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Product Name: Ceftiofur Sodium - Sterile Solvent Powder
Synonyms: Sodium salt of ceftiofur, Sterile ceftiofur sodium, Injectable ceftiofur sodium
CAS Number: 68496-25-9
Recommended Use: Veterinary antimicrobial, prescription-only medication intended for parenteral use in animals
Manufacturer: Pharmaceutical companies producing veterinary medications under license; users should refer to packaging for specific supplier details
Emergency Contact: National Poison Control Center, regional hazardous materials numbers, or local emergency medical services
UN Number: Not classified under a specific UN number for transport
GHS Classification: Respiratory sensitizer (Category 1), Skin sensitizer (Category 1), Eye irritation (Category 2), Target organ toxicity single exposure (Category 3)
Label Elements: Pictograms indicating respiratory and skin sensitization, warning symbol for irritant
Hazard Statements: Causes respiratory irritation, may cause allergic skin reactions; susceptible individuals might experience severe hypersensitivity responses, especially with direct contact or inhalation of powder particles
Precautionary Statements: Avoid breathing dust or mist, wash skin thoroughly after handling; wear protective gloves, clothing, and eye or face protection; in case of inadequate ventilation, use respiratory protection
Potential Health Effects: Exposure through skin contact leads to swelling, redness, or delayed allergic reactions; inhalation may trigger asthma-like symptoms, persistent cough, or breathing difficulties; accidental exposure to eyes produces pain and inflammation
Environmental Hazards: No designated environmental hazard, but antibiotic residues entering the environment contribute to antimicrobial resistance development in soil and waterborne bacteria
Ceftiofur Sodium: Active ingredient, cephalosporin class antibiotic, approximate content 95-98% by weight
Inactive Ingredients: Sodium carbonate or sodium bicarbonate (buffering), sterile diluent in associated vial for reconstitution
Impurities/Additives: Substances resulting from manufacturing, most being below 1% concentration, not expected to pose additional risks beyond parent compound; specific impurity levels can be verified by consulting latest pharmacopeia
Form: White to off-white powder, reconstituted with sterile water for injection
Molecular Formula: C19H16N5NaO7S3
Molecular Weight: 554.54 g/mol
Inhalation: Move exposed person to fresh air immediately; keep at rest; if symptoms develop, such as coughing, shortness of breath, or chest tightness, seek medical attention without delay
Skin Contact: Remove contaminated clothing; rinse skin under running water for at least fifteen minutes; consult a healthcare provider for signs of irritation, itching, swelling, or blistering; treat allergic reactions promptly
Eye Contact: Flush exposed eyes with gentle, continuous water flow for a minimum of fifteen minutes; ensure eyelids are held open during rinsing; medical evaluation required for persistent discomfort, redness, or pain
Ingestion: Do not induce vomiting; give plenty of water if patient is conscious; contact healthcare provider or poison control immediately, keeping packaging available for reference
Most Important Symptoms: Allergic reactions (hives, swelling, anaphylaxis), respiratory distress, eye irritation, gastrointestinal upset (if ingested unintentionally)
Note for Physicians: Provide symptomatic and supportive treatment; monitor for late onset hypersensitivity, advise against future cephalosporin exposure in sensitized persons
Suitable Extinguishing Media: Use carbon dioxide, dry chemical powder, alcohol-resistant foam, or water spray for surrounding fire; avoid direct high-pressure streams on undeveloped powder
Unsuitable Extinguishing Media: Do not use water jets directly on the product since they may disperse powder into the air and increase exposure risk
Specific Fire Hazards: Powder does not sustain combustion, but decomposition at high temperature may release hazardous fumes such as nitrogen oxides, sulfur oxides, and carbon oxides
Special Protective Equipment: Firefighters should use self-contained breathing apparatus (SCBA) along with chemical-resistant protective gear; evacuate personnel from area if fumes are present
Firefighting Advice: Cool surrounding containers with water spray; avoid inhaling combustion products; keep upwind of fire scene
Personal Precautions: Evacuate unprotected or untrained personnel from the spill area; restrict access except for properly protected response team; wear suitable personal protective equipment (PPE) such as gloves, gowns, and filtering masks
Environmental Precautions: Prevent dispersed powder from entering drains, surface water, soil, or sewers; gather spill residues promptly and dispose of them through approved means
Methods for Cleanup: Avoid sweeping which can generate dust; use moistened absorbent material or vacuum equipped with HEPA filter for powder collection; thoroughly clean area with copious amounts of water and neutral detergent
Precaution During Handling Spills: Minimize agitation during cleaning; double-bag collected waste in sealed, sturdy plastic containers for disposal
Safe Handling: Train personnel in pharmaceutical dust safety and allergic response protocols; use biological safety cabinet or local exhaust; never eat, drink, or smoke in handling areas; wash hands thoroughly after reconstitution or contact
Storage Conditions: Store powder and solvent vials tightly closed in original labeled containers; keep in a cool (2–8°C), dry, well-ventilated area, away from sunlight, moisture, strong oxidizers, acids, and incompatible materials
Incompatibilities: Avoid contact with strong oxidizers, acids, and alkalis as stability might break down, with active principal degrading to less active or potentially toxic forms
Special Storage Requirements: Restrict access to authorized staff; maintain appropriate temperature logs; keep away from unauthorized persons, children, and animals
Packaging Materials: Use original supply vials until full use; do not transfer into unapproved containers; ensure all packaging is clearly marked with hazard and identity label
Engineering Controls: Provide sufficient mechanical ventilation, local exhaust, or fume hoods to limit airborne concentration below occupational safety limits; validated containment for pharmaceutical compounds should be in place
