Product Name: Formoterol Fumarate Anhydrate
Chemical Formula: C42H52N4O8·C4H4O4
Synonyms: Foradil, Oxeze, Formoterol hemifumarate, Formoterol fumarate anhydrous
Manufacturer: [Manufacturer’s Name]
Recommended Use: Pharmaceutical, treatment of asthma and chronic obstructive pulmonary disease (COPD)
Contact Information: [Contact Address/Phone Number]
Emergency Contact: [Emergency Number]
Classification: Respiratory sensitizer, Eye irritant, Skin irritant, Target organ toxicity (repeated exposure)
Signal Word: Warning
Hazard Statements: Causes serious eye irritation, May cause respiratory irritation, May cause allergic skin reaction, May cause organ damage through prolonged or repeated exposure
Pictograms: Exclamation mark, Health hazard
Precautionary Statements: Avoid breathing dust; wash hands thoroughly after handling; avoid release to environment; wear protective gloves/eye protection/face protection; seek medical attention if you feel unwell
Chemical Name: Formoterol Fumarate Anhydrate
CAS Number: 43229-80-7 (Formoterol), 97-67-6 (Fumaric Acid)
EC Number: 256-095-6
Content: Pure compound or as labeled
Impurities: Below safety thresholds for pharmaceuticals, trace solvents, excipients may be present in commercial products
Inhalation: Move person to fresh air, monitor breathing, seek immediate medical attention for difficulty breathing or persistent symptoms
Skin Contact: Remove contaminated clothing, rinse skin thoroughly with water and soap, get medical advice for irritation or allergic reaction
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, continue rinsing, seek medical help if symptoms persist
Ingestion: Rinse mouth, do not induce vomiting, call a poison center or doctor, monitor for any symptoms such as nausea, vomiting, or allergic reaction
Most Important Effects: Breathing difficulty, skin rash, eye irritation
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical, foam
Unsuitable Extinguishing Media: High force water jet
Special Hazards: Emits toxic fumes such as nitrogen oxides, carbon monoxide, carbon dioxide during combustion
Fire Fighting Instructions: Wear full protective suit including self-contained breathing apparatus, keep containers cool with water spray, evacuate area if large fire occurs
Personal Precautions: Avoid dust formation, ventilate area, use personal protective equipment including gloves and goggles, prevent skin and eye contact
Environmental Precautions: Prevent large releases from entering drains, sewers or waterways
Containment and Cleaning: Collect spillage using damp disposable cloths, avoid creating airborne dust, place in proper waste container, wash spill site after material pickup, dispose of according to local regulations
Handling: Minimize dust generation, use with adequate ventilation, wear recommended protection, do not eat or smoke during handling, wash hands thoroughly after working
Storage: Store in tightly closed container, keep in cool and dry place away from light, heat, and incompatible substances such as strong oxidizing agents
Special Requirements: Avoid moisture, store separately from acids and bases, keep away from direct sunlight, observe pharmaceutical storage protocols if applicable
Engineering Controls: Use local exhaust or general ventilation to control airborne concentrations
Exposure Limits: No specific occupational exposure limits set; minimize exposure as much as possible per pharmaceutical industry procedures
Personal Protective Equipment: Chemical-resistant gloves (nitrile or latex), tightly sealed goggles, laboratory coat, respiratory protection for high dust situations
Hygiene Measures: Wash thoroughly after handling, avoid contact with skin, eyes, and clothing, do not ingest or inhale dust, handle in designated areas
Appearance: White to off-white crystalline powder
Odor: Odorless or faint chemical smell
Odor Threshold: Not determined
pH: Not applicable in solid state
Melting Point/Range: 106–108°C (Formoterol base)
Boiling Point/Range: Not specified (decomposes on heating)
Flash Point: Not combustible at typical room temperatures
Evaporation Rate: Not applicable
Flammability: Non-flammable in solid form
Vapor Pressure: Not relevant for solid
Density: Approximately 1.2 g/cm³
Solubility: Slightly soluble in water, soluble in methanol and ethanol
Partition Coefficient (log Pow): Approximately 1.9 (for Formoterol base)
Decomposition Temperature: Above 190°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions, sensitive to light and moisture
Possibility of Hazardous Reactions: No hazardous polymerization expected
Conditions to Avoid: Excess heat, moisture, exposure to light, contact with incompatible substances
Materials to Avoid: Strong acids, strong bases, strong oxidizing agents
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, other toxic fumes under fire conditions
Acute Toxicity: Data limited; oral and inhalation exposure may lead to systemic effects typical of β2-agonists such as tremors, tachycardia, hypokalemia
Skin Corrosion/Irritation: Possible irritant, sensitizer based on structural properties
Serious Eye Damage/Irritation: Causes eye irritation
Respiratory Sensitization: May cause allergic or asthmatic symptoms in sensitive individuals
Carcinogenicity: Not listed by NTP, IARC, OSHA
Mutagenicity: Negative in most standard assays
Reproductive Toxicity: Studies in animals show low risk at therapeutic doses
Chronic Toxicity: May affect heart or nervous system after repeated exposure
Symptoms: Rapid heart rate, muscle tremors, nausea, headache, dizziness, allergic skin reaction
Ecotoxicity: Potential for harmful effects on aquatic organisms due to activity as a β2-agonist pharmacologically active compound
Persistence and Degradability: Not readily biodegradable, may persist in the environment
Bioaccumulation: Low potential for bioaccumulation based on chemical properties
Mobility in Soil: Possible to migrate through soil, especially if spilled in large quantities
Other Adverse Effects: Some concern about trace pharmaceutical contamination in waterways; encourage proper disposal protocols
Waste Disposal Methods: Collect and incinerate waste in compliance with local, regional, national, and international regulations for pharmaceutical waste
Container Disposal: Triple rinse containers, dispose of as pharmaceutical hazardous waste
Precautions for Disposal: Avoid discharge into the environment, do not release into sewers or public water systems, use authorized disposal facilities
UN Number: Not regulated for ground, air, or sea transport under dangerous goods regulations for pharmaceuticals
Proper Shipping Name: Not a hazardous material as per standard transportation guidelines
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Special Precautions: Use original packaging, label clearly for identification, protect from physical damage and moisture during transport
TSCA Status: Not listed on US TSCA inventory as pharmaceutical active ingredient
FDA Status: Approved prescription drug for inhalation use
EU Regulations: Complies with REACH as medicinal product, not subject to registration
OSHA Hazards: Considered hazardous chemical in bulk powder form
Other Regulatory: Complies with appropriate national and international pharmaceutical regulations, requires appropriate labeling and worker protection during handling