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Product Name: Gatifloxacin
Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid
Synonyms: Gatifloxacin anhydrous, Tequin
CAS Number: 112811-59-3
Recommended Use: Pharmaceutical active ingredient (antibiotic)
Manufacturer Information: Details provided on request due to regulatory and proprietary status.
Classification: Harmful if swallowed, irritating to eyes and respiratory tract, possible teratogen based on animal data, considered hazardous under OSHA Hazard Communication Standard
Signal Word: Warning
Hazard Statements: May cause eye and respiratory irritation; Harmful if ingested; May affect unborn child
Precautionary Statements: Avoid inhaling dust; do not get in eyes, on skin, or on clothing; use only outdoors or in well-ventilated area
Gatifloxacin: ≥98% purity (active component)
Impurities: Residual solvents and trace intermediates may be present (<1%) dependent on manufacturing quality;
Excipients or Dilutants: None in raw material format
Inhalation: Move to fresh air immediately; support breathing if symptoms appear; seek medical attention for persistent irritation or difficulty
Skin Contact: Remove contaminated clothing; wash skin thoroughly with soap and water; obtain medical advice for persistent irritation
Eye Contact: Rinse eyes gently with water for at least 15 minutes; avoid rubbing; seek prompt ophthalmological care
Ingestion: Rinse mouth thoroughly; do not induce vomiting unless directed by medical personnel; monitor for symptoms like nausea or dizziness; seek medical attention
Suitable Extinguishing Media: Dry chemical, foam, or carbon dioxide; do not use water jet
Specific Fire Hazards: May produce toxic fumes of carbon oxides, nitrogen oxides and hydrogen fluoride in a fire
Advice for Firefighters: Wear self-contained breathing apparatus; use standard protective gear to prevent inhalation and skin/eye exposure; fight fire from a safe distance
Spill Containment: Evacuate area, provide adequate ventilation, and prevent airborne dust formation
Clean-up Methods: Use non-sparking tools and sweep up material; dampen to avoid dust; collect in appropriate container for disposal
Personal Protective Equipment: Gloves, goggles, NIOSH-approved respirator as warranted by exposure level, laboratory coat
Environmental Precautions: Prevent release into drains, waterways, and soil; report releases to proper authorities
Handling Conditions: Use with adequate ventilation; avoid contact with eyes, skin, and clothing; employ dust control measures and exhaust; handle in accordance with industrial hygiene protocols
Storage Requirements: Store in tightly closed container; keep dry; avoid extremes of heat, cold, and direct sunlight; segregate from incompatible chemicals such as strong oxidizers and acids
Incompatibilities: Strong oxidizing agents, strong acids, elevated temperatures
Exposure Limits: No ACGIH, OSHA, or NIOSH exposure limits established for active pharmaceutical ingredient; minimize exposure per workplace best practice
Engineering Controls: Local exhaust ventilation, testing for airborne dust, properly functioning fume hood recommended for lab scale
Personal Protective Equipment: Chemical-resistant gloves (e.g. nitrile), safety glasses or chemical splash goggles, lab coat or chemical-resistant apron, NIOSH-approved particulate respirator in presence of fine dust or powder clouds
General Hygiene: Wash hands before breaks and after handling; do not eat, drink, or smoke in laboratory or production area; use dedicated clothing
Appearance: White to pale yellow crystalline powder
Odor: Odorless or faint odor
Boiling Point: Decomposes before boiling
Melting Point: Approximately 180-184°C
Solubility: Slightly soluble in water, freely soluble in dilute acid solutions, sparingly soluble in organic solvents like methanol
Molecular Weight: 375.4 g/mol
pH (1% solution, 25°C): ~7.0-8.0
Partition Coefficient (logP): -0.23
Vapor Pressure: Not available (negligible at room temperature)
Chemical Stability: Stable under recommended handling and storage conditions; hydrolyzes slowly in acidic or basic environments
Reactivity: No dangerous reactions under normal conditions; avoid contact with highly reactive chemicals
Decomposition Products: Burning can release toxic gases such as CO, CO2, nitrogen oxides, hydrogen fluoride
Polymerization: Will not occur under normal handling
Acute Toxicity: Animal studies (oral, rat) LD50 ~2000 mg/kg; inhalation and dermal data limited
Skin/Eye Effects: Mild to moderate irritant in rabbits and guinea pigs; avoid direct contact
Sensitization: Potential for skin sensitization not excluded with prolonged contact
Chronic Exposure: Animal data shows lens and joint toxicity at high doses; risk of tendon damage with prolonged clinical use
Carcinogenicity/Mutagenicity: No evidence for human carcinogenicity; did not induce mutation in standard tests
Reproductive/Developmental Toxicity: Negative in animal teratogenicity studies at therapeutic doses; high doses crossed placental barrier and caused developmental delays
Ecotoxicity: Highly toxic to aquatic organisms; chronic aquatic toxicity expected based on persistence and bioaccumulation studies
Persistence/Degradability: Not readily biodegradable; may persist in water and soils
Bioaccumulation: Low to moderate potential (logP -0.23); accumulation in higher trophic levels not ruled out
Mobility in Soil: Moderate mobility; leaching possible in sandy soils; binds to organic matter
Environmental Precautions: Avoid any environmental release, especially into waterways, agricultural soils, or wastewater
Waste Disposal: Dispose of by controlled incineration or in accordance with official regulations for hazardous pharmaceutical ingredients
Contaminated Packaging: Dispose of as hazardous waste; decontaminate before recycling where feasible
Disposal Precautions: Do not discharge to sewer systems or municipal drainage; follow all regional and national regulations for antibiotics/waste medicines
UN Number: Not classified as hazardous for transport under current UN criteria
Proper Shipping Name: Not regulated as a dangerous good
Transport Hazard Class: Not assigned; avoid extreme temperatures and direct sunlight during transit
Packing Group: Not applicable
Special Precautions: Protect from moisture, store in securely closed primary packaging; clearly label all units
Relevant Transport Regulations: Follow pharmaceutical transit protocols and any applicable country-specific guidelines
OSHA: Considered hazardous as per OSHA Hazard Communication Standard
TSCA Status: Not listed
IATA/IMDG: Not classified as hazardous for air/sea transport
WHMIS (Canada): Not controlled
Inventory Listings: Complies with EU REACH for research use; US DEA schedule: not controlled
Other Regulations: Subject to pharmaceutical regulations for manufacture, distribution, and quality control; follow all local, national, and international standards for pharmaceuticals and environmental safety
