soil: Highly mobile in aqueous environments
Other Adverse Effects: Trace release from hospital use may occur, but no significant environmental risk expected; encourage best practice handling to minimize unnecessary release
Waste Disposal Methods: Collect bulk or unused material in appropriate chemical waste containers for professional disposal
Disposal of Containers: Rinse and dispose of vials/bottles as per regulations, avoid re-use for any purpose
Regulations: Follow country, state, and local pharmaceutical waste procedures
Incineration: High-temperature incineration possible, observe requirements for halogenated compounds
Environmental Warning: Prevent large volumes from entering water courses, sewers, or soil
UN Number: Not regulated for transport
Proper Shipping Name: Not classified as dangerous for transport
Hazard Class: Not applicable
Packing Group: Not applicable
Label: Not required for ground, air, or sea transport
Special Precautions: Store upright during transit, protect from extreme temperature; maintain sealed in original packaging
Emergency Response: Spillages during transport should be contained and cleaned up as described above
International Inventories: Listed in medical and pharmaceutical regulatory agencies worldwide
OSHA Status: Not hazardous per OSHA Hazard Communication
TSCA Status: Exempt as pharmaceutical
REACH Registration: Not required for finished pharmaceutical products
Labeling Requirements: Pharmaceutical labeling as per approved drug product guidelines
Other Regulations: Product intended only for medicinal use, subject to prescription controls, and must be handled according to current good manufacturing and distribution practices
Risk Phrases: Not considered hazardous, no R/S or H/P phrases required
Additional Information: Approvals for use, handling, storage, and disposal governed by health authority regulations in each jurisdiction