Exposure Limits: Exact occupational exposure limits (OELs) are not established, but take all reasonable action to minimize exposure, especially for sensitized personnel
Personal Protective Equipment: Chemical-resistant, disposable gloves; safety goggles with side shields or full face protection; lab coats or impervious coveralls; type N95 or higher respirators in situations of powder liberation or insufficient ventilation
Hygiene Measures: Thorough hand washing before eating, drinking, or leaving work area; change contaminated clothing promptly; do not touch face, eyes, or exposed skin during handling
Environmental Protection: Ensure all air discharges are filtered before exhaust; monitor and reduce accidental releases from process suites or preparation areas
Appearance: White to pale yellow powder, no pronounced odor
Solubility: Water-soluble, less soluble in organic solvents such as ethanol or acetone
pH (solution): Usually in the range of 6.0–8.5 upon reconstitution
Melting Point: Decomposes over 200°C, not described by a fixed melting point
Boiling Point: Not applicable; decomposes
Flash Point: Not flammable in powder form
Vapor Pressure: Negligible under standard conditions
Density: 1.4–1.5 g/cm3
Partition Coefficient (log Kow): Data limited; not expected to bioaccumulate owing to water solubility
Other Properties: Sensitive to moisture; avoid strong acids or bases; chemically unstable at extreme pH or elevated temperature
Chemical Stability: Maintains integrity under recommended storage and handling conditions; loss of activity and degradation products result from prolonged exposure to heat, moisture, or UV light
Reactivity: May react with reducing agents, strong oxidizing agents, or acids, causing breakdown of beta-lactam ring
Hazardous Decomposition Products: Nitrogen oxides, sulfur oxides, carbon oxides, and other volatile compounds under fire or severe thermal stress
Polymerization: Does not polymerize under normal conditions
Exposure to Incompatible Materials: May lead to rapid degradation and increased risk of loss of antibiotic activity and possible formation of toxic irritant fumes
Shelf Life: Product retains stability up to expiry date if unopened and stored as per manufacturer’s recommendations
Acute Toxicity: Oral LD50 range in rodents is over 5000 mg/kg, indicating low acute oral toxicity; parenteral toxicity is higher due to immune response
Routes of Exposure: Creates risks if inhaled, ingested, or through dermal or ocular contact
Symptoms: Allergic reactions in sensitized individuals (rash, hives, respiratory symptoms); rarely, severe anaphylactic response
Chronic Effects: Repeated exposure increases likelihood of developing allergic skin or respiratory conditions; no evidence of carcinogenicity, mutagenicity, or reproductive toxicity in animal studies reported to date
Target Organs: Immune system (sensitization), mucous membranes, respiratory tract
Medical Conditions Aggravated: Asthma, atopic dermatitis, previous beta-lactam hypersensitivity
Other Risks: Unintentional animal exposure leads to adverse drug reactions including gastrointestinal or hematologic effects
Acute Aquatic Toxicity: Possible harmful effect on aquatic microorganisms and algae; antibiotic residues in water contribute to ecosystem-level disturbances by promoting antibiotic resistance in environmental bacteria
Persistence and Degradability: Breakdown in soil and water environments occurs but can be slow; beta-lactams degrade more rapidly under high temperature and sunlight
Bioaccumulation: Not expected due to poor partitioning into organic phases; hydrophilic properties reduce uptake by aquatic or terrestrial organisms
Mobility in Soil: Soluble and potentially mobile if released into groundwater or surface water systems
Other Adverse Effects: Pharmaceutical residues may disrupt beneficial soil and aquatic microflora following repeated or unregulated disposal events
Regulatory Attention: Environmental release regulated under pharmaceutical waste and hazardous materials legislation to protect water quality and biodiversity
Waste Disposal Methods: Treat all unused powder, contaminated items, and residues as pharmaceutical hazardous waste; do not flush into sewer, surface water, or municipal landfill; follow current local, regional, and national disposal guidelines
Recommended Disposal Practice: Incinerate under controlled, high-temperature conditions in a permitted pharmaceutical waste facility; use licensed waste haulers and record-keeping for traceability
Container Handling: Triple-rinse and puncture empty vials before discarding as non-hazardous waste if regulations permit; otherwise, dispose as hazardous waste
Precautions: Avoid aerosolization or dust generation during packaging; seal waste in robust, leakproof bags or containers
Do Not Dispose: In household trash, agricultural land, or by dilution into drains or septic systems
UN Classification: Not regulated as a hazardous substance under commonly applied UN Hazardous Materials codes
Transport Hazard Class: Not assigned; handle as a prescription veterinary substance
Proper Shipping Name: Ceftiofur Sodium (for identification purposes only)
Packing Group: Not assigned
Labeling Requirements: Mark packaging for biological/antibiotic content; maintain cool chain if required by supplier
Transport Precautions: Avoid crushing containers; protect from moisture and sunlight during loading, unloading, and transit; ensure all packages meet regulatory requirements for finished pharmaceuticals during shipment
US Regulation: FDA-approved prescription animal drug under Federal Food, Drug, and Cosmetic Act; worker protection standards under OSHA; subject to controlled substance tracking and waste framework
European Union: Regulated as veterinary medicine; EC Directive 2001/82/EC; Workplace exposure standards not individually assigned but covered by REACH substance regulations
Canada: Controlled under Health Canada’s Food and Drugs Act, Environmental Protection Act for antibiotic residues, and provincial hazardous substance rules
Australia and New Zealand: Regulated as S4 Restricted Substance (prescription animal remedy); environmental controls under respective Environment Protection agencies
Workplace Labelling: Requires product identity, supplier information, WHMIS/CLP pictograms, hazard and precautionary statements in local language
Other International: Classified as pharmaceutical for professional use only; restricted veterinary access in numerous countries, traceability and waste controls mandated to limit resistance development and environmental entry
