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Product Name: Besifloxacin Hydrochloride
Chemical Formula: C19H21ClFN3O3·HCl
CAS Number: 405165-61-9
Intended Use: Active ingredient in ophthalmic preparations for bacterial conjunctivitis treatment
Manufacturer/Supplier: Pharmaceutical companies manufacturing sterile antibiotic solutions
Contact Information: Available through manufacturer’s quality assurance department
Classification: Not classified as hazardous according to GHS criteria, but caution advised due to pharmaceutical activity
Physical Hazards: No significant physical hazard in normal pharmaceutical handling
Health Hazards: May cause eye and skin irritation, respiratory tract irritation after significant exposure; allergic reactions are possible in sensitized individuals
Environmental Hazards: May trigger negative effects in aquatic systems with prolonged exposure
Warning Statements: Avoid inhalation, ingestion, and unnecessary skin contact; avoid environmental release
Main Ingredient: Besifloxacin Hydrochloride (purity >98%)
Impurities: Process-related impurities below threshold limits as per ICH guidelines
Excipients: Not applicable for raw material; refer to finished product formulation for additional ingredients
Eye Contact: Immediately rinse eyes with plenty of water for several minutes, seek medical attention if irritation develops
Skin Contact: Remove contaminated clothing, wash affected area with soap and water, seek medical help for persistent effects
Inhalation: Move the exposed person to fresh air, provide medical support if symptoms such as coughing or difficulty breathing occur
Ingestion: Rinse mouth, do not induce vomiting, obtain immediate medical help
Advice to Physician: Symptomatic support with attention to allergic reactions or respiratory distress; product has anti-infective properties and may disrupt normal flora if absorbed in significant quantities
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, foam
Unsuitable Extinguishing Media: Direct water jet
Special Protective Equipment: Self-contained breathing apparatus and full protective gear to prevent inhalation of decomposition products
Hazardous Decomposition: Risk for toxic vapors such as hydrogen chloride, nitrogen oxides, and halogenated compounds during combustion
Fire and Explosion Hazard: Low fire or explosion hazard, but dust may form explosive mixture with air
Personal Precautions: Wear gloves, safety goggles, dust mask; ensure adequate ventilation
Environmental Precautions: Prevent spill from entering drains, surface water, and soils
Containment and Cleaning: Sweep or vacuum up without producing airborne dust; moisten spill material to avoid dust generation; place in suitable labeled waste container; wash contaminated surfaces thoroughly after cleanup
Handling: Use in well-ventilated areas, practice good industrial hygiene; avoid ingestion, inhalation, and direct skin or eye contact
Storage Conditions: Store in tightly closed containers, protected from moisture, light, and incompatible substances; maintain temperature recommended by manufacturer, typically 2–8°C
Incompatibilities: Strong oxidizers, strong bases or acids may trigger degradation
Engineering Controls: Use laboratory hood or pharmaceutical isolators to avoid airborne exposure
Respiratory Protection: NIOSH-approved dust mask or respirator in scenarios involving generation of powder or aerosols
Eye Protection: Chemical safety goggles
Hand Protection: Nitrile gloves or equivalent
Skin Protection: Protective lab coat or gown
Exposure Limits: Occupational exposure limit not established; minimize exposure based on best practices for pharmaceutical compounds
Hygiene Measures: Wash hands and face thoroughly after handling; remove contaminated clothing before entering break rooms
Appearance: White to off-white crystalline powder
Odor: Odorless
pH: 3 to 5 (1% aqueous solution)
Melting Point: Approximately 250°C (decomposes)
Solubility: Freely soluble in water; slightly soluble in organic solvents
Molecular Weight: 442.85 g/mol (as hydrochloride)
Boiling Point: Not applicable; decomposes before boiling
Vapor Pressure: Negligible at room temperature
Partition Coefficient: LogP ~ 0.75 (calculated)
Flash Point: Not available; nonvolatile solid
Stability: Stable under recommended storage conditions
Decomposition: Decomposes on exposure to heat, strong acids, or bases; releases toxic gases including hydrogen chloride and nitrogen oxides
Reactivity: Avoid contact with strong oxidizing agents, acids, and bases
Polymerization: Does not occur under normal conditions
Acute Toxicity: Oral LD50 in rodents >2000 mg/kg (data from animal studies)
Irritation: May cause skin and eye irritation based on structural similarity to other fluoroquinolones
Allergic Reactions: Possible in those previously sensitized to fluoroquinolones
Chronic Effects: No evidence of genotoxicity or carcinogenicity in studied species; repeated high exposures could cause organ effects (primarily GI tract)
Other Information: Possesses antibiotic activity; potential for disruption of normal bacterial flora on accidental exposure
Ecotoxicity: Expected to be moderately toxic to aquatic organisms; antibiotics may cause long-term adverse effects by promoting antibiotic resistance
Persistence and Degradability: Persists in the environment; slowly degradable under standard conditions
Bioaccumulation Potential: Low, based on molecular properties
Mobility in Soil: Likely to remain in soil matrix; may reach water systems through improper disposal
Waste Treatment: Incinerate under controlled conditions as per local pharmaceutical waste handling laws; approved hazardous waste facilities recommended
Packaging Disposal: Treat contaminated containers as hazardous waste; triple rinse and render unusable before disposal
Environmental Precautions: Do not dispose of in sewage, public water, or general landfill; minimize environmental release to reduce resistance risk
UN Number: Not regulated for transport under ADR, IMDG, or IATA
Proper Shipping Name: Not applicable
Hazard Class: Non-hazardous for transport
Packing Group: Not assigned
Special Precautions for User: Protect container from damage and moisture during transport
Emergency Response: Normal chemical spill procedures apply; report large loss to authorities
TSCA Status: Not listed (pharmaceutical substances typically excluded)
US Federal Regulations: Subject to FDA regulation as a prescription drug;
EU Regulations: Classified as prescription-only medicine; covered by REACH exemption for medicinal products
Other Global Regulations: National chemical inventories may exempt active pharmaceutical ingredients; compliance with drug control and occupational safety rules required
Labeling: Not classified as hazardous, though safety labeling should reference potential risks to users and handlers
