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MSDS for Cefotaxime Sodium

Identification

Product Name: Cefotaxime Sodium
Chemical Family: Cephalosporin antibiotic
CAS Number: 64485-93-4
Molecular Formula: C16H16N5NaO7S2
Synonyms: Claforan, Sodium Cefotaxime
Manufacturer: Pharmaceutical company specializing in antibiotics
Recommended Uses: Treatment of bacterial infections
Emergency Contact: Local poison control center, medical professional

Hazard Identification

GHS Classification: Acute toxicity (oral, dermal), Eye irritation, Respiratory irritation, Skin sensitizer
Hazard Symbols: Exclamation mark, Health hazard
Signal Word: Warning
Hazard Statements: May cause allergic skin reaction; May cause respiratory irritation; Harmful if swallowed; Serious eye irritation reported in handling; Potential for anaphylactic shock in sensitive individuals
Precautionary Statements: Avoid breathing dust; Wear gloves and eye protection; Wash hands after handling; Remove contaminated clothing; Seek medical advice if exposed or concerned

Composition / Information on Ingredients

Cefotaxime Sodium: 93%-98%
Excipients: Trace amounts of sodium carbonate or sodium bicarbonate for pH adjustment
Impurities: Less than 1%, specified by the manufacturer
Inactive Components: None intended for clinical preparations

First Aid Measures

Inhalation: Move affected person to fresh air; Seek medical attention for breathing difficulty or persistent cough
Skin Contact: Remove contaminated clothes; Wash affected area with soap and water for at least 15 minutes; If irritation or allergic reaction develops, consult a physician
Eye Contact: Rinse eyes cautiously with water for several minutes; Remove contact lenses if present and continue rinsing; Seek immediate medical advice for persistent symptoms
Ingestion: Rinse mouth with water; Do not induce vomiting; Seek immediate medical attention; Provide information on substance ingested
Most Important Symptoms: Allergic reactions, difficulty breathing, skin rash, gastrointestinal symptoms

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Extinguishing Media: None identified for laboratory or clinical amounts
Hazardous Combustion Products: Nitrogen oxides, sulfur oxides, carbon oxides, sodium oxides
Special Protective Equipment: Full protective clothing and self-contained breathing apparatus; Ensure adequate ventilation
Firefighting Instructions: Cool containers with water spray; Avoid inhalation of combustion products; Remove personnel from the vicinity of the fire if safe to do so

Accidental Release Measures

Personal Precautions: Avoid dust formation; Use appropriate personal protection such as gloves, mask, goggles
Environmental Precautions: Prevent runoff into sewers, soil, or water systems
Cleanup Methods: Sweep or vacuum material into suitable container; Avoid generating dust; Wash spill area with water and detergent after cleanup
Disposal: Collect in properly labeled containers for disposal according to local regulations
Decontamination: Use soap solution or detergent solution for surfaces; Ventilate area properly

Handling and Storage

Handling: Handle in a well-ventilated area; Use gloves and laboratory coat to reduce risk of skin contact; Avoid inhaling dust or contact with eyes, skin, clothing
Hygiene Practices: Wash hands thoroughly after use; Do not eat, drink, or smoke in the work area
Storage: Store in tightly closed containers in a cool, dry place; Keep away from incompatible materials and light; Temperature controlled conditions between 2°C and 8°C
Incompatibilities: Strong acids, strong bases, oxidizing agents
Storage Life: Follow manufacturer’s recommendation, do not use after expiration date

Exposure Controls and Personal Protection

Occupational Exposure Limits: Not established for Cefotaxime Sodium; Handle as a pharmaceutical agent
Engineering Controls: Use local exhaust ventilation in areas where dust may be generated; Implement closed systems for reconstitution
Personal Protection: Chemical-resistant gloves (nitrile or latex), safety goggles, protective laboratory coat
Respiratory Protection: NIOSH-approved dust mask if exposure may exceed occupational standards
Environmental Controls: Prevent uncontrolled release; Use containment practices for pharmaceuticals; Monitor workplace environment for dust levels

