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Material Safety Data Sheet (MSDS) for Ceftriaxone Sodium - Sterile

Identification

Product Name: Ceftriaxone Sodium - Sterile
Chemical Formula: C18H16N8Na2O7S3
CAS Number: 104376-79-6
Common Names: Ceftriaxone Sodium, Rocephin
Recommended Use: Antibiotic, pharmaceutical applications
Manufacturer: [Manufacturer address and emergency contact]
Packaging Description: Supplied as lyophilized powder in sterile vials
Synonyms: Ceftriaxone Disodium Salt, Rocephin Injection
Contact Information: [Phone number, email for emergencies]

Hazard Identification

GHS Classification: Eye irritation (Category 2A), sensitization (Category 1), specific target organ toxicity (repeated exposure, Category 2)
Signal Word: Warning
Hazard Statements: Causes serious eye irritation, may cause allergic skin reaction, may cause respiratory sensitization, may cause damage to organs through prolonged or repeated exposure
Pictograms: Exclamation mark, Health hazard
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, use personal protective equipment, do not eat or drink while handling

Composition / Information on Ingredients

Ceftriaxone Sodium: 98-100%
Water for Injection (Sterile): As excipient / vehicle
Impurities and stabilizers: May contain trace stabilizers or buffer agents, not exceeding 2%

First Aid Measures

General Advice: Seek medical attention if symptoms occur or persist
Eyes: Rinse with plenty of water for at least 15 minutes, hold eyelids open, seek medical care
Skin Contact: Remove contaminated clothing, wash skin with soap and water, seek care if irritation develops
Inhalation: Move victim to fresh air, support breathing if necessary, get medical help if symptoms persist
Ingestion: Rinse mouth, do not induce vomiting unless directed by medical personnel, seek immediate attention
Most Important Symptoms/Effects: Allergic reactions, rash, eye irritation, breathing difficulty, gastrointestinal discomfort

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray
Special Hazards: May produce hazardous decomposition products such as carbon oxides, sulfur oxides, nitrogen oxides
Protective Equipment: Fire fighters should wear self-contained breathing apparatus and protective clothing, avoid dust formation
Precautions for Firefighters: Move containers from fire area if possible, use water spray to keep fire-exposed containers cool, stay upwind to avoid fumes

Accidental Release Measures

Personal Precautions: Wear suitable gloves, lab coat, eye protection, NIOSH-approved respirator where necessary
Spill Cleanup Methods: Sweep up without creating dust, keep in closed containers for disposal, ventilate area
Environmental Precautions: Prevent spillage from entering drains, surface, or ground water, inform authorities if product enters environment
Decontamination: Clean spill location with suitable disinfectant, dispose waste in accordance with regulations

Handling and Storage

Safe Handling: Use in well-ventilated location, avoid contact with skin, eyes, and clothing, minimize dust creation
Storage Conditions: Store at 20-25°C in a dry place protected from moisture and light, keep container tightly closed
Incompatible Materials: Strong oxidizing agents, acids, bases
Special Requirements: Store away from food and beverages, restrict access to trained personnel only

Exposure Controls and Personal Protection

Exposure Limits: No established OSHA/ACGIH exposure limits for ceftriaxone sodium; control exposure as low as reasonably achievable
Engineering Controls: Use fume hood, local exhaust, or other engineering controls to keep airborne levels low
Eye Protection: Chemical safety goggles with side shields
Hand Protection: Nitrile or latex gloves
Skin Protection: Long-sleeved lab coat or coveralls
Respiratory Protection: NIOSH certified respirator when ventilation inadequate or during spill cleanup
Hygiene Measures: Wash thoroughly after handling, change contaminated clothing, do not eat or drink while working

Physical and Chemical Properties

Appearance: White to yellowish, crystalline powder
Odor: Odorless
pH (1% solution): 6.0 - 8.0
Melting Point: Decomposes above 200°C
Solubility: Freely soluble in water, nearly insoluble in organic solvents
Molecular Weight: 661.6 g/mol
Boiling Point: Not applicable (decomposes)
Flash Point: Not applicable
Vapor Pressure: Not applicable
Density: Not established for powder form
Partition Coefficient (Log Kow): Not available

Stability and Reactivity

Chemical Stability: Stable if stored and handled under recommended conditions, moisture and heat sensitive
Hazardous Reactions: No hazardous polymerization expected under normal storage and use
Incompatible Materials: Strong oxidizing agents, acids, bases
Decomposition Products: Carbon oxides, sulfur oxides, nitrogen oxides under fire conditions
Reactivity: Avoid strong acids or bases, incompatibility may cause breakdown and release of hazardous products

Toxicological Information

Acute Toxicity: LD50 (oral, rat) > 5000 mg/kg, low acute toxicity via oral, dermal, and inhalation routes
Skin Corrosion/Irritation: May cause mild to moderate skin irritation
Eye Damage/Irritation: Causes serious eye irritation
Respiratory/Skin Sensitization: May cause allergic reactions in susceptible individuals, particularly via injection or inhalation
Germ Cell Mutagenicity: Not classified as mutagenic based on available animal data
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, OSHA
Reproductive Toxicity: No reproductive or developmental effects observed in animal studies at therapeutic doses
Specific Target Organ Toxicity: May impact renal function at high doses, hypersensitivity a documented risk in clinical settings

Ecological Information

Ecotoxicity: Ceftriaxone is moderately toxic to aquatic organisms at high concentrations; care in waste management recommended
Environmental Fate: Degrades slowly in soil and water, persistent in environmental media
Bioaccumulation Potential: Not expected to bioaccumulate significantly
Mobility in Soil: High water solubility suggests good mobility; potential for leaching into groundwater exists
Other Adverse Effects: May contribute to development of antibiotic resistance in microorganisms if released into the environment

Disposal Considerations

Waste Disposal Methods: Place contaminated materials in clearly marked container for landfill or incineration, follow federal, state, and local regulations
Unused Product: Incinerate where permitted, do not dispose to wastewater or natural environment
Container Disposal: Rinse thoroughly, dispose as hazardous chemical waste
Precautions: Do not mix with household garbage, do not flush down drain or toilet, coordinate with licensed chemical waste disposal service

Transport Information

UN Number: Not classified as dangerous for transport
Transport Hazard Class: Not regulated under ADR/RID/IMDG/IATA
Packing Group: Not assigned
Proper Shipping Name: Ceftriaxone Sodium - Sterile
Special Precautions: Protect from heat, moisture, and physical damage during transit, ship in tightly sealed original containers

Regulatory Information

U.S. Regulations: Not listed as hazardous by OSHA, not regulated by SARA Title III; subject to FDA guidelines as a prescription drug
European Union: Not classified as hazardous under CLP guidelines; subject to medical product regulations
Other International Regulations: Complies with listing under international pharmacopeias; consult customs or health authorities for country-specific import/export restrictions
Federal Drug Administration (FDA): Approved prescription medicine, restrictions apply to handling and distribution
Worker Protection: Compliance with OSHA Laboratory Standard (29 CFR 1910.1450) advised, safe handling as pharmaceutical agent required in all workplaces