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Product Name: Levofloxacin Hydrochloride
Chemical Formula: C18H20FN3O4·HCl
Chemical Family: Fluoroquinolone Antibiotic
CAS Number: 138199-71-0
Manufacturer: Refer to supplier for detailed contact information
Recommended Use: Pharmaceutical ingredient, antibacterial treatment
Synonyms: Levaquin, (-)-(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 monohydrochloride
Health Hazards: May cause irritation to eyes, skin, and respiratory tract; potential for allergic reactions
Acute Effects: Eye redness, skin rash, respiratory distress, headache, gastrointestinal nausea, vomiting
Chronic Effects: Possible kidney and liver effects after prolonged or repeated exposure
Environmental Hazards: Hazardous to aquatic life with long lasting effects
GHS Classification: Eye Irritant Category 2A, Skin Sensitizer Category 1, Acute Aquatic Toxicity Category 3
Signal Word: Warning
Pictograms: Exclamation mark, Environment
Precautionary Statements: Avoid contact with skin and eyes; avoid release into the environment
Chemical Name: Levofloxacin Hydrochloride
Concentration: Greater than 99%
Impurities: Trace organic impurities below 1% as total
Additives: None
Inhalation: Move to fresh air; seek medical attention if symptoms develop like coughing, difficulty breathing, or dizziness
Skin Contact: Remove contaminated clothing; wash skin thoroughly with soap and water; consult a doctor if irritation persists
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy to do; continue rinsing; seek medical attention
Ingestion: Rinse mouth with water; do not induce vomiting; seek immediate medical attention
Notes for Doctor: Symptomatic supportive treatment; no specific antidote known
Suitable Extinguishing Media: Water spray, dry powder, carbon dioxide, foam
Unsuitable Extinguishing Media: High volume water jet
Special Hazards: May emit toxic fumes of hydrogen chloride, nitrogen oxides, and fluorine compounds on combustion
Protective Equipment for Firefighters: Self-contained breathing apparatus and protective clothing
Fire Fighting Instructions: Isolate area, keep upwind, avoid breathing smoke or fumes; move containers from fire area if safe; prevent runoff from entering drains
Personal Precautions: Wear appropriate protective equipment; avoid generating dust; ventilate area
Environmental Precautions: Prevent entry into drains, sewers, or waterways; avoid release to the environment
Cleanup Methods: Sweep or scoop into a suitable container for disposal; decontaminate spill surface with detergent and water
Disposal: Dispose as hazardous waste in accordance with local, national, and international regulations
Handling: Use only in well-ventilated areas; handle according to good industrial hygiene practices; avoid inhalation and contact with skin or eyes
Storage: Keep container tightly closed, in a cool, dry, well-ventilated area; protect from light, moisture, and incompatible materials
Incompatibilities: Strong acids, bases, strong oxidizers
Engineering Controls: Use local exhaust and general ventilation; handle in a fume hood if dust generation likely
Exposure Limits: Occupational exposure limits not established for this substance
Personal Protective Equipment: Safety goggles, impervious gloves, lab coat, and respiratory protection for dust
Hygiene Measures: Wash hands thoroughly after handling; do not eat, drink, or smoke during use
Appearance: White to light yellow crystalline powder
Odor: Odorless
pH (1% solution): 3.0 - 5.0
Melting Point: 233°C – 239°C (decomposition)
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Freely soluble in water, slightly soluble in ethanol
Vapor Pressure: Not determined
Partition Coefficient (log Pow): -0.41 (estimated)
Flash Point: Not applicable
Autoignition Temperature: Not determined
Chemical Stability: Stable under recommended storage conditions
Possibility of Hazardous Reactions: No dangerous reactions known under normal conditions
Conditions to Avoid: Excessive heat, moisture, direct sunlight
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: Hydrogen chloride, nitrogen oxides, fluorinated compounds
Acute Toxicity: Oral LD50 (rat) > 2000 mg/kg
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms: Gastrointestinal disturbances, dizziness, allergic reactions (rash, swelling, anaphylaxis)
Sensitization: Known to cause skin sensitization in some individuals
Carcinogenicity: Not listed as carcinogenic by NTP, IARC, or OSHA
Mutagenicity: Test data show no evidence of mutagenicity in standard assays
Reproductive Effects: Some animal studies suggest potential effects on fetus at high doses; no confirmed risk in humans at therapeutic doses
Ecotoxicity: Highly toxic to algae and aquatic organisms at low concentrations; may disrupt microbial activity in soil and water
Persistence and Degradability: Not readily biodegradable; relatively stable in aquatic and terrestrial environments
Bioaccumulation Potential: Low bioaccumulation predicted, but it can persist
Mobility: Leaches slowly in soil due to moderate solubility
Other Adverse Effects: May contribute to antibiotic resistance in environmental bacteria
Waste Disposal Methods: Collect and dispose as hazardous chemical waste; incinerate according to local regulations or deliver to approved hazardous waste facility
Contaminated Packaging: Dispose of as unused product; triple rinse and puncture before disposal
Special Precautions: Do not dispose of in household garbage or municipal wastewater; avoid release to environment
UN Number: Not classified as hazardous for transportation by ADR, IMDG, or IATA
UN Proper Shipping Name: Not required
Transport Hazard Class: None
Packing Group: Not assigned
Environmental Hazards: Not regulated for marine pollutant, though care should be taken to prevent release
Transport Precautions: Prevent damage to containers, keep dry, avoid extremes of temperature
US Regulations: Not listed under SARA Title III or CERCLA; prescription drug under FDA regulation
EU Regulations: Not classified as hazardous under 1272/2008/EC (CLP); prescription-only medicine
Other International Regulations: Australia (AICS): Listed; Canada (DSL/NDSL): Listed; Japan (ENCS): Listed
Workplace Labelling: Use appropriate hazard symbols and risk phrases on containers used in workplace settings
Chemical Safety Assessment: Not required for medicinal products in their finished form; risk managed in pharmaceutical manufacturing by standard practices