Physical and Chemical Properties

Physical State: Powder or crystalline solid
Color: White to slightly yellow
Odor: Odorless or faint medicinal smell
Molecular Weight: 477.5 g/mol
Solubility: Freely soluble in water, slightly soluble in ethanol, insoluble in ether
pH (solution): 6.0-8.0 (for a 4% solution)
Melting Point: Not determined due to decomposition
Boiling Point: Not applicable
Flash Point: Not flammable under normal conditions
Partition Coefficient: Data not available
Vapor Pressure: Negligible
Other Properties: Hygroscopic, stable under recommended storage conditions

Stability and Reactivity

Chemical Stability: Stable under normal temperatures and pressures when protected from moisture and light
Hazardous Reactions: May react with strong oxidizing or reducing agents
Conditions to Avoid: Exposure to moisture, high temperatures, acids, bases, prolonged exposure to light
Incompatible Materials: Acids, alkalis, oxidizers
Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides, sodium compounds

Toxicological Information

Routes of Exposure: Inhalation, ingestion, skin contact, eye contact
Acute Toxicity: LD50 (oral, rat) > 5,000 mg/kg (low acute toxicity); Allergic reactions including rash and respiratory issues
Chronic Toxicity: Repeated exposure may cause sensitization and hypersensitivity reactions; No evidence of carcinogenicity by available data
Symptoms: Nausea, vomiting, allergic skin reactions, difficulty breathing, anaphylaxis in susceptible individuals
Target Organs: Immune system, skin, respiratory tract
Other Effects: Use in pregnancy and lactation only if clearly needed; Counseling recommended before handling for people with beta-lactam allergy
Mutagenicity: Negative in standard microbial assays, not classified as mutagenic

Ecological Information

Environmental Fate: Not readily biodegradable; Persistence in water and soil can occur
Ecotoxicity: Harmful to aquatic life at high concentrations; May disrupt microbial populations in sewage treatment plants
Bioaccumulation: Low potential based on water solubility and structure
Mobility: High in water, unlikely to absorb strongly to soils or sediments
Aquatic Toxicity: Some toxicity towards algae, daphnia, and fish at elevated concentrations
Precautions: Avoid uncontrolled discharges to environment; Treat as a pharmaceutical contaminant

Disposal Considerations

Waste Treatment Methods: Dispose of material in compliance with applicable local, regional, and national regulations; Use licensed pharmaceutical waste contractor for large quantities
Unused Product: Incineration preferred for bulk material; Avoid release to sewers and natural water sources
Contaminated Packaging: Rinse and dispose of according to legal requirements; Label as pharmaceutical waste
Additional Notes: Consult regulatory authorities for proper disposal procedures

Transport Information

UN Number: Not regulated as a hazardous material under most transport regulations
UN Shipping Name: Not applicable
Transport Hazard Class: Not assigned
Packing Group: Not assigned
Transport Precautions: Protect from moisture and temperature extremes; Keep container tightly closed during transport
Labeling Requirements: Label as pharmaceutical; Medical use only indication recommended on package
Special Precautions: Avoid crushing and dust release during transport; Handle in original packaging if possible
Marine Pollutant: Not classified, but avoid large discharges into waterways

Regulatory Information

International Standards: Not specifically listed as a controlled substance; Regulated as a prescription drug in all major markets
OSHA Status: Not listed as hazardous, but use good laboratory practices
TSCA Status: Exempt for pharmaceutical research, not listed
REACH Registration: No full registration required for clinical use; Handle according to general chemical safety obligations
Other Regulations: Subject to national pharmaceutical control laws and disposal guidelines; Comply with workplace safety standards for handling bioactive compounds
Labeling: Product labels to indicate medical use, batch and lot number, expiry date, hazard notes, and storage requirements