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Product Name: Cefuroxime Axetil
Synonyms: Cefuroxime 1-acetoxyethyl ester; Zinnat; Ceftin
Chemical Formula: C20H22N4O10S
Molecular Weight: 510.47 g/mol
CAS Number: 64544-07-6
Recommended Use: Pharmaceutical antibiotic, cephalosporin class
Manufacturer: Varies by country
Emergency Contact: Local poison control or medical emergency hotline
GHS Classification: Not classified as hazardous according to OSHA Hazard Communication Standard
Potential Health Effects: May cause allergic reactions in sensitive individuals; eye, skin, and respiratory irritation possible; risk of sensitization after repeated contact
Signal Word: None assigned; handle with care
Hazard Statements: Allergen to hypersensitive individuals; not for persons with cephalosporin allergy
Precautionary Statements: Avoid inhaling dust; prevent skin or eye contact; do not ingest unless prescribed
Routes of Exposure: Eye, skin, respiratory, ingestion
Cefuroxime Axetil: 96-100% by weight
Excipients: Trace amounts possible, depending on formulation; includes microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate in finished tablets
Impurities: Less than 1%, typically identified and controlled in pharmaceutical formulations
Eye Contact: Rinse thoroughly with water for several minutes; remove contact lenses if present and easy; medical attention recommended if irritation persists
Skin Contact: Wash with soap and water; seek medical help if redness or irritation develops
Ingestion: Rinse mouth; give water to dilute; do not induce vomiting; call a doctor or poison center without delay
Inhalation: Move to fresh air; support breathing if needed; consult medical care if symptoms such as coughing or shortness of breath develop
Allergic Reactions: Seek immediate help if swelling, rash, difficulty breathing or signs of anaphylaxis appear
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, foam
Unsuitable Media: Do not use high-pressure water jets
Special Hazards: No expected unusual fire or explosion risks from pure substance; toxic fumes possible: carbon oxides, nitrogen oxides, sulfur oxides, hydrogen chloride
Protective Equipment for Firefighters: Full protective gear and self-contained breathing apparatus; prevent runoff from firefighting to water bodies or sewers
Personal Precautions: Wear gloves, goggles, dust mask or respirator suited for powders
Environmental Precautions: Prevent entry into sewers, drains, surface waters
Spill Cleanup Methods: Avoid dust generation; collect with inert absorbent material; sweep up and transfer to an appropriate waste container; ventilate area during cleanup; clean area with water and detergent
Safe Handling: Work in well-ventilated spaces; avoid creating or breathing dust; wash hands after handling; no food, drink, or smoking in work area
Safe Storage: Store in a cool, dry place away from sunlight, heat, and moisture; keep container tightly closed; do not store near strong oxidizers or acids; store at controlled room temperature as specified by manufacturer
Incompatibilities: Strong acids, strong oxidizers, alkali metals
Occupational Exposure Limits: No specific OSHA, ACGIH, or EU limits established for active ingredient
Engineering Controls: Ventilation with local exhaust; keep airborne levels low
Personal Protective Equipment: Gloves (nitrile or latex), safety goggles, lab coats or gowns, powder mask or respirator if dust risk
Hygiene Measures: Wash hands thoroughly after handling; remove contaminated clothing before leaving the workplace
Appearance: White to off-white crystalline powder
Odor: None detected
Odor Threshold: Not determined
pH: Neutral to slightly acidic (for aqueous suspension)
Melting Point: Decomposes before melting at about 134-138°C
Boiling Point: Not applicable (decomposes)
Flash Point: Not flammable
Solubility: Practically insoluble in water; soluble in alcohol and acetone
Partition Coefficient: log Kow estimated −0.2 (very low bioaccumulation potential)
Vapor Pressure: Not applicable
Density: 1.6 g/cm³ (approximate)
Stability: Stable in dry form, hydrolyzes in water
Viscosity: Not available
Chemical Stability: Stable under recommended storage conditions but degrades in water or high humidity environments
Reactivity: No hazardous reactivity expected under normal conditions
Incompatible Materials: Acidic or alkaline compounds, oxidizing agents
Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur compounds, hydrogen chloride under fire conditions
Hazardous Polymerization: Not known to occur
Likely Routes of Exposure: Skin, eye, inhalation, ingestion
Acute Toxicity: Oral LD50 in rodents over 5,000 mg/kg; low acute toxicity for humans
Chronic Toxicity: No chronic toxicity in approved medical uses; repeated high exposure may cause liver, kidney changes in animal studies
Allergic Reactions: Urticaria, anaphylaxis in sensitive individuals
Contact Hazards: Mild skin or eye irritation
Carcinogenicity: Not listed as carcinogen by IARC, NTP, or OSHA
Mutagenicity: No evidence of genetic damage in standard animal tests
Reproductive Effects: Animal studies show no adverse effects at approved doses; insufficient data in humans
Sensitization: Possible with repeated or prolonged contact, particularly for exposed workers
Environmental Impact: Not persistent; may degrade in natural environments
Mobility: Limited because of poor water solubility
Bioaccumulation: Unlikely based on low partition coefficient
Aquatic Toxicity: Low acute toxicity expected to aquatic organisms; may affect microbial populations in wastewater
Degradability: Slowly biodegradable under aerobic conditions; faster under sunlight
Other Information: Antibiotic activity in released drug may disrupt local bacteria; do not allow large amounts to reach sewers or waterways
Waste Disposal Method: Place in properly labeled pharmaceutical waste container; incinerate in accordance with local, regional, or national regulations
Unused Product: Return to pharmacy or appropriate facility for safe disposal
Contaminated Packaging: Triple rinse containers; dispose of in approved landfill or incineration facility
Environmental Precautions: Do not dispose of product in drains, sewers, or environment
UN Number: Not regulated for transport
Proper Shipping Name: Not classified as dangerous for transport
Transport Hazard Class: Not applicable
Packing Group: Not assigned
Special Transport Precautions: Prevent breakage of packaging; store away from food, feed, and incompatible materials during transport
Marine Pollutant: No
U.S. Regulations: Not listed under CERCLA, SARA Title III, or California Prop 65
EU Regulations: Classified as medicinal product; meets REACH and CLP standards
WHMIS Classification (Canada): Pharmaceutical product, not controlled
OSHA Hazard Communication Standard: Not classified as hazardous chemical
Other Regulatory Status: Prescription medication; production and handling overseen by national health authorities
