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Material Safety Data Sheet for Indacaterol Maleate

Identification

Product Name: Indacaterol Maleate
Chemical Formula: C24H28N2O3•C4H4O4
Synonyms: Indacaterol Maleate salt
CAS Number: 753498-25-8
Manufacturer Information: Pharmaceutical and chemical companies handling bronchodilators.
Recommended Use: For research, laboratory, and pharmaceutical manufacturing.
Restrictions on Use: Only for qualified professionals—avoid general consumer use due to specialized handling needs.

Hazard Identification

Classification: Classified as hazardous based on international standards for respiratory sensitisers and irritants.
Label Elements: Contains warning symbols for harmful by inhalation, skin, or eye exposure.
Hazard Statements: Can cause breathing difficulties, skin irritation, and eye redness.
Precautionary Statements: Minimize dust creation, wear suitable protective gear, store securely, and avoid direct contact.

Composition / Information on Ingredients

Substance: Indacaterol Maleate
Chemical Identity: Indacaterol (active component), Maleic Acid (counter-ion)
Concentration: >98% purity for research grade material
Impurities: Trace solvents, residual water, possible related substances from synthesis under strict manufacturing controls.

First Aid Measures

Inhalation: Remove to fresh air and monitor breathing, seek medical advice if symptoms such as coughing or shortness of breath appear.
Skin Contact: Immediately wash with plenty of water and soap, remove contaminated clothing, medical attention if irritation or rash develops.
Eye Contact: Rinse eyes slowly and gently with water for several minutes, lift upper and lower eyelids occasionally, obtain medical attention.
Ingestion: Rinse mouth with water, do not induce vomiting, seek immediate medical care, especially if feeling unwell or experiencing allergic reaction.

Fire-Fighting Measures

Suitable Extinguishing Media: Use foam, dry chemical powder, or carbon dioxide.
Unsuitable Media: Avoid high pressure water jets which might spread the chemical.
Specific Hazards: Emits toxic fumes of nitrogen oxides and carbon oxides when burning.
Special Protective Equipment for Firefighters: Full protective clothing and approved self-contained breathing apparatus.

Accidental Release Measures

Personal Precautions: Use gloves, goggles, and dust masks; avoid inhaling dust or vapors.
Environmental Precautions: Prevent spill from entering drains or waterways; inform local authorities if significant contamination occurs.
Methods for Clean-Up: Gently scoop up spilled powder, place in a closable container for disposal, ventilate the area, decontaminate surfaces with suitable detergent solution.

Handling and Storage

Precautions for Safe Handling: Use indoors with proper exhaust ventilation, keep container tightly sealed, avoid contact with eyes, skin, or clothing.
Conditions for Safe Storage: Store in a cool, dry, well-ventilated space, away from direct sunlight and incompatible substances.
Storage Temperature: Preferably below 25°C, tightly closed, in original packaging or equivalent glass or HDPE container.

Exposure Controls and Personal Protection

Engineering Controls: Chemical fume hood, HEPA-filtered exhaust for powder handling, splash-proof eyewash stations in workplace.
Personal Protective Equipment (PPE): Laboratory coat, nitrile gloves, safety goggles, and where dust exceeds safe limits, use certified respirator.
Workplace Exposure Controls: Routine air monitoring, strict surface decontamination, established emergency protocols for spills or exposure.

Physical and Chemical Properties

Appearance: White or almost white, crystalline powder.
Odor: Odorless.
pH (1% solution): Slightly acidic to neutral.
Melting Point: Approximately 197–204°C.
Solubility: Soluble in DMSO, slightly soluble in water and methanol.
Vapor Pressure: Low.
Particle Size: Fine powder; risk of dust generation during handling.

Stability and Reactivity

Chemical Stability: Stable under standard laboratory and storage conditions.
Reactivity: Avoid contact with strong oxidizers or acids; risk of hazardous decomposition if heated strongly.
Decomposition Products: Carbon oxides, nitrogen oxides, and possibly other toxic vapors when burning or subject to hydrolysis.

Toxicological Information

Acute Toxicity: Limited animal toxicity data show risks via oral, dermal, and inhalation exposure; not meant for household or unsupervised handling.
Chronic Effects: Experimental inhalation can sensitize airways; skin exposure might induce sensitization; not enough long-term studies in humans.
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion—all routes associated with adverse effects during unprotected exposure.
Symptoms: Throat and respiratory discomfort, skin rash, eye irritation, headache, possible allergic reaction.

Ecological Information

Ecotoxicity: Data limited, but risk to aquatic organisms likely if released in significant amounts.
Persistence and Degradability: Only partial degradation expected under normal environmental conditions.
Bioaccumulation Potential: Not predicted to bioaccumulate significantly based on molecular structure, but long-term data lacking.
Mobility in Soil: Some mobility possible for small quantities when spilled to ground; best practice is to contain all residues.

Disposal Considerations

Waste Management: Collect and segregate chemical waste for professional disposal.
Disposal Methods: Incinerate using a licensed hazardous waste facility; do not release to sewer, surface water, or uncontrolled locations.
Contaminated Packaging: Triple rinse with water and detergent, then treat as chemical waste or dispose of according to regulations.

Transport Information

UN Number: Not assigned internationally for small research-scale shipments but always verify with local regulations.
Transport Hazard Class: Not classified as a dangerous good for air, sea, or road, unless carried in bulk amounts.
Packing Group: No mandatory group at lab scale; use leakproof, shatterproof containers.
Proper Shipping Name: Indacaterol Maleate (for research purposes).
Transport Precautions: Avoid temperature extremes during transport, keep containers upright and secure.

Regulatory Information

International Regulations: Listed or regulated under major chemical inventory schemes such as REACH, TSCA, and others for pharmaceutical intermediates.
Labeling Compliance: GHS labeling with hazard pictograms and precautionary measures strictly required in professional settings.
Other Local or National Requirements: Notification to workplace health and safety authorities recommended for larger-scale handling; include in workplace chemical inventory records.
Worker Training: Personnel must complete hazard communication training for safe handling, emergency response, and personal protection procedures.