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Material Safety Data Sheet: Ipratropium Bromide Monohydrate

1. Identification

Product Name: Ipratropium Bromide Monohydrate
CAS Number: 22254-24-6
Synonyms: 8-Azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate
Recommended Use: Pharmaceutical ingredient, bronchodilator
Supplier Details: Name, address, and phone of supplier or manufacturer
Emergency Contact Number: Supplier or national emergency line

2. Hazard Identification

Classification: Not classified as hazardous under GHS
Signal Word: None
Hazard Statements: May cause respiratory irritation, eye irritation, or skin irritation with contact
Pictograms: None required
Precautionary Statements: Avoid inhalation, contact with skin, and eye exposure
Health Hazards: Possible allergic reactions or bronchospasm in sensitive individuals
Environmental Hazards: No classified environmental hazard but prudent handling required

3. Composition / Information on Ingredients

Chemical Name: Ipratropium Bromide Monohydrate
Concentration: 100%
Ingredient CAS Number: 22254-24-6
Molecular Formula: C20H30BrNO3.H2O
Molecular Weight: 430.37 g/mol (monohydrate form)

4. First Aid Measures

Inhalation: Move person to fresh air and keep comfortable, seek medical attention if symptoms persist
Skin Contact: Remove contaminated clothing, wash skin thoroughly with soap and water, seek medical help if irritation develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present, medical attention if irritation persists
Ingestion: Rinse mouth, do not induce vomiting, seek immediate medical attention
Most Important Symptoms: Mild mucous membrane or respiratory irritation, contact dermal redness, potential allergic reaction

5. Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, carbon dioxide, water spray, foam
Unsuitable Extinguishing Media: High-pressure water jet (spreading risk)
Specific Hazards: Thermal decomposition may generate toxic fumes (carbon oxides, bromine compounds, nitrogen oxides)
Protective Equipment for Firefighters: Self-contained breathing apparatus, full protective gear
Special Precautions: Evacuate area, prevent runoff from entering drains or watercourses

6. Accidental Release Measures

Personal Precautions: Avoid dust formation, ventilate area, use appropriate personal protective equipment (PPE)
Environmental Precautions: Prevent entry into sewers, watercourses, or soil
Methods for Cleanup: Collect spillage with authorized tools, transfer to suitable container for disposal, wash spill site after material pickup
Disposal: Dispose according to local, regional, or national regulations

7. Handling and Storage

Precautions During Handling: Prevent formation of dust, avoid inhalation and prolonged direct contact, use only in well-ventilated areas
Safe Storage Conditions: Store tightly closed in cool, dry, well-ventilated area, away from light, moisture, incompatible materials (like strong oxidizers)
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Storage Temperature: Room temperature (15–25°C)

8. Exposure Controls and Personal Protection

Exposure Limits: No occupational exposure limits established
Engineering Controls: Local exhaust ventilation or other engineering controls to maintain airborne concentrations below recommended exposure limits
Personal Protective Equipment: Safety goggles, chemical-resistant gloves, lab coat, dust mask or respirator (if dust formation possible)
Hygiene Measures: Wash hands after handling, do not eat or smoke when handling material, remove contaminated clothing

9. Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
pH (1% solution): 3.0 to 5.0
Melting Point: 202–204°C (decomposition)
Boiling Point: Not applicable (decomposes)
Solubility: Freely soluble in water, practically insoluble in chloroform and ether
Partition Coefficient (log Kow): Not determined
Vapor Pressure: Not applicable
Relative Density: Not determined
Flash Point: Not determined
Explosive Properties: Not explosive
Oxidizing Properties: Not oxidizing

10. Stability and Reactivity

Chemical Stability: Stable under recommended handling and storage conditions
Reactivity: No hazardous reactions if stored and handled properly
Conditions to Avoid: Moisture, excessive heat, direct sunlight, incompatible materials
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen bromide
Polymerization: Does not occur

11. Toxicological Information

Acute Toxicity: Low acute oral toxicity, LD50 (rat, oral) > 1000 mg/kg
Skin Irritation: Possible mild irritant
Eye Irritation: May cause irritation
Respiratory Sensitization: May cause respiratory irritation or asthma-like symptoms in sensitive individuals
Carcinogenicity: No evidence for carcinogenic effects
Mutagenicity: No mutagenic potential found in standard assays
Reproductive Toxicity: No data available for reproductive/developmental effects in humans
Target Organs: Respiratory tract, skin, eyes (with excessive exposure)

12. Ecological Information

Eco-toxicity: No significant aquatic or terrestrial toxicity established for typical concentrations
Persistence and Degradability: Not readily biodegradable, no rapid degradation
Bioaccumulation Potential: No data, expected to have low bioaccumulation
Mobility in Soil: No data, but highly soluble in water
Other Adverse Effects: Avoid large discharges into environment, follow proper disposal

13. Disposal Considerations

Recommended Disposal Methods: Treat as pharmaceutical waste, incinerate or landfill as permitted by local regulations
Disposal of Contaminated Packaging: Dispose as unused product unless rinsed or decontaminated
Precautions: Avoid release to the environment, follow all federal, state, and local laws

14. Transport Information

UN Number: Not classified as dangerous for transport
Transport Hazard Class: Not regulated
Packing Group: None
Special Precautions: Use suitable packaging to prevent contamination or accidental release during transportation
Proper Shipping Name: Non-hazardous material

15. Regulatory Information

Safety, Health and Environmental Regulations: Not subject to specific labelling or hazard classification under GHS or US OSHA regulations
REACH Registration: Not listed for specific restrictions
Inventory Status: Registered under appropriate chemical inventories (US TSCA: not listed; EU EINECS: listed)
Other Regulations: Check relevant country-specific regulations and local requirements for handling pharmaceuticals