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MSDS for Iopamidol

Identification

Product Name: Iopamidol
Chemical Formula: C17H22I3N3O8
Synonyms: Isovue, Niopam, Iopamiron, Ultravist
CAS Number: 62883-00-5
Intended Use: Diagnostic X-ray contrast agent
Manufacturer Details: Contact the specific supplier or manufacturer listed on the product packaging for emergency information or medical advice.
Emergency Contact: Poison control center or local emergency services
Recommended Use: Injectable contrast media for radiographic imaging in healthcare settings

Hazard Identification

GHS Classification: Not classified as hazardous according to GHS standards for the supplied product
Signal Word: None
Hazard Statements: No significant hazards known under normal conditions of use; accidental exposure may cause mild skin or eye irritation
Precautionary Statements: Use appropriate protective measures, avoid contact with eyes/skin
Most Important Hazards: May cause allergic reactions in sensitive individuals, particularly those with iodine sensitivity
Label Elements: None required for end-use injectable form

Composition / Information on Ingredients

Main Ingredient: Iopamidol (Chemical Identity: C17H22I3N3O8) (Content: 630–770 mg/mL depending on formulation)
Purity: Typically >99% as active ingredient
Other Ingredients: Sodium calcium edetate, trometamol, hydrochloric acid, water for injection (percentages depend on manufacturer/formulation strength)
Impurities or Stabilizers: Product is designed for single-use applications under strictly controlled conditions; impurities minimized by pharmaceutical manufacturing standards

First Aid Measures

Inhalation: Remove to fresh air, seek medical attention if breathing difficulty or irritation occurs
Skin Contact: Rinse thoroughly with water, wash with soap, seek medical attention if irritation persists
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy, seek further care for persistent symptoms
Ingestion: Rinse mouth with water, consult a physician, never induce vomiting without medical advice
Acute Symptoms: May cause mild irritation, nausea, rarely hypersensitivity reactions such as hives, throat swelling, or anaphylaxis in predisposed individuals
Special Treatment Needed: Oxygen or Epinephrine administration in case of severe allergic reaction under medical supervision

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, carbon dioxide, foam, or dry chemical—whichever is easiest to access for small laboratory or hospital fires
Special Hazards: Decomposition above 200°C may release hazardous iodine compounds and oxides of carbon and nitrogen
Protective Equipment for Firefighters: Full protective clothing and self-contained breathing apparatus
Specific Firefighting Instructions: Cool containers with water spray from a safe distance to prevent rupture; avoid inhaling fumes
Combustion Products: Carbon oxides, iodine vapors, nitrogen oxides

Accidental Release Measures

Personal Precautions: Wear gloves, eye protection, and lab coat; ensure proper ventilation
Environmental Precautions: Prevent spilled product from entering drains, surface water, or soil
Spill Cleanup Methods: Absorb with inert material such as vermiculite or sand, scoop up and dispose of according to regional regulations
Disposal Tools: Use sealed, designated medical waste containers for all cleanup materials
Large Spill Response: Notify authorities, isolate area, ventilate if possible, use professional cleanup assistance

Handling and Storage

Safe Handling: Use by trained professionals in controlled medical or laboratory settings
Avoid: Direct contact with skin, mucous membranes, and eyes; inhalation of vapors, if aerosolized
Storage Conditions: Keep in tightly closed, original container in temperature-controlled environment (15–30°C)
Incompatibilities: Oxidizing agents, strong acids or bases
Specific Storage Instructions: Protect from light, moisture, and extreme temperatures; do not freeze
Shelf Life: Based on manufacturer’s labeled expiry date

Exposure Controls and Personal Protection

Control Parameters: No occupational exposure limits established for Iopamidol
Engineering Controls: Prepare and administer in well-ventilated area, use local exhaust if available
Personal Protective Equipment: Nitrile or latex gloves, protective safety glasses or goggles, standard laboratory coats or gowns
Hygiene Measures: Wash hands thoroughly after handling, no eating, drinking, or smoking in use areas
Special Protection: Additional respiratory protection for powdered form; not required for ready-to-inject solutions

Physical and Chemical Properties

Appearance: Clear, colorless to slightly yellow solution (commercial injectable preparation)
Odor: Odorless
Boiling Point: Decomposes before boiling
Melting Point: Decomposes before melting
Solubility: Fully miscible in water
Density: Approximately 1.3–1.4 g/cm³ at 20°C
pH: 6.5–7.7 (varies based on formulation)
Viscosity: 2–12 mPa·s (depends on concentration)
Partition Coefficient: logP ≈ -2.1 (indicating hydrophilicity)
Stable under normal conditions: Yes

Stability and Reactivity

Chemical Stability: Stable at recommended storage and use conditions
Decomposition Possibility: Decomposes at elevated temperatures, releasing iodine-containing vapors
Conditions to Avoid: Light, heat, incompatible materials, prolonged exposure to air
Incompatible Materials: Strong oxidizers, reducing agents, acids, or bases
Hazardous Reactions: No hazardous polymerization identified
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, iodine compounds

Toxicological Information

Acute Toxicity: Very low by oral, dermal, or inhalation routes (LD50 oral rat > 6000 mg/kg)
Chronic Toxicity: Not expected with clinical use; repeated high doses in non-clinical studies caused reversible kidney effects
Irritation: Minimal skin, eye, or respiratory system irritation in standard practice
Sensitization: Hypersensitivity, including anaphylaxis, may occur, especially in individuals with history of allergies to contrast media or iodine
Carcinogenicity: No known carcinogenicity as per available data
Mutagenicity: Studies show negative or equivocal results
Reproductive Effects: Not considered teratogenic or associated with birth defects in standard dosing
Other Effects: Clinical use can occasionally cause nausea, headache, itching, rash, or hemodynamic changes

Ecological Information

Environmental Fate: Not readily biodegradable; may persist in water and soil
Aquatic Toxicity: Low toxicity to aquatic organisms (LC50 > 100 mg/L in fish)
Bioaccumulation Potential: Low (logP ≈ -2.1)
Mobility in Soil: High mobility due to hydrophilicity; potential to reach groundwater but unlikely to bioaccumulate
Persistence: Stable in environment, slowly degraded
Special Considerations: Avoid large-scale release to water systems, follow local environmental regulations

Disposal Considerations

Waste Treatment Procedures: Dispose of unused material or contaminated items via approved hazardous or pharmaceutical waste stream
Packaging Disposal: Triple rinse containers if possible, follow sharps/biohazard procedures where applicable
Environmental Impact: Do not discharge to sewers, waterways, or open soil
Disposal Code: Refer to local regulations for assignment; typically non-hazardous pharmaceutical waste

Transport Information

UN Number: Not classified as dangerous goods by UN/ADR, IATA, IMDG
Proper Shipping Name: Not regulated
Transport Hazard Class: None
Packing Group: None
Environmental Hazards: None in packaged form
Special Precautions for User: Avoid breakage and leaks, store upright, protect from sunlight and overheating during transit

Regulatory Information

Inventory Listings: Listed on relevant chemical inventories such as US TSCA (for research use); exempt for pharmaceutical formulations
OSHA Status: Not regulated as hazardous under US OSHA Hazard Communication Standard
FDA Status: Approved prescription-only drug product in the US, EU, and other jurisdictions
WHMIS Status (Canada): Exempt as a drug product
REACH Status (EU): Not classified due to medicinal use
Other Regulations: Subject to prescription, administration, and handling laws in each country
Labeling Requirements: Determined by pharmaceutical and regulatory agencies for finished medical products