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Product Name: Sunitinib Malate
Synonyms: Sutent, SU11248
Chemical Formula: C22H27FN4O2 • C4H6O5
CAS Number: 341031-54-7
Intended Use: Pharmaceutical intermediate for cancer treatment, primarily used in research and oncology settings
Manufacturer’s Details: Pfizer Inc., or relevant local supplier
Emergency Contact: Local Poison Control Center or manufacturer’s 24-hour helpline; details provided on packaging and manufacturer website
Recommended Restrictions: For research and medical use only; not designated for general public or veterinary use
GHS Classification: Acute toxicity category 4 (oral), skin irritation category 2, eye irritation category 2A, reproductive toxicity category 1B
Label Elements: Signal word: Danger. Hazard pictograms: Exclamation mark and health hazard symbols
Hazard Statements: Harmful if swallowed, causes skin and eye irritation, suspected of damaging fertility or the unborn child
Precautionary Statements: Avoid direct contact with skin, wash hands thoroughly after handling, use only outdoors or in a well-ventilated area, wear protective clothing
Routes of Exposure: Ingestion, inhalation, dermal contact, eye contact
Target Organs: Liver, kidney, gastrointestinal tract, reproductive organs
Chronic Effects: Prolonged exposure might result in reproductive harm, liver toxicity, potential carcinogenic effects. Laboratory studies suggest multi-organ impact in animals under high dose conditions, so limiting occupational exposure is key.
Component Name: Sunitinib Malate
Concentration: >98% pure material
Chemical Family: Tyrosine kinase inhibitor
Impurities and Stabilizing Additives: Trace organic solvents, unreacted precursors possible at very low ppm levels as per synthesis route
Inhalation: Remove person to fresh air immediately. Seek medical attention if respiratory symptoms develop or persist (coughing, shortness of breath, chest discomfort). Oxygen or respiratory support if breathing becomes difficult. Observe for delayed symptoms.
Skin Contact: Remove contaminated clothing, wash skin with soap and large amounts of water for 15 minutes minimum. Medical attention is necessary for irritation, rash, or persistent redness.
Eye Contact: Rinse cautiously with water for at least 15 minutes. Remove contact lenses if present. Continue rinsing and seek immediate medical attention if redness, pain, or visual changes develop.
Ingestion: Rinse mouth with water. Do not induce vomiting. Seek urgent medical advice. Never give anything by mouth to an unconscious or convulsing person.
Medical Notes: Symptomatic and supportive care is recommended. Consider consultation with poison control experts in case of accidental exposure. Monitor liver and renal function if large amount is absorbed or ingested.
Suitable Extinguishing Media: Dry chemical, CO₂, foam, or water spray. Select extinguishing agent suitable for surrounding fire.
Specific Hazards: Combustion produces toxic fumes including nitrogen oxides, carbon monoxide, carbon dioxide, hydrogen fluoride, possible sulfur oxides.
Protective Equipment: Firefighters require self-contained breathing apparatus and full protective gear, since smoke and decomposition products pose significant toxic risks.
Special Procedures: Contain runoff, prevent contamination of drains and surface waters. Cool exposed containers with water spray from a safe distance.
Personal Precautions: Use respiratory protection, impervious gloves, chemical goggles, and disposable coveralls to prevent contamination. Only trained personnel should handle cleanup.
Environmental Precautions: Avoid discharge to drains, surface water, or soil. Minimize spread of contamination. Notify authorities if large spills occur.
Clean-Up Methods: Carefully collect spillage with absorbent material (activated charcoal or spill pads), place in tightly closed containers for disposal. Wash area with detergent and water while preventing runoff.
Decontamination: Rinse all tools and protective gear before reuse. Dispose of cleaning materials as hazardous waste according to local regulations.
Handling: Use engineering controls such as fume hoods, containment isolators, or biosafety cabinets. Wear personal protective equipment (disposable nitrile gloves, lab coat, safety glasses). Strictly avoid ingestion, inhalation, and skin contact. Do not eat, drink, or smoke in areas where active pharmaceutical ingredients are processed.
Storage: Store in tightly sealed original containers, in a cool, dry, well-ventilated area. Protect from direct sunlight, moisture, and incompatible chemicals. Keep away from foodstuffs and non-laboratory personnel.
Incompatibilities: Strong oxidizers, strong acids, and strong bases can cause decomposition or dangerous reactions.
Occupational Exposure Limits: No established U.S. OSHA, NIOSH, or ACGIH exposure limits. Internal hazard assessments suggest strict control to minimize employee exposure (target OEL typically <1 µg/m³ for potent drugs).
