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Product Name: Sulbactam Sodium - Non-Sterile
Chemical Family: Beta-lactamase inhibitor, Sulfonic acids (derivatives)
Chemical Formula: C8H10NNaO5S
CAS Number: 69388-84-7
Use: Pharmaceutical intermediate for antibiotic formulations
Synonyms: Sulbactam sodium salt
Contact Information: Emergency response phone provided by manufacturer or distributor; address and phone for manufacturer/supplier
Classification: Not classed as hazardous under standard GHS criteria; dust can irritate airways, eyes, and skin
Primary Hazards: Respiratory tract, skin and eye irritation, possible allergic reactions from prolonged exposure or repeat contact
Signal Word: Warning
Pictograms: Exclamation mark (irritant)
Hazard Statements: May cause mild respiratory or dermal irritation; not considered acutely toxic
Precautionary Statements: Avoid dust generation and inhalation; use appropriate PPE for handling active pharmaceutical ingredients
Main Ingredient: Sulbactam Sodium
Concentration: >96%
Other Components: Non-active pharmaceutical-grade excipients possibly present in trace quantities due to manufacturing process
Impurities: None at hazardous levels as per manufacturing specifications
Inhalation: Move to fresh air; seek medical attention if symptoms persist; provide oxygen if breathing difficulty arises
Skin Contact: Wash skin thoroughly with soap and water; remove contaminated clothing; get medical advice for persistent redness, swelling, or rash
Eye Contact: Rinse with plenty of water for at least 15 minutes lifting eyelids; seek medical help if irritation does not clear
Ingestion: Rinse mouth with water; avoid inducing vomiting; obtain medical attention if large quantities or symptoms develop
Most Important Symptom: Allergic reactions in sensitized individuals including skin rash, respiratory symptoms
Suitable Extinguishing Media: Use water spray, carbon dioxide, dry chemical powder, or foam for small fires involving powder or dust
Hazards from Combustion: Emits toxic fumes under intense heat—sulfur oxides, nitrogen oxides, sodium oxides
Special Firefighting Equipment and Precautions: Wear self-contained breathing apparatus, full protective gear to minimize exposure to fumes
Specific Fire Risks: Fine dust can create explosion hazard in air; take precautions to avoid dust buildup
Personal Precautions: Wear suitable respiratory protection and gloves; avoid inhalation and skin contact
Environmental Precautions: Keep out of drains and groundwater to control pharmaceutical contamination of the environment
Cleanup Methods: Vacuum or wet-sweep using equipment with high-efficiency particulate filter; prevent dust generation; dispose of in closed, labeled containers
Spill Response: Isolate area, ventilate; wash contaminated area with water after cleanup
Handling: Minimize dust generation; work under local exhaust ventilation; avoid contact with skin, eyes, and clothing; industrial hygiene controls essential
Storage Conditions: Store in a tightly closed original container, in a dry, cool, well-ventilated place; keep away from incompatible substances like strong acids or bases
Storage Incompatibilities: Avoid oxidizers, moisture, and direct sunlight
Recommended Packaging: Use sealed pharmaceutical-grade containers labeled for traceability
Occupational Exposure Limits: No established OSHA or ACGIH limits, pharmaceutical workplace guidance suggests lowest feasible exposure
Engineering Controls: Handle in a ventilated enclosure; use local exhaust
Personal Protective Equipment: Gloves (nitrile or latex), lab coat, eye protection (chemical splash goggles), respirator for handling powder outside of containment
Hygiene Measures: No eating, drinking, or smoking in work area; wash thoroughly after use
Environmental Controls: Prevent release into surface water and soil
Appearance: White to off-white crystalline or amorphous powder
Odor: Odorless
Odor Threshold: Not applicable
pH (1% Solution): About 6.0–8.5
Melting Point: Decomposes above 220°C
Solubility: Freely soluble in water; slightly soluble in some organic solvents
Vapor Pressure: Not volatile
Density: Approx. 1.71 g/cm³
Flash Point: Not applicable
Explosion Properties: Fine dust may form explosive mixtures with air
Partition Coefficient (log Pow): Data not available
Viscosity: Not applicable
Decomposition Temperature: >220°C
Chemical Stability: Stable in dry, closed containers at room temperature below 25°C; moisture sensitive
Reactivity: Incompatible with strong oxidizing agents and acids
Hazardous Decomposition Products: Combustion forms sulfur oxides, nitrogen oxides, sodium oxides
Possibility of Hazardous Reactions: Not expected under recommended storage and handling conditions
Conditions to Avoid: Heat, humidity, light, and open flames
Polymerization: Does not occur
Acute Toxicity: Oral LD50 (rat) reported >2,000 mg/kg, may cause gastrointestinal upset
Inhalation: Dust may irritate airways, cause coughing
Skin Contact: Can cause mild irritation or allergic reactions in sensitive individuals
Eye Contact: May irritate eyes with redness or stinging
Chronic Exposure: Reports of allergic reactions in pharmaceutical workers; includes dermatitis, asthma with repeated contact
Mutagenicity, Carcinogenicity: Not classified by IARC; no strong evidence for mutagenic or carcinogenic effects in studies
Special Health Risks: Atopic persons may react at lower exposures; strict industrial hygiene controls help prevent occupational disease
Environmental Impact: No large-scale environmental hazard data; high concentrations harmful for aquatic life, especially microorganisms
Mobility: Soluble in water; may migrate in soil
Persistence/Degradability: Expected to degrade slowly in aquatic environments
Bioaccumulative Potential: Potential considered low due to water solubility
Aquatic Toxicity: Data on direct aquatic toxicity limited; minimize release to sewers or waterways to avoid pharmaceutical pollution
Waste Disposal Methods: Dispose of in sealed containers through licensed chemical waste contractors according to local environmental regulations
Special Precautions: Do not allow material to reach sewage system or water sources
Unused Product: Incinerate in approved facility or send to chemical landfill
Contaminated Packaging: Triple rinse and send to approved recycling or disposal facility; label as pharmaceutical waste
UN Number: Not regulated as a dangerous good for transport under most international standards
Proper Shipping Name: Not restricted
Transport Hazard Class: No classification required
Packing Group: Not assigned
Environmental Risks: Not considered a marine pollutant
Special Precautions for User: Keep containers closed and upright; protect from moisture during transit
TSCA Status: Not listed on TSCA
OSHA: Not specifically regulated; standard chemical hygiene protocols in laboratories or cleanrooms apply
EU Regulations: Classified as non-hazardous under Regulation (EC) No 1272/2008
WHMIS (Canada): Not controlled
Other Country-Specific Regulation: Pharmaceutical substance, subject to restrictions for manufacture, transport, and environmental release according to local laws
