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Product Name: Levofloxacin; Levofloxacin Hydrate
Chemical Formula: C18H20FN3O4 (Levofloxacin); C18H20FN3O4•xH2O (Levofloxacin Hydrate)
Synonyms: (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid
Recommended Use: Pharmaceutical ingredient, research and analytical testing
Manufacturer: Pharmaceutical manufacturers, laboratories
Contact Number for Emergency: Provided by supplier, check label or company website for country-specific information
CAS Number: 100986-85-4 (Levofloxacin); Hydrate forms vary
Hazard Classification: Eye irritant, potential respiratory system irritant, skin sensitizer, possible allergic reactions
Signal Word: Warning
Hazard Statements: May cause moderate eye irritation, can provoke respiratory irritation if dust is inhaled, can cause redness or skin rash, possible photosensitivity
Precautionary Statements: Avoid contact with skin, eyes, and clothing; handle in well-ventilated areas; do not eat, drink, or smoke during use
GHS Symbols: Exclamation mark (irritant)
Main Ingredient: Levofloxacin (purity typically above 98%)
Hydrate Content: Varies depending on form, commonly Levofloxacin Monohydrate
Impurities: Minor synthetic byproducts, less than 1% total
Additives: No intentional additives; check formulation specifics for tablets or solutions
Inhalation: Move the person to fresh air; seek medical attention if symptoms such as cough or shortness of breath persist
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes; remove contact lenses if present; seek medical help if irritation continues
Skin Contact: Wash thoroughly with soap and water; remove contaminated clothing and wash before reuse
Ingestion: Rinse mouth; provide water if the person is conscious; do not induce vomiting; seek prompt medical attention
Suitable Extinguishing Media: Water spray, foam, dry chemical powder, carbon dioxide
Hazardous Combustion Products: May give off toxic fumes such as nitrogen oxides, hydrogen fluoride, carbon monoxide, carbon dioxide
Protective Equipment: Firefighters wear self-contained breathing apparatus and full protective gear
Special Precautions: Isolate the area, keep upwind to avoid inhaling smoke or fumes
Personal Precautions: Wear gloves, dust mask, eye protection, and lab coat
Environmental Precautions: Avoid letting product enter drains or waterways
Cleanup Methods: Sweep up material using wet methods to minimize dust; collect in appropriate container for disposal; ventilate area
Decontamination: Wash area with plenty of water after removal of material; do not allow wash-off into sewers
Handling: Use only in well-ventilated areas; avoid breathing dust; prevent contact with skin, eyes, and clothing; do not handle in areas where food is prepared; follow good hygiene practices
Storage: Store in tightly closed original container; keep out of direct sunlight; maintain dry, cool (15-30°C) conditions; protect from moisture; keep away from incompatible substances such as acids and strong oxidizers
Incompatibilities: Strong acids, bases, oxidizing agents
Engineering Controls: Use local exhaust ventilation, fume hood
Personal Protective Equipment (PPE): Lab coat, nitrile gloves, safety goggles, dust mask or respirator if dusts are present
Hygiene Measures: Wash hands, arms, and face thoroughly after handling; no eating, drinking, or smoking in the workplace
Exposure Limits: Not established specifically for levofloxacin; use pharmaceutical industry best practices and country-specific occupational health limits
Appearance: Pale yellow to light yellow crystalline powder
Odor: Odorless or mild odor
pH (1% aqueous solution): 3.8 - 5.8
Melting Point: Approximately 220-225°C (decomposition)
Solubility: Freely soluble in water and acids, slightly soluble in ethanol, nearly insoluble in ether
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Not applicable
Partition Coefficient (log Pow): Approximately -0.41
Bulk Density: 0.3 - 0.5 g/cm³
Stability: Stable under recommended storage and handling conditions
Thermal Decomposition: Decomposes when heated above 220°C
Hazardous Reactions: No dangerous reactivity with common materials under normal use
Incompatible Materials: Strong acids, bases, oxidizing or reducing agents
Hazardous Decomposition Products: May generate toxic fumes in fire, including fluoride and nitrogen oxides
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg; skin and respiratory toxicity are low in animal models
Irritation: May cause mild to moderate irritation to skin, eyes, mucous membranes
Chronic Toxicity: Prolonged or repeated exposure can cause allergic sensitization; high doses linked to tendon disorders in clinical use
Carcinogenicity: Not suspected of being carcinogenic in humans based on available data
Mutagenicity: Negative in standard bacterial and mammalian cell assays
Reproductive Toxicity: Not known to interfere with fertility at therapeutic doses; animal studies show no major developmental impact
Other Health Effects: Risk of antimicrobial resistance if misused; medical supervision required
Ecotoxicity: Toxic to aquatic life at low concentrations; not easily biodegradable
Persistence and Degradability: Moderate environmental persistence; limited degradation in natural environments
Bioaccumulative Potential: Low to moderate, based on partition coefficient
Mobility in Soil: Moderate; potential for groundwater contamination in high concentrations
Other Adverse Effects: Presents risk of developing antibiotic resistance in environmental bacteria
Waste Treatment Methods: Dispose through certified chemical waste disposal contractor
Product Disposal: Incinerate in controlled facility if possible; do not discharge to the environment
Container Disposal: Rinse with water, destroy labels, and discard containers according to local regulations
Regulations: Comply with local, regional, national, and international waste regulations
UN Number: Not classified as hazardous for transport
Transport Hazard Class: Not regulated under ADR, IMDG, IATA
Packing Group: Not assigned
Environmental Hazards: Avoid release during transport; prevent package breakage and spillage
Special Precautions: Use appropriate, clearly labeled packaging; avoid exposure to heat and moisture during transport
US Regulations: Listed as a prescription drug; not listed under OSHA, TSCA, SARA
European Regulations: Registration under REACH for bulk handling; subject to medicinal product directives
International Inventories: Not included in general chemical inventories, restricted to pharmaceutical regulatory pathways
Other Requirements: Observe occupational exposure standards and prescription control laws in healthcare settings; monitor for updates in antimicrobial stewardship policies
