© 2026 Sinochem Nanjing Corporation,
All Right Reserved
Product Name: Sunitinib Malate
Synonyms: SU11248 Malate; Sutent
Chemical Formula: C22H27FN4O2 • C4H6O5
Molecular Weight: 532.6 g/mol (base + malate)
CAS Number: 341031-54-7
Intended Use: Research, pharmaceutical development
Manufacturer: [Company information specific to supplier]
Emergency Contact: [Company emergency number]
GHS Classification: Acute toxicity (oral), hazard for specific organs, eye irritation
Signal Word: Danger
Hazard Statements: May cause harm to organs through prolonged or repeated exposure; causes serious eye irritation; may cause nausea, vomiting, and headache on ingestion; potentially carcinogenic
Pictograms: Exclamation mark, health hazard
Precautionary Statements: Avoid breathing dust; wash hands thoroughly after handling; use personal protective equipment as required; avoid contact with skin and eyes; seek medical advice if feeling unwell
Routes of Exposure: Ingestion, inhalation, skin contact, eye contact
Symptoms: Nausea, diarrhea, yellowing of skin (jaundice), eye discomfort, skin rash
Chemical Name: Sunitinib Malate
Percent: More than 97% pure active substance
Components: Sunitinib base, malic acid
Impurities: Trace process-related substances
Hazardous Components: Sunitinib Malate (exposure to higher quantities risks toxicity)
Other Ingredients: None known
Inhalation: Move to fresh air; if symptoms persist, seek medical attention promptly
Skin Contact: Wash immediately with plenty of soap and water; remove contaminated clothing
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses; continue rinsing and seek medical help
Ingestion: Rinse mouth; do not induce vomiting; get medical attention right away
Most Important Symptoms: Abdominal pain, headache, skin eruptions, respiratory discomfort
Advice for Healthcare Providers: Treat symptomatically and monitor vital signs
Suitable Extinguishing Media: Dry chemical, CO2, foam, water spray
Unsuitable Extinguishing Media: Direct water jet
Special Hazards: Combustion releases toxic fumes including nitrogen oxides, carbon monoxide
Protective Equipment: Firefighters wear self-contained breathing apparatus with full protective clothing
Fire Fighting Procedures: Stay upwind; avoid inhaling smoke or fumes; move containers away from fire if possible without risk
Hazardous Combustion Products: Irritating and toxic gases under fire conditions
Personal Precautions: Evacuate unnecessary personnel; avoid skin and eye contact; use personal protective equipment
Environmental Precautions: Prevent release to sewers or waterways; contain spillage
Clean-Up Procedures: Sweep or vacuum spilled material into suitable container for disposal; avoid raising dust; ventilate area
Decontamination: Wash area with water and detergent after cleanup
Disposal: Use marked containers for disposal according to local regulations
Handling: Work in well-ventilated places; minimize dust generation; avoid ingestion, inhalation, and prolonged skin contact; practice good hygiene
Storage: Store in tightly closed containers in cool, dry, ventilated areas; protect against light and moisture; secure from unauthorized access
Incompatible Materials: Strong oxidizers, acids, and bases
Special Precautions: Label containers clearly; keep away from food, drink, and animal feed
Other Info: Restrict access to trained personnel
Engineering Measures: Use local exhaust ventilation or fume hood; maintain low dust levels
Occupational Exposure Limits: No established limits for Sunitinib Malate; minimize exposure
Personal Protective Equipment: Lab coat, nitrile or latex gloves, safety goggles, and, if dust is likely, NIOSH-approved respirator
Hygiene Measures: Wash hands thoroughly after handling; avoid touching face; remove protective equipment before leaving work area
Environmental Controls: Prevent material from entering drains or watercourses
Appearance: Pale yellow to orange powder
Odor: Odorless
Odor Threshold: Not available
pH: Slightly acidic in solution
Melting Point: 230–240°C
Boiling Point: Not available; decomposes before boiling
Solubility: Slightly soluble in water; soluble in DMSO and methanol
Partition Coefficient: logP = ~2.7
Vapor Pressure: Negligible
Relative Density: ~1.4 g/cm3
Chemical Stability: Stable under standard conditions
Reactivity: Inert under normal usage; avoids extreme temperatures
Conditions to Avoid: Exposure to strong light, moisture, excessive heat
Incompatible Materials: Strong acids, strong bases, oxidizers
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide and carbon dioxide upon combustion
Polymerization: Will not occur
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Oral LD50 (rat): 400–800 mg/kg
Chronic Toxicity: Organ toxicity with sustained exposure; developmental effects seen in animal models
Carcinogenicity: Not classified by IARC or NTP, evidence of tumor growth in preclinical models
Mutagenicity: Positive in vitro tests for genetic mutations; negative or inconclusive in vivo data
Sensitization: May cause allergic reactions on skin
Target Organs: Liver, gastrointestinal tract, bone marrow
Symptoms: Headache, fatigue, gastrointestinal upset, potential jaundice, leukopenia, skin reactions
Ecotoxicity: Toxic to aquatic organisms at low concentrations
Persistence and Degradability: Not readily biodegradable; stable in aquatic and soil environments
Bioaccumulation Potential: Moderate based on partition coefficient
Mobility in Soil: Low mobility; tends to bind to soil particles
Other Adverse Effects: Risk of long-term effects in aquatic life; minimize environmental release
Disposal Methods: Collect under controlled conditions; transfer to licensed chemical waste facility;
Container Disposal: Dispose of packaging with residual material as hazardous waste
Special Precautions: Do not release into drains, surface water, or soil
Waste Codes: Follow local, state, and federal regulations for hazardous pharmaceutical compounds
Recommended Practices: Use incineration or other approved destruction technology
UN Number: Not classified for transport under current UN model regulations
Proper Shipping Name: Sunitinib Malate
Transport Hazard Class: Not regulated as dangerous goods by IATA, IMDG, or USDOT
Packing Group: Not assigned
Special Precautions: Package securely to avoid breakage; segregate from incompatible materials
Environmental Hazards: Prevent bulk release; not a marine pollutant but limit exposure to aquatic environments
TSCA Status: This substance may not be listed under TSCA
OSHA Hazard Status: Considered hazardous
REACH Status: Not registered for commercial use within the EU
US SARA Title III: Not listed as an extremely hazardous substance
California Proposition 65: Not listed
Other Regulations: Pharmaceutical active ingredient; subject to specific handling and reporting in many jurisdictions; follow national requirements