Engineering Controls: Biosafety cabinets, powder containment hoods, and HEPA-filtered exhaust scrubbers
Personal Protective Equipment (PPE): Disposable nitrile gloves, chemical splash goggles, laboratory coat with full closure, and, for larger quantities or dust generation, NIOSH-approved respiratory protection (P3 anti-particulate or similarly rated filter).
Hygiene Measures: Wash hands thoroughly before breaks and after work. Remove contaminated clothing immediately.
Environmental Exposure Controls: Prevent release to surface or groundwater through proper containment and waste management. Monitor emissions from production and handling facilities routinely.
Appearance: Pale yellow to orange powder or crystalline solid
Odor: Odorless or faint chemical odor
Molecular Weight: 398.5 g/mol (free base), 532.6 g/mol (malate salt)
Melting Point: 181–186°C (varies with salt form)
Solubility: Soluble in DMSO, ethanol, poorly soluble in water
pH: Solutions in water are weakly acidic
Partition Coefficient (log Kow): 2.4 (approximate, dependent on pH)
Vapor Pressure: Negligible at room temperature
Boiling Point: Decomposes before boiling
Flash Point: Not applicable (decomposes)
Stability: Chemically stable under recommended storage conditions; avoid direct sunlight and high humidity for optimal shelf-life.
Conditions to Avoid: Open flames, elevated temperatures, direct UV light, excessive moisture
Incompatible Materials: Strong acids, strong bases, strong oxidizers
Hazardous Decomposition Products: Toxic fumes including oxides of nitrogen, carbon monoxide, carbon dioxide, hydrogen fluoride may form under fire or thermal decomposition.
Polymerization: Hazardous polymerization does not occur under normal conditions.
Routes of Exposure: Eye, skin, inhalation, ingestion
Acute Toxicity: LD50 (oral, rat): approximately 500 mg/kg (malate salt); no human LD50 data available
Skin and Eye Irritation: Moderate irritation possible based on structurally similar compounds; may cause redness, pain, swelling
Carcinogenicity: Not listed by IARC, NTP, or OSHA as a human carcinogen, though antineoplastic drugs have shown tumorigenic effects in animal testing at high doses
Reproductive Toxicity: Animal studies showed fetal organ malformations, decreased fertility at high doses
Other Effects: Chronic exposure can impact liver, kidney, and hematologic systems; possible gastrointestinal upset, mucosal irritation, or systemic toxicity.
Sensitization: No evidence in animal studies, but caution due to potential for class effects.
Ecotoxicity: Very toxic to aquatic life at low concentrations, long-lasting effects expected. Laboratory data indicate acute toxicity in fish and invertebrates at concentrations below 1 mg/L.
Persistence and Degradability: Not rapidly biodegradable; chemical stability in water demonstrates potential for persistence in natural environments.
Bioaccumulative Potential: Estimated log Kow suggests moderate bioaccumulation; risk assessment ongoing.
Mobility in Soil: Low mobility predicted due to poor water solubility; may bind to particulate matter.
Other Adverse Effects: No significant ozone depletion or photochemical hazard expected from use at laboratory or clinical scale.
Disposal Methods: Treat as hazardous pharmaceutical waste. Incinerate in approved facility. Do not dispose via sewer or household trash.
Packaging Disposal: Empty containers and contaminated packaging require triple-rinsing before incineration or disposal as hazardous waste.
Environmental Precautions: Prevent release to air or water. Follow local, state, and federal guidelines. Document all quantities and methods used for auditing and regulatory compliance.
Special Instructions: Consigned waste should go to licensed contractors specializing in pharmaceutical or cytotoxic waste management.
UN Number: Not allocated for sunitinib malate in generic transport; may require UN 1851 (pharmaceutical products, solid, toxic) if shipped in bulk.
Proper Shipping Name: Medicinal product, solid, toxic n.o.s. (contains sunitinib)
Transport Hazard Class: 6.1 Toxic substances
Packing Group: III
Marine Pollutant: Yes, based on ecotoxicity
Special Precautions: Use original labeling and tamper-proof containers. Comply with IATA/ICAO, IMDG, DOT, and ADR requirements.
Reportable Quantity: None assigned for sunitinib, though local regulations can vary.
U.S. Regulatory Status: Investigational or prescription-only under federal drug schedules, not classified as a controlled substance.
OSHA Status: Not specifically regulated as a hazardous chemical, but OSHA Right-to-Know mandates provision of hazard information.
EPCRA/SARA: Not subject to specific reporting thresholds but may be listed due to persistence and toxicity.
REACH/CLP (EU): Registered substance for specific uses, classified as toxic to reproduction (category 1B)
WHMIS (Canada): Notified under requirements for toxic and hazardous substances.
Other: Transport, handling, and environmental emissions regulated under local occupational exposure and environmental safety laws. Always consult up-to-date global and local guidelines for any new registration or import of active pharmaceutical ingredients.
