Product Name: Levofloxacin Lactate
Chemical Formula: C18H20FN3O4·C3H6O3
Common Synonyms: Levofloxacin hemihydrate, Levofloxacinum lactas
CAS Number: 100986-85-4 (Levofloxacin), 79-33-4 (Lactic Acid)
Recommended Use: Antibiotic agent in pharmaceutical applications
Manufacturer: Refer to packaging information
Emergency Phone: Local poison control center or medical professional
GHS Classification: Eye irritation, skin sensitizer, acute toxicity (oral)
Hazard Statements: May cause respiratory irritation, skin sensitization, serious eye damage, and gastrointestinal upset.
Pictograms: Exclamation mark, health hazard
Signal Word: Warning
Precautionary Statements: Avoid inhalation, use protective equipment, wash hands thoroughly after handling, avoid contact with eyes, skin, and clothing.
Routes of Entry: Inhalation, ingestion, skin and eye contact
Main Ingredient: Levofloxacin Lactate
Chemical Content: Levofloxacin 98%–100%, Lactic Acid balance
Impurities: Water, traces of related substances, residual solvents below regulatory limits
Molecular Weight: Approximately 420 g/mol
Inhalation: Move person to fresh air, monitor breathing, seek medical advice if symptoms persist.
Skin Contact: Remove contaminated clothing, wash skin with soap and plenty of water for at least 15 minutes, seek medical attention if irritation continues.
Eye Contact: Hold eyelids open, rinse with plenty of water for at least 15 minutes, remove contact lenses if possible, seek immediate medical attention.
Ingestion: Rinse mouth with water, do not induce vomiting unless instructed by medical personnel, seek medical help promptly.
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam recommended for small fires.
Specific Hazards: Emits toxic fumes of hydrogen fluoride, nitrogen oxides under fire conditions.
Protective Equipment for Firefighters: Use self-contained breathing apparatus, full protective clothing to prevent contact with skin and eyes.
Explosion Hazards: Not classified as explosive, product can decompose at high temperatures to produce dangerous vapors.
Personal Protection: Wear gloves, protective clothing, and eye protection. Avoid dust formation and contact with skin.
Containment: Sweep up spills without generating dust, place in suitable closed containers for disposal.
Cleanup Methods: Ventilate area, clean surfaces with water and detergent, do not allow material to enter drains or waterways.
Environmental Precautions: Prevent further leakage or spillage if safe to do so. Notify authorities if product contaminates water or soil.
Precautionary Handling: Use in well-ventilated areas, avoid breathing dust, minimize handling, wash hands thoroughly after use.
Storage Conditions: Store in tightly closed containers in a cool, dry, and well-ventilated place, away from incompatible materials such as strong oxidizers and acids.
Storage Temperature: Maintain storage temperature below 30°C, protect from moisture and light.
Special Precautions: Segregate from food and feedstuffs, keep out of reach of unauthorized personnel.
Occupational Exposure Limits: No specific permissible exposure limits established, use pharmaceutical exposure controls where applicable.
Engineering Controls: Local exhaust ventilation, dust extraction systems in handling areas.
Personal Protective Equipment: Safety glasses or chemical splash goggles, impervious gloves (nitrile or neoprene), laboratory coats, respiratory protection if airborne dust may be generated.
Hygiene Measures: Do not eat, drink, or smoke while handling, wash hands and exposed areas with soap and water after handling.
Appearance: White to pale yellow crystalline powder
Odor: Odorless
pH (1% Solution): 4–6
Melting Point: 220–225°C (decomposes)
Boiling Point: Not applicable (decomposes)
Solubility in Water: Freely soluble
Vapor Pressure: Not applicable
Density: 1.5–1.7 g/cm³
Partition Coefficient (log Pow): 0.7–1.0
Flash Point: Not flammable
Evaporation Rate: Not determined
Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Excessive heat, direct sunlight, moisture
Incompatible Materials: Strong oxidizing agents, strong acids
Hazardous Decomposition Products: Formation of hydrogen fluoride, nitrogen oxides, carbon monoxide during decomposition
Polymerization: Not known to occur
Acute Toxicity: Low acute toxicity by oral and dermal routes, LD50 (oral, rat): 2000–5000 mg/kg
Chronic Toxicity: Repeated exposure may affect liver, kidneys, and may have neurological effects with excessive inhalation or ingestion
Skin Irritation: Mild to moderate irritant on prolonged or repeated contact
Eye Irritation: May cause severe irritation, redness, and pain
Sensitization: May cause allergic skin reactions in sensitive individuals
Mutagenicity: Some studies indicate potential for mutagenicity at high doses
Other Effects: Dizziness, headache, gastrointestinal symptoms such as nausea and diarrhea in accidental exposure
Ecotoxicity: Potential toxicity to aquatic organisms, limited data available
Persistence and Degradability: Partially biodegradable, degradation occurs slowly in the environment
Bioaccumulation: Product does not show significant potential for bioaccumulation
Mobility in Soil: Moderately mobile, may contaminate surface and groundwater if released in large quantities
Environmental Precautions: Prevent release to waterways, soil, and sewers to reduce impact on aquatic ecosystems
Waste Disposal Methods: Dispose in accordance with local, regional, or national regulations as pharmaceutical waste.
Contaminated Packaging: Triple rinse containers, offer for chemical recycling where possible, incinerate only in a controlled environment.
Special Precautions: Do not dispose into drains or natural environment, inform local waste regulators about the hazardous nature of the substance.
UN Number: Not classified as hazardous for transport
Proper Shipping Name: Levofloxacin Lactate or pharmaceutical intermediate
Hazard Class: Not regulated
Packing Group: Not applicable
Transport Precautions: Keep container tightly closed, protect from physical damage, avoid water contamination during transport
Regulatory Status: Subject to prescription medicine regulations, not a controlled substance
International Inventories: Listed in REACH (EU), TSCA (US), DSL (Canada) for research and pharmaceutical use
Workplace Safety: Complies with OSHA Hazard Communication Standard in the US, EU and GHS standards globally
WHMIS Classification (Canada): D2B (Toxic Material Causing Other Toxic Effects)
SARA Title III: Not subject to reporting under SARA Title III Sections 302, 304, or 313
