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Product Name: Eltrombopag Olamine
Chemical Formula: C29H28N6O5 • C2H7NO
Synonyms: Eltrombopag dimethanolamine salt, 3'-{2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxybiphenyl-3-carboxylic acid, Olamine salt
Recommended Uses: Pharmaceutical intermediate, API for thrombocytopenia
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Emergency Phone: [Insert phone number, standardized for ERs]
Email Contact: [Regulatory contact preferred]
Classification: Acute toxicity (oral, inhalation, dermal), Specific target organ toxicity, Category 3
GHS Label Elements: Skull and crossbones for acute toxicity, health hazard pictogram for target organ effects
Signal Word: Danger
Hazard Statements: Harmful if inhaled or swallowed, May damage liver, May cause respiratory irritation
Precautionary Statements: Wear protective gloves and clothing, Avoid breathing dust or vapors, Handle in a fume hood
Target Organs: Liver, blood, upper respiratory tract
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Chemical Identity: Eltrombopag Olamine
CAS Number: 496775-61-2
EC Number: Not assigned
Concentration: >98% (API grade)
Impurities: Residual solvents, byproducts <1% (full certificate of analysis provides further details)
Inhalation: Remove from exposure area to fresh air. If symptoms develop, seek medical attention. Provide oxygen if breathing is difficult.
Skin Contact: Wash thoroughly with soap and water for at least 15 minutes. Remove contaminated clothing.
Eye Contact: Rinse immediately with plenty of water for 15 minutes, keeping eyelids apart. Seek ophthalmologic advice.
Ingestion: Rinse mouth with water, do not induce vomiting. Call poison center or physician immediately.
Most Important Symptoms: Nausea, headache, respiratory distress, skin rash, hepatotoxicity.
Immediate Medical Attention: Required for any significant exposure or persistent symptom.
Suitable Extinguishing Media: Water spray, dry powder, carbon dioxide, foam
Specific Hazards: Emits toxic fumes of nitrogen oxides, carbon monoxide, and sulfur oxides under fire conditions
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing
Explosion Hazard: Dust can form an explosive mixture with air
Special Procedures: Evacuate area, use water spray to cool unopened containers, avoid breathing decomposition products
Personal Precautions: Prevent contact with skin, eyes, and clothing. Use NIOSH-approved respirator, chemical-resistant gloves, safety goggles.
Environmental Precautions: Prevent spill entering sewer or waterways. Alert environmental authorities if significant spillage occurs.
Clean-Up Methods: Sweep up without creating dust, place in suitable closed containers for disposal. Ventilate area and thoroughly clean contaminated surfaces with appropriate detergent.
Handling: Only trained personnel should handle the material inside a certified fume hood or containment device. Avoid dust formation and direct contact.
Storage Conditions: Store in a tightly closed container, in a cool, dry, and well-ventilated area. Protect from light, moisture, and incompatible materials such as acids or oxidizers.
Special Precautions: Label containers clearly. Access limited to trained staff. Keep away from food and animal feed.
Engineering Controls: Local exhaust, chemical fume hood, glovebox where possible
Occupational Exposure Limits: No established OSHA/ACGIH limits; minimize exposure as a precaution
Personal Protective Equipment: Nitrile gloves, lab coat, face shield, splash goggles, and NIOSH-approved respirator
Hygiene Measures: Wash hands thoroughly after handling. Do not eat, drink, or smoke in working area.
Environmental Exposure Controls: Use closed systems to avoid emissions, with appropriate HEPA filtration.
Appearance: Pale yellow to brown crystalline powder
Molecular Weight: 564.64 g/mol (free acid: 442.47, with olamine)
Melting Point: 211 - 217°C
Solubility: Slightly soluble in water, soluble in DMSO and methanol
pH: Not available for solid substance
Odor: Odorless
Boiling Point: Not applicable (decomposes)
Vapor Pressure: Negligible at ambient temperature
Flash Point: Not determined
Partition Coefficient (log P): Not experimentally available, estimated logP = 2.7
Density: Not determined; use standard solid division containers.
Chemical Stability: Stable at room temperature in closed containers, protected from light
Conditions to Avoid: Exposure to air, moisture, heat, flames, and sunlight
Incompatible Materials: Strong acids, strong oxidizers
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide, sulfur oxides
Polymerization: Will not occur under recommended storage and handling.
Possible Acute Effects: Toxic if swallowed, inhaled, or absorbed through skin
Possible Chronic Effects: Evidence of hepatotoxicity, myelosuppression, and reproductive effects from high doses
Carcinogenicity: Not listed by IARC, NTP, or OSHA
Mutagenicity Data: No evidence in standard Ames test, limited animal studies
Reproductive Toxicity: Animal studies suggest possible reproductive impacts at high dose
Symptoms of Exposure: Nausea, vomiting, headache, upper respiratory irritation, hepatic enzyme elevation.
Acute Aquatic Toxicity: No measured data, structurally related substances are toxic to aquatic invertebrates at low concentrations
Persistence and Degradability: Not readily biodegradable, may persist in environment
Bioaccumulation Potential: Moderate, based on logP and chemical structure
Mobility in Soil: Slight, given limited solubility and tendency to bind soil organic matter
Other Adverse Effects: Harmful to aquatic organisms and may cause long-term adverse effects
Waste Disposal: Treat as hazardous pharmaceutical waste. Collect in sealed, labeled containers. Incinerate at licensed facility.
Contaminated Packaging: Dispose of as hazardous waste. Clean thoroughly before recycling or reuse.
Regulatory Guidance: Follow local, national, and international regulations for disposal of API chemicals.
UN Number: Not regulated under UN Model Regulations
Proper Shipping Name: Not classified as dangerous for transport under ADR, IATA, or IMDG
Packing Group: Not applicable
Hazard Class: Not hazardous for transport
Special Precautions: Avoid extreme temperatures and exposure to moisture during transit
Transport Label: Follow national guidelines for shipping pharmaceuticals
Documentation: SDS and approval from responsible person must be included with shipment
OSHA Hazard Communication Standard: Subject to hazard communication (API, laboratory chemical)
TSCA Inventory: Not listed for pharmaceutical use
EU Regulations: Not classified as hazardous under Regulation (EC) No 1272/2008 but subject to REACH registration for bulk transport
Other Regulations: Subject to local, state, or national workplace safety, pharmaceutical control, and environmental protection laws
Label Requirements: Chemical name, hazard warnings, emergency contact, expiry date, storage recommendations
