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Material Safety Data Sheet: Formoterol Fumarate Anhydrate

Identification

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]

Hazard Identification

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

Composition / Information on Ingredients

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

First Aid Measures

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

Fire-Fighting Measures

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

Accidental Release Measures

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 and Storage

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

Exposure Controls and Personal Protection

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

Physical and Chemical Properties

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

Stability and Reactivity

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

Toxicological Information

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

Ecological Information

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

Disposal Considerations

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

Transport Information

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

Regulatory Information

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