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Product Name: Montelukast Sodium
Chemical Name: Sodium 1-[[[(1R)-1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropyl]acetate
Synonyms: Singulair, sodium 1-[({[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio}methyl)cyclopropyl]acetate
CAS Number: 151767-02-1
Recommended Uses: Active pharmaceutical ingredient for management of asthma and allergic rhinitis
Manufacturer Information: [Your company’s details, address, emergency contact number]
GHS Classification: Not classified as a hazardous substance under GHS
Physical Hazards: Dry powder poses minimal fire risk but can create dust clouds
Health Hazards: May cause skin or eye irritation. Inhalation of large amounts could irritate respiratory tract. Individuals sensitive to sulfides could experience allergic reactions.
Environmental Hazards: No long-term ecological effects known; avoid disposal in large quantities into waterways.
Label Elements: Not required to display specific pictograms for this compound according to most regulations.
Chemical Name: Montelukast Sodium
Purity: ≥ 98%
Molecular Formula: C35H35ClNNaO3S
Molecular Weight: 608.2 g/mol
Impurities: Trace process-related organic impurities at less than 0.2% each
Stabilizing Additives: None intentionally added
Eye Contact: Rinse thoroughly with plenty of water for at least 15 minutes. Remove contact lenses if present and easy to do. Seek medical attention for persistent irritation.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing as soon as possible. If irritation occurs or persists, consult medical personnel.
Inhalation: Move to fresh air. Support breathing as needed. For persistent cough, breathing difficulty, or other symptoms, seek medical attention.
Ingestion: Rinse mouth, drink water if conscious. Do not induce vomiting unless instructed by medical personnel. Seek medical attention if large quantities are consumed or if symptoms develop.
Symptoms and Effects: Dust can cause irritation of mucous membranes, skin, and eyes. Over-exposure may cause gastrointestinal disturbances.
Suitable Extinguishing Media: Water spray, carbon dioxide, alcohol-resistant foam, or dry chemical powder.
Hazards from Combustion: Burning produces carbon oxides, sulfur oxides, nitrogen oxides, hydrogen chloride, and sodium oxide fumes.
Protective Equipment for Firefighters: Use self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
Special Fire-Fighting Procedures: Prevent runoff from firefighting from entering water sources or public sewers.
Personal Precautions: Use personal protective gear including gloves, goggles, and dust mask to avoid inhalation or skin contact. Ventilate area and approach leaking powder from upwind.
Environmental Precautions: Prevent product dust from entering drains or waterways. Notify relevant authorities if large-scale spillage contaminates the environment.
Methods for Cleanup: Collect spilled powder with an industrial vacuum or by moistening with water to reduce dust generation. Collect in appropriate containers for disposal. Clean area thoroughly with water.
Handling: Avoid inhaling dust and contact with skin or eyes. Work in well-ventilated environments. Use local exhaust ventilation.
Storage: Keep in tightly closed containers, stored in a cool, dry place away from incompatible substances like oxidizers. Protect from light and moisture. Maintain at 2-8°C for long-term stability.
Hygiene Practices: Wash hands and face after handling powder. Do not eat, drink, or smoke in areas where this product is handled.
Occupational Exposure Limits: No established exposure limits for montelukast sodium
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to minimize airborne exposure.
Personal Protective Equipment: Wear safety glasses with side shields, chemical-resistant gloves, laboratory coat, and dust mask or respirator if dust levels are above the recommended threshold.
Environmental Measures: Prevent further leakage or spillage if safe to do so. Avoid discharge into the environment.
Appearance: White to off-white powder or crystalline solid
Odor: Odorless
pH (1% aqueous): 7–9
Melting Point: 137°C
Boiling Point: Not applicable (decomposes)
Solubility: Freely soluble in water, methanol, ethanol; poorly soluble in dichloromethane
Partition Coefficient (log P): 3.2
Vapor Pressure: Negligible
Relative Density: About 1.2–1.3 g/cm³
Flammability: Not classified as flammable, but may burn at high temperatures
Chemical Stability: Stable under recommended storage conditions. Sensitive to prolonged exposure to light and moisture.
Hazardous Reactions: No dangerous reactions known during normal processing and storage.
Incompatible Materials: Strong oxidizing agents, strong acids
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides, sodium oxide, hydrogen chloride
Acute Toxicity: Oral LD50 in rodents above 2000 mg/kg. Inhalation and dermal exposure show low acute toxicity.
Skin Corrosion/Irritation: Mild skin irritation possible after contact.
Eye Damage/Irritation: Can cause temporary discomfort or redness.
Respiratory Sensitization: Dust inhalation can cause coughing or sneezing; hypersensitization possible with repeated or prolonged exposure.
Chronic Toxicity: No long-term toxicity reported at therapeutic doses in humans. Animal testing did not show carcinogenic effects.
Reproductive Effects: No evidence of reproductive toxicity in animal studies; recommended precautions for women who are pregnant or breastfeeding.
Ecotoxicity: No evidence of acute or chronic toxicity to aquatic organisms at typical environmental concentrations.
Persistence and Degradability: Not rapidly biodegradable; stable compound in the environment.
Bioaccumulation: Low potential for bioaccumulation
Mobility in Soil: Moderately mobile in soil due to solubility characteristics.
Other Adverse Effects: Avoid large-scale release into watercourses to reduce unknown risks to ecosystems.
Waste Treatment: Dispose of in accordance with local, regional, and national regulations. Incineration preferred for large quantities.
Container Disposal: Clean and dispose of container as hazardous chemical waste.
Special Precautions: Prevent release to the environment during disposal; do not discharge into sewage systems or natural waters.
UN Number: Not regulated for transport
UN Proper Shipping Name: Not classified as hazardous for transport purposes
Transport Hazard Class(es): None
Packing Group: Not assigned
Environmental Hazards: Non-hazardous for marine and air transport
Special Precautions: Protect containers from physical damage during transit. Avoid moisture and exposure to direct sunlight.
Regulatory Compliance: Montelukast sodium complies with relevant US FDA, EMA, ICH, and WHO recommendations for pharmaceutical excipients.
OSHA Status: Not considered hazardous under US OSHA criteria.
SARA Title III: Not listed
TSCA Certification: Not regulated
REACH Status: Exempt as an active pharmaceutical substance in finished drug product.
Other Local Laws: Ensure reporting and management aligns with local workplace safety and handling requirements.
