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Product Name: Sitafloxacin Monohydrate
CAS Number: 163253-35-8
Molecular Formula: C19H18F2N4O3•H2O
Molecular Weight: 410.39 g/mol
Common Uses: Antibacterial pharmaceutical substance, primarily applied in clinical and laboratory settings for infection management
Manufacturer: Pharmaceutical supplier information printed on product packaging
Emergency Contact: Provided by manufacturer; typically accessible through workplace safety coordinator
Issued Date: Update as printed by supplier
Classification: Eye irritant, skin sensitizer, hazardous if inhaled or ingested
GHS Label Elements: Exclamation mark symbol, hazard warning for respiratory sensitization
Hazard Statements: May cause eye and skin irritation, may provoke allergic reaction upon dermal exposure, hazardous to aquatic environment
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, restrict release into environment
Acute Health Effects: Risk of irritation to mucous membranes, drowsiness, headaches may develop with overexposure
Chronic Health Effects: Long-term contact might cause skin conditions like dermatitis or respiratory sensitization
Chemical Identity: Sitafloxacin Monohydrate
Concentration: 100% active pharmaceutical ingredient
Impurities: Trace synthetic intermediates below pharmacopeia limits
Other Ingredients: No evidenced proprietary blend or excipients present in raw bulk material
Inhalation: Move affected person to fresh air immediately, keep person warm and at rest, seek prompt medical advice if symptoms persist
Skin Contact: Remove contaminated clothing, wash affected skin area thoroughly with water and mild soap, obtain medical attention for persistent irritation
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, continue rinsing and contact medical services if discomfort continues
Ingestion: Rinse mouth with water, do not induce vomiting unless instructed by a physician, consult a healthcare professional without delay if large quantity was swallowed or adverse symptoms develop
Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, foam, water spray
Unsuitable Extinguishing Media: High-pressure water jets can disperse powder and should be avoided
Special Hazards: Combustion may release hazardous fumes such as carbon oxides, nitrogen oxides, and hydrogen fluoride
Protective Equipment: Wear full protective gear, including self-contained breathing apparatus to minimize exposure to toxic combustion products
Firefighting Instructions: Avoid inhalation of dust or smoke, use firefighting methods to prevent runoff entering drains or watercourses
Personal Precautions: Don personal protective equipment like gloves, goggles, and disposable masks before accessing contaminated area
Environmental Precautions: Keep powder away from drains and open water sources, limit spread of material
Cleaning Methods: Sweep up carefully using HEPA filtered vacuum or damp methods to avoid dust generation, transfer residue to appropriate waste container for safe disposal
Decontamination: Clean affected surfaces with suitable detergent and water, avoid use of solvents
Safe Handling Recommendations: Handle in well-ventilated areas, avoid contact with skin, eyes, and clothing, do not ingest or inhale powder, maintain good personal hygiene during use
Storage Conditions: Keep container tightly closed in a dry, cool, and well-ventilated place, store away from incompatible substances such as strong oxidizing agents
Packaging Materials: Use high-integrity containers to prevent leaks and moisture ingress, label container clearly with product identification and hazard warnings
Incompatibilities: Store away from combustible and reducing agents, acids, and bases
Occupational Exposure Limits: Not established specifically for sitafloxacin; follow general pharmaceutical dust exposure guidelines, limit airborne exposure
Engineering Controls: Utilize local exhaust ventilation or process enclosure to reduce dust concentration in working air
Respiratory Protection: Use NIOSH-approved particulate respirator for airborne powder exposure
Eye Protection: Safety goggles or face shield with good lateral coverage
Hand Protection: Chemical-resistant gloves such as nitrile or neoprene
Skin Protection: Laboratory gown, avoid uncovered areas, wash hands after handling
Appearance: White to pale yellow, crystalline powder
Odor: Odorless or slight pharmaceutical
pH: Not available; usually neutral to slightly acidic in aqueous suspension
Melting Point: Decomposes prior to melting; estimated around 230–235°C
Solubility: Soluble in water and many polar solvents
Partition Coefficient (log P): Data not widely published; expected negative value owing to good water solubility
Vapor Pressure: Negligible at room temperature
Boiling Point: Not applicable for solid powder
Flash Point: Not considered flammable under typical handling conditions
Chemical Stability: Stable under recommended storage conditions, transitions quickly to decomposition at excessively high temperatures or upon contact with strong acids
Hazardous Reactions: Risk of formation of toxic gases such as hydrogen fluoride under fire or severe acid treatment
Incompatible Materials: Avoid contact with strong oxidizers, bases, and acids
Hazardous Decomposition Products: Generates carbon monoxide, carbon dioxide, nitrogen oxides, and fluorine-containing compounds during combustion
Acute Toxicity: Data from animal studies shows oral LD50 greater than 2000 mg/kg in rodents, lower risk for acute oral poisoning at occupational doses
Skin Corrosion/Irritation: Risk of mild to moderate irritation following direct contact, longer exposure increases sensitivity possibility
Eye Damage/Irritation: Can cause mild to significant conjunctival irritation
Respiratory Sensitization: Prolonged inhalation could sensitize airways, reports occasionally note lab worker allergies over repeated exposure
Carcinogenicity: No conclusive evidence in standard animal studies
Reproductive Toxicity: Effects described in animal studies at high doses include risk to fetal development, none anticipated for low-level occupational exposure
Mutagenicity: Negative in many standard testing systems
Symptoms of Overexposure: Headaches, lightheadedness, mild dermatitis, respiratory discomfort
Ecotoxicity: Data from related fluoroquinolones indicate that aquatic organisms may suffer acute effects at relatively low concentrations, risk of bioaccumulation in water
Persistence and Degradability: Moderate persistence reported in surface waters; susceptible to breakdown under sunlight and high temperatures
Bioaccumulation: Potentially low due to high water solubility, but chronic effects not excluded
Mobility in Soil: Leachability into soil and groundwater possible, deposit all waste safely away from water courses
Other Adverse Effects: Pharmaceuticals in water can disrupt bacteria and microflora, long-term hazard remains under study
Waste Treatment Methods: Dispose through authorized chemical waste contractor, preferred method incineration under controlled conditions
Container Disposal: Treat used container as hazardous, empty residue completely, triple rinse with water, dispose in accordance with local hazardous waste authority
Special Precautions: Do not allow product to reach sewage system or water bodies, avoid release to the environment whenever possible
UN Number: Not assigned for non-commercial pharmaceuticals in solid form
Transport Hazard Classification: Not regulated as dangerous goods by most transportation modalities
Packing Group: No specific packing group
Proper Shipping Name: Sitafloxacin Monohydrate
Transport Precautions: Pack securely to minimize dust emission, keep away from food and feedstuffs, use secondary containment to prevent spillage during transit
Labeling Requirements: Package must clearly show material identity, hazards, and emergency response phone numbers
US Regulations: Not listed as hazardous by OSHA or SARA Title III; prescription active substance under federal controlled use
EU Regulations: Classified as hazardous for worker safety; tightly regulated active pharmaceutical ingredient under EMA guidelines
International Inventory Status: Registrations required for import, use, disposal in destination countries
Other Regulations: Import/export, transportation, laboratory use, and waste handled according to national and local health and environmental protection legislation, track and document all transfers and disposals
