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Product Name: Oseltamivir Phosphate
Chemical Name: Ethyl (3R,4R,5S)-4-acetylamino-5-amino-3-(1-ethylpropoxy)cyclohex-1-enecarboxylate phosphate
CAS Number: 204255-11-8
Intended Use: Pharmaceutical compound for influenza treatment
Manufacture/Supplier Details: Seek details from supplier documentation or label
Emergency Contact: Local poison control or medical professional
Classification: Not classified as hazardous under GHS for consumer quantities, but large-scale exposure carries risks
Health Hazards: May cause mild eye irritation, skin irritation, or allergic reaction in some individuals. Significant ingestion or inhalation during industrial production can lead to gastrointestinal disturbances such as nausea or vomiting.
Physical Hazards: Not flammable, but thermal decomposition may release irritating gases
Environmental Hazards: Releases in large quantity can potentially impact aquatic environments due to antibiotic properties
Ingredient: Oseltamivir Phosphate
Concentration: Greater than 90% (formulation-dependent for finished products)
Impurities: Trace synthetic process byproducts, handled in accordance with regulatory guidelines
Excipient Information: Finished drug may include lactose, starch, or coloring agents
Inhalation: Move to fresh air, seek medical attention if symptoms develop including coughing, dizziness, or shortness of breath
Skin Contact: Wash area with soap and water, remove contaminated clothing. Monitor for signs of redness, swelling, or rash
Eye Contact: Rinse with water for at least 15 minutes. If irritation persists or vision blurs, consult a healthcare professional
Ingestion: Do not induce vomiting; give small amounts of water to conscious individuals, seek medical help without delay
Note to Physicians: Symptomatic treatment, monitor for allergic reactions or ingestion-related effects, supportive care as needed
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Specific Hazards: Combustion will generate carbon monoxide, nitrogen oxides, and phosphorus oxides
Protective Equipment: Firefighters should wear self-contained breathing apparatus and protective clothing
Fire-Fighting Procedures: Utilize methods minimizing runoff into drains, isolate area if possible. Use water spray to cool exposed containers
Personal Precautions: Avoid breathing dust, ventilate area, use personal protective gear (gloves, lab coat, mask)
Environmental Precautions: Prevent entry to waterways, sewers, or soil
Spill Response: Collect solid or powder material with appropriate tools (e.g., HEPA-filtered vacuum, wet wipe), place in sealed container for disposal. Wash area with detergent and water
Cleanup Procedures: Dispose of surface decontamination materials according to local hazard waste laws
Handling: Avoid dust creation and inhalation, use engineering controls (fume hoods, local exhaust) when possible, wash hands before eating
Storage: Store in a tightly sealed original container at controlled temperature, typically 2–25°C, away from light, moisture, and incompatible materials like powerful oxidizers
Specific Issues: Keep separate from food, beverages, and incompatible chemicals; prevent container damage
Exposure Limits: No established occupational exposure limit, use good industrial hygiene practice
Engineering Controls: Use adequate local ventilation or fume hood, especially for bulk manipulation
Personal Protective Equipment: Nitrile or latex gloves, chemical safety goggles, laboratory coat or apron
Respiratory Protection: Use NIOSH-approved dust mask or respirator if dust begins to form in air
Hygiene Measures: No eating or drinking in work area, wash hands and exposed skin thoroughly after handling
Appearance: White to off-white crystalline powder
Odor: Odorless or slightly medicinal
pH (1% in water): ~4–6
Melting Point: Approximately 180–190°C
Solubility: Moderately soluble in water, very slightly soluble in organic solvents
Boiling Point: Decomposes before boiling
Vapor Pressure: Not applicable
Density: About 1.3–1.5 g/cm³
Partition Coefficient (log P): -1.2 to -2 (high hydrophilicity)
Other Notable Properties: Stable at room temperature, low volatility
Chemical Stability: Stable under recommended conditions, sensitive to moisture and strong oxidizers
Reactivity: Not reactive with most materials, but avoids acidic or oxidative environments
Hazardous Decomposition Products: Fumes of carbon monoxide, nitrogen oxides, and phosphorus oxides can form at high temperatures
Polymerization: Not known to occur
Acute Toxicity: Low to moderate based on animal studies; LD50 (oral, rat) estimated >2000 mg/kg
Irritation: Mild eye and skin irritant in laboratory tests
Sensitization: Possible in hypersensitive individuals
Chronic Effects: No evidence of carcinogenicity or mutagenicity in standard screening at therapeutic levels
Target Organs: High concentrations may affect gastrointestinal tract, rare allergic reactions reported
Other Information: Pharmaceutical formulation safety established for intended patient use
Aquatic Toxicity: Low reported toxicity to fish and aquatic invertebrates, but persistent residues can contribute to antibiotic resistance
Bioaccumulation: Low potential due to hydrophilicity
Degradability: Partially biodegradable in soil and water
Soil Mobility: Moderate
Other Concerns: Effluent emissions from pharmaceutical plants may introduce low levels in surface waters
Waste Handling: Do not dispose of with regular waste or down the drain
Disposal Method: Incinerate in approved facility or follow local hazardous pharmaceutical waste guidelines
Container Disposal: Rinse and triple-wash empty containers, then puncture and send to permitted landfill or hazardous waste incinerator
Environmental Precaution: Prevent bulk drug residues from entering soils, waterways, or sewage systems
UN Number: Not regulated for transport
Proper Shipping Name: Not classified for transport as dangerous goods
Packaging Group: Not applicable
Hazard Class: Not applicable
Labeling Requirements: Standard labeling for pharmaceutical products; not a hazardous chemical in transport legislation
Special Precautions: Protect package from damage and extreme temperatures during shipping
Transportation Mode Compatibility: Air, sea, road, and rail allowed under general pharmaceutical cargo conditions
International Inventories: Listed on relevant medical substance registries where approved for use
OSHA Status: Not specifically regulated as hazardous in workplace standards
TSCA: Exempt under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for pharmaceutical use
SARA Title III: Not listed as a hazardous substance under SARA Section 302/304/313
EU Classification: Not assigned mandatory hazard classes, monitor for updates to REACH conformance
WHMIS: Non-controlled product in Canada for consumer quantities
Additional Notes: Handling and disposal governed by local public health, occupational safety, and environmental protection laws wherever dispensed or compounded
