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Product Name: Ibrutinib
SYNONYMS: PCI-32765, Imbruvica
CAS Number: 936563-96-1
RELEVANT IDENTIFIED USES: Pharmaceutical intermediate, oncology research and treatment
SUPPLIER DETAILS: Pharmaceutical manufacturers, distributors, laboratory supply companies
EMERGENCY CONTACT: Local regulatory authorities, supplier hotlines, poison control centers
GHS Classification: Harmful if swallowed, causes skin and eye irritation, suspected of damaging fertility or the unborn child, may cause damage to organs through prolonged or repeated exposure
GHS Label Elements: Pictograms: Exclamation mark, health hazard
Signal Word: Warning
Hazard Statements: Harmful if swallowed, suspected of causing cancer by inhalation, skin and eye irritant, may cause allergy or asthma symptoms or breathing difficulties if inhaled, possible risk of genetic defects
Precautionary Statements: Avoid breathing dust, fumes, wash hands thoroughly after handling, eat or drink away from the material, wear appropriate gloves, goggles, and protective clothing
Chemical Name: Ibrutinib
Chemical Formula: C25H24N6O2
Molecular Weight: 440.5 g/mol
PURITY: ≥98% (pharmaceutical grade)
IMPURITIES: Trace process-related chemicals and degradation products
ADDITIONAL FORMULATION: May appear in tablet, capsule, or bulk powder forms with excipients depending on commercial product
Inhalation: Move person to fresh air, keep airways open, seek medical attention if symptoms persist, provide oxygen if breathing is difficult
Skin Contact: Remove contaminated clothing, wash skin with soap and water for 15 minutes, consult a physician if irritation develops
Eye Contact: Rinse immediately with water for at least 15 minutes, lift upper and lower eyelids occasionally, seek medical care
Ingestion: Rinse mouth, do not induce vomiting, seek immediate medical attention, never give anything by mouth to an unconscious person
Acute and Delayed Effects: Allergic reactions, respiratory distress, gastrointestinal symptoms
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Media: High pressure water stream
Special Hazards: May form toxic fumes of nitrogen oxides, carbon oxides if combusted
Protective Equipment: Wear self-contained breathing apparatus (SCBA), protective firefighting gear
Firefighting Procedures: Cool fire-exposed containers with water spray, evacuate area if heavy smoke or fumes, ventilate closed spaces
Personal Precautions: Use appropriate personal protective equipment, avoid dust formation, avoid breathing vapors or mist
Environmental Precautions: Prevent entry into sewers, watercourses, or soil, inform authorities in case of large spills
Methods for Cleanup: Sweep up and collect material in a suitable container, clean spill area with water and detergent, ventilate area
Addition: Dispose of collected material as hazardous waste
Handling: Handle in well-ventilated areas, avoid generating dust or aerosols, use personal protective equipment to prevent skin and eye contact, wash hands and face thoroughly after handling, keep containers tightly closed
Storage: Store in original containers, in a dry, cool, well-ventilated area, protect from light and moisture, keep away from food, feed, and incompatible materials, restrict access to authorized personnel only
Engineering Controls: Use fume hood or local exhaust ventilation, maintain negative pressure if working with large quantities, monitor airborne concentrations if possible
Personal Protective Equipment (PPE): Safety goggles, chemical-resistant gloves, lab coats or disposable coveralls, dust mask or respirator suitable for fine particulates or pharmaceutical powders, closed-toe shoes
Hygiene Measures: Do not eat, drink, or smoke in work areas, wash hands before breaks and after handling, remove contaminated clothing before entering eating areas
Occupational Exposure Limits: No established limits for Ibrutinib, handle as a cytotoxic agent with occupational precautions
Appearance: White to off-white crystalline solid or powder
Odor: Odorless
Odor Threshold: Not available
pH: Not available
Melting Point / Freezing Point: 210-215°C
Boiling Point/Range: Not available
Flash Point: Not applicable
Evaporation Rate: Not available
Flammability: Not classified as flammable
Vapor Pressure: Not available
Vapor Density: Not available
Solubility (Water): Practically insoluble
Partition Coefficient (log Kow): Not available
Auto-Ignition Temperature: Not available
Decomposition Temperature: Not available
Viscosity: Not applicable
Chemical Stability: Stable under normal storage and handling conditions
Conditions to Avoid: Exposure to moisture, high temperatures, direct sunlight
Incompatible Materials: Strong oxidizing agents, acidic or basic materials
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide, possible other hazardous substances
Hazardous Reactions: No dangerous reactions under normal conditions, avoid mixing with incompatible chemicals
Routes of Exposure: Inhalation, ingestion, skin contact, eye contact
Acute Toxicity: Harmful if swallowed (toxicity data available from animal studies), serious adverse effects in humans at therapeutic doses
Chronic Toxicity: Reproductive and developmental toxicity, carcinogenic potential (as per preclinical data), risk for organ damage with prolonged exposure
Symptoms of Exposure: Gastrointestinal disturbances, respiratory irritation, skin and eye irritation, dizziness, risk of anemia or bleeding events
Sensitization: Potential for allergic skin or respiratory reactions
Mutagenicity / Carcinogenicity: Reports suggest genotoxic potential, not classified as group 1 carcinogen by IARC
Ecotoxicity: Harmful to aquatic life based on structural alerts and limited bioassay, not expected to bioaccumulate significantly
Persistence and Degradability: Data limited for environmental persistence, chemical structure resists rapid degradation
Bioaccumulative Potential: Expected low based on chemical profile
Mobility in Soil: May persist in soils, limited water solubility reduces mobility
Other Adverse Effects: Avoid uncontrolled release to the environment, risk to aquatic organisms cannot be ruled out
Waste Treatment Methods: Dispose through incineration in accordance with local, regional, and national regulations; consult environmental authorities for proper procedures
Contaminated Packaging: Dispose of containers as hazardous waste, ensure containers are thoroughly cleaned before recycling or disposal
Special Precautions: Prevent entry into water, soil, or municipal waste systems without proper treatment, label as cytotoxic waste where applicable
UN Number: Not assigned
Proper Shipping Name: Ibrutinib, pharmaceutical substance
Transport Hazard Class: Not regulated as a hazardous material
Packing Group: Not applicable
Environmental Hazards: Not classified for transport as environmentally hazardous
Special Precautions for Transport: Prevent spillage, avoid physical damage to containers, secure loads during transportation
Regulatory Status: Prescription medication approved by regulatory health authorities in multiple countries for specific cancer treatments
TSCA (USA): Not listed
OSHA (USA): Handle as hazardous under OSHA regulations for cytotoxic drugs
WHMIS (Canada): Controlled product, Schedule F (prescription pharmaceuticals)
REACH (EU): Exempt as medicinal product; contained use directive applies in manufacturing
Other Regulatory References: Registered with FDA, EMA, local Ministries of Health, subject to labeling, packaging, and safe-handling rules for cytotoxic and oncology drugs
