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Material Safety Data Sheet (MSDS) for Omeprazole Sodium

Identification

Product Name: Omeprazole Sodium
Chemical Name: 5-Methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]-1H-benzimidazole sodium salt
CAS Number: 95510-70-6
Molecular Formula: C17H18N3NaO3S
Recommended Use: Treatment of gastroesophageal reflux disease, peptic ulcer, and associated conditions
Manufacturer Information: Contact information for chemical manufacturer, supplier, or importer available on request
Emergency Phone Number: Refer to local regulatory guidelines and materials

Hazard Identification

Classification: Not classified as hazardous under GHS regulations; for laboratory-scale use may cause allergic skin reaction and eye irritation
Label Elements: May include warning symbol for irritants; hazard statements: may cause skin or eye irritation, possible respiratory irritation with dust
Potential Health Effects: May aggravate asthma or respiratory symptoms on repeated inhalation; long-term exposure not fully studied in non-therapeutic populations
Signal Word: Warning
Precautionary Statements: Avoid breathing dust, avoid contact with eyes or skin, use personal protective equipment

Composition / Information on Ingredients

Chemical Name: Omeprazole Sodium
Synonyms: Omeprazole sodium salt, Prilosec sodium salt
CAS Number: 95510-70-6
Concentration: Pure substance (may be diluted in pharmaceutical preparations)
Impurities: Typical for pharmaceutical substances but not significant for workplace risk under normal circumstances
Additives: None deliberately included in technical or pure samples

First Aid Measures

Inhalation: Move person to fresh air, seek medical attention for ongoing symptoms
Skin Contact: Wash with soap and water, remove contaminated clothing, if irritation develops see a medical professional
Eye Contact: Rinse carefully with plenty of water for several minutes, remove contact lenses if present, consult physician if discomfort persists
Ingestion: Rinse mouth, drink water; medical attention recommended especially for large quantities or symptoms
Most Important Symptoms/Effects: Allergic reactions, mild skin or respiratory irritation possible
Note to Physicians: Provide symptomatic treatment as needed

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam for small fires
Hazards from Combustion: Sodium oxides, nitrogen oxides, sulfur compounds, carbon monoxide and dioxide may form in fire conditions
Protective Equipment: Firefighters should use self-contained breathing apparatus and protective clothing
Specific Hazards: Dust dispersal in air may be explosive, avoid dust clouds in confined space

Accidental Release Measures

Personal Precautions: Use appropriate personal protection such as gloves, goggles, dust mask
Environmental Precautions: Prevent further leakage or spillage if safe to do so, do not let product enter waterways or soil
Methods for Clean Up: Use damp wiping or HEPA vacuum for collecting powder, avoid raising dust, collect in sealed containers for proper disposal
Reference to Other Sections: Follow local, industry, and national safety standards for cleaning chemical spills

Handling and Storage

Handling: Avoid generating dust, use only in well-ventilated areas, practice good industrial hygiene
Hygiene Measures: Wash hands thoroughly after handling, prohibit eating, drinking, or smoking in work area
Storage: Store in a tightly closed container, away from light, moisture, and incompatible materials, maintain moderate temperature and dry conditions
Incompatibilities: Avoid storage with oxidizing agents, acids

Exposure Controls and Personal Protection

Exposure Limits: No occupational exposure limits established for Omeprazole Sodium specifically
Engineering Controls: Use local exhaust ventilation or fume hood to control dust
Personal Protective Equipment: Chemical-resistant gloves, safety glasses with side shields, laboratory coat, approved dust respirator under dusty conditions
Other Protective Measures: Emergency eyewash and shower accessible in work area, monitor airborne dust if significant handling occurs

Physical and Chemical Properties

Appearance: White or off-white, crystalline powder
Odor: Odorless or faint pharmaceutical scent
pH: Slightly basic in aqueous solution
Melting Point/Freezing Point: Decomposes before melting, decomposition temperature typically around 150–160°C
Boiling Point: Not applicable, decomposes
Solubility: Freely soluble in water, soluble in ethanol
Vapor Pressure: Negligible
Relative Density: Around 1.2 g/cm³
Partition Coefficient: logP (octanol/water) estimated around 2.2 (for Omeprazole base)
Other Data: Not volatile under normal conditions, stable to moderate light exposure

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Hazardous Reactions: May react with strong acids, oxidizers, some metals
Conditions to Avoid: Avoid heat, humidity, and exposure to light
Incompatible Materials: Strong oxidizing agents, strong acids
Hazardous Decomposition Products: Sodium oxide, sulfur oxides, nitrogen oxides, carbon oxides

Toxicological Information

Acute Toxicity: Oral LD50 for rats estimated over 2000 mg/kg (low toxicity)
Skin Corrosion/Irritation: Prolonged contact may cause mild irritation
Serious Eye Damage/Irritation: May cause transient irritation
Respiratory or Skin Sensitization: Possible allergenic response in sensitive individuals
Carcinogenicity: Not classed as carcinogenic for humans under IARC, OSHA, NTP
Reproductive Toxicity: No significant evidence at therapeutic doses; high doses not recommended for pregnant animals
Signs/Symptoms of Exposure: Skin or eye irritation, respiratory discomfort, allergic reactions may develop for some workers

Ecological Information

Ecotoxicity: No acute aquatic toxicity data for sodium salt but omeprazole base shows low hazard to aquatic life at environmental concentrations
Persistence and Degradability: Moderate persistence in surface waters, degrades through hydrolysis and photolysis
Bioaccumulative Potential: Omeprazole sodium has low potential for bioaccumulation based on its physicochemical properties
Mobility in Soil: Readily mobile in surface and ground waters, may leach from waste sites
Other Adverse Effects: No significant threat anticipated for wildlife at low concentrations, but disposal to environment not advised

Disposal Considerations

Waste Treatment: Dispose via licensed chemical waste contractor in accordance with local and national regulations
Special Precautions for User: Avoid discharge to sewers or surface water, do not dispose as general waste
Packaging: Contaminated packaging requires incineration or disposal as pharmaceutical waste
Physical/Chemical Properties Affecting Disposal: Stable as a solid, should not enter the environment in significant amounts

Transport Information

UN Number: Not regulated under UN, ICAO, IMDG, USDOT rules for road, air, or marine shipment
Proper Shipping Name: Not classified as hazardous for transport
Transport Hazard Class: Not applicable
Packing Group: Not required
Marine Pollutant: Not designated
Special Precautions for Transport: Secure tightly sealed packages, keep away from incompatible materials

Regulatory Information

Workplace Safety: Substance not specifically listed under OSHA, but general chemical hygiene rules apply
TSCA Inventory: Not required for pharmaceutical products
REACH (Europe): Not directly listed, though final products must comply with relevant medicinal and chemical regulation
Labeling Requirements: Label in accordance with GHS and local legislation for workplace chemicals
Other Regulations: National, state, and local regulations for pharmaceutical agents may apply depending on jurisdiction