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Product Name: Esomeprazole Sodium
Synonyms: S-Omeprazole Sodium Salt
Chemical Family: Benzimidazole derivative
CAS Number: 161796-78-7
Use: Active pharmaceutical ingredient for acid-related disorders
Manufacturer: Company details and emergency contact numbers available on product packaging and official safety documents
GHS Classification: Not classified as hazardous according to current standards
Primary Route of Exposure: Inhalation, skin, eyes
Hazard Pictograms: Not applicable for bulk material but dust may irritate mucous membranes
Signal Word: None required under GHS
Health Hazards: Dust may cause respiratory tract and skin irritation, eye irritation possible upon direct contact
Environmental Hazards: No acute hazard but large quantities may impact aquatic environments
Chemical Name: Esomeprazole Sodium
Molecular Formula: C17H18N3NaO3S
Molecular Weight: 367.40 g/mol
Concentration: 100% when pure
Impurities: Manufacturing process may leave trace solvents or related substances within regulatory limits
Inhalation: Move affected person to fresh air immediately, seek medical attention if symptoms persist
Skin Contact: Wash affected area thoroughly with plenty of water and soap, remove contaminated clothing
Eye Contact: Rinse eyes cautiously with water for several minutes, lift upper and lower eyelids for thorough flush, seek medical help if irritation develops
Ingestion: Rinse mouth with water, consult medical personnel soon as feasible, do not induce vomiting without guidance
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Extinguishing Media: Direct water jet could spread powder
Specific Hazards: Combustion may produce toxic fumes, oxides of carbon and nitrogen, and sulfur compounds
Protective Equipment: Firefighters should wear self-contained breathing apparatus and chemical protective clothing
Special Procedures: Evacuate area, contain run-off with barriers
Personal Precautions: Wear protective clothing, gloves, goggles, avoid dust inhalation
Environmental Precautions: Avoid release to drains, soil, or waterways, absorb spills using inert non-combustible material
Methods for Cleanup: Sweep up using dust-tight equipment, collect residue in suitable closed containers for disposal, ventilate area
Handling: Handle with care, avoid creating dust, work in well-ventilated areas, use personal protective equipment when exposure limits may be exceeded
Storage: Store in original tightly closed containers, keep in cool, dry, well-ventilated area, protect from moisture and direct sunlight, segregate away from incompatible substances like oxidizers and acids
Special Precautions: Training workers on risks and safe handling reduces incidents
Exposure Limits: No established occupational exposure limit for active ingredient, handle as pharmaceutical with caution
Engineering Controls: Labs should use local exhaust ventilation or pharmaceutical isolators
Personal Protection: Nitrile gloves, protective eyewear, lab coats, particulate respirator for dust
Environmental Controls: Filters or scrubbers on process exhausts minimize release
Appearance: White to off-white powder
Odor: Odorless
pH: 9.5–11.5 (1% solution in water)
Boiling Point: Not applicable (decomposes prior to boiling)
Melting Point: Decomposes before melting above 155°C
Solubility: Freely soluble in water, practically insoluble in most organic solvents
Vapor Pressure: Not measured, negligible
Partition Coefficient (log P): 0.7–1.1
Chemical Stability: Stable under recommended handling and storage conditions
Reactivity: No significant reactivity with normal substances, avoid contact with acids and oxidizing agents
Decomposition: High temperatures or acids may generate toxic gases including nitrogen oxides, sulfur oxides
Acute Toxicity: Low acute oral toxicity based on animal studies, category 5 under GHS
Skin Corrosion/Irritation: Mild irritant in sensitive individuals
Serious Eye Damage/Irritation: May cause redness or discomfort
Respiratory or Skin Sensitization: No reports of sensitization under usual handling
Long-term Effects: Studies in animals show typical dose-dependent effects at high exposure levels
Carcinogenicity/Mutagenicity: Studies indicate no carcinogenic or mutagenic risk at therapeutic doses
Eco-Toxicity: At standard concentrations low risk, but large quantities may harm aquatic species
Mobility: Readily soluble in water, may migrate in moist environments
Persistence and Degradability: Likely to persist in groundwater for some time, slow biodegradation
Bioaccumulation Potential: Low, limited potential based on partition coefficient
Other Adverse Effects: Limited data, avoid large uncontrolled releases
Disposal Methods: Follow local, regional, and national regulations, use licensed chemical waste contractor
Unused Product: Incineration preferred when possible, do not release to sewer systems
Contaminated Packaging: Triple rinse, then dispose of as hazardous waste
UN Number: Not regulated as hazardous for transport
Transport Hazard Class: Not classified
Packing Group: None required
Special Transport Precautions: Ship in tightly closed, appropriately labeled containers, protect from physical damage and moisture
Classification: Not categorized as dangerous under UN GHS or EU CLP regulations
SARA/OSHA Status (US): Not listed among hazardous substances
WHMIS (Canada): Not controlled
REACH Status (Europe): Complies with pre-registration or exemption for pharmaceuticals
Other Regulations: Evaluate compliance according to specific region and sector, review product documentation folders for full details
