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Material Safety Data Sheet: Ciprofloxacin

Identification

Product Name: Ciprofloxacin
Chemical Name: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
Synonyms: Ciprofloxacin hydrochloride, Cipro
Product Code: Manufacturer-specific
Recommended Use: Antibacterial agent for pharmaceutical manufacturing and laboratory analysis
Supplier: Refer to packaging for local distributor
Emergency Contact: Local emergency services or poison control center
CAS Number: 85721-33-1
UN Number: Not classified as hazardous for transportation under most jurisdictions

Hazard Identification

GHS Classification: Not classified as hazardous according to current GHS criteria
Route of Exposure: Inhalation, ingestion, skin and eye contact
Potential Health Effects: May cause irritation to eyes, skin, respiratory tract; overexposure may affect nervous system, GI tract, musculoskeletal system
Hazard Symbols: None under GHS, but can be considered an irritant under some regional systems
Signal Word: Not required
Precautionary Statements: Avoid breathing dust, avoid contact with skin and eyes, wash hands after handling

Composition / Information on Ingredients

Ciprofloxacin: ≥ 98% by weight
Impurities: Not specifically classified as hazardous under GHS
Formulation Additives: None for pure substance; check finished pharmaceutical label for excipients

First Aid Measures

Inhalation: Move person to fresh air, monitor for respiratory distress; seek medical advice if symptoms persist
Skin Contact: Remove contaminated clothing, flush skin with plenty of water; wash with soap if available
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present
Ingestion: Rinse mouth without inducing vomiting, seek immediate medical attention for large exposures
Important Symptoms: Cough, sneezing, headache, rash, GI discomfort in case of accidental exposure
Medical attention: Symptomatic treatment, supportive care as required

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, water spray, foam, or carbon dioxide
Unsuitable Media: Direct water jet for large fires
Fire Hazards: May emit toxic fumes including nitrogen oxides, hydrogen fluoride, carbon monoxide
Protective Equipment: Firefighters wear full protective gear including self-contained breathing apparatus
Special Procedures: Avoid breathing combustion products, contain runoff from fire control

Accidental Release Measures

Personal Precautions: Wear appropriate PPE including gloves, laboratory coat, eye protection, dust mask
Environmental Precautions: Prevent from entering drains or waterways
Spill Cleanup Methods: Sweep up avoiding dust generation, use damp cloth for residues, place waste in marked containers
Disposal: Dispose of in accordance with local, regional, and national regulations
Decontamination: Clean spill area with water after removal of material

Handling and Storage

Handling: Use only in well ventilated areas, minimize dust generation, wash hands after handling, prevent contact with eyes and skin
Storage Conditions: Store in tightly closed container, protect from light, keep in a cool, dry location, isolate from incompatible substances
Incompatibilities: Strong acids, strong bases, oxidizing agents, reducing agents
Other Precautions: Keep out of reach of unauthorized personnel; label clearly

Exposure Controls and Personal Protection

Occupational Exposure Limits (OELs): No specific value set for ciprofloxacin; use pharmaceutical OEB category guidance
Engineering Controls: Local exhaust ventilation, fume hood, containment for dust
Personal Protective Equipment: Safety glasses with side shields or goggles, chemical resistant gloves (nitrile or neoprene), laboratory coat or disposable coveralls, N95 dust mask or cartridge respirator in case of dust formation
Hygiene Measures: Do not eat, drink, or smoke where material is handled; wash hands thoroughly after handling

Physical and Chemical Properties

Appearance: White to pale yellow crystalline powder
Odor: Odorless
pH: 3.0 – 5.0 (1% solution in water)
Melting Point: 255 – 257°C (decomposes)
Solubility: Slightly soluble in water; more soluble in acidic or basic solutions
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Not measured (negligible at ambient temperatures)
Flash Point: Not applicable
Relative Density: Approximately 1.55 g/cm³
Partition Coefficient (log Pow): –0.57

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Conditions to Avoid: Excess heat, exposure to light, moisture
Materials to Avoid: Strong oxidizers, acids, bases, reducing agents
Hazardous Decomposition Products: Nitrogen oxides, hydrogen fluoride, carbon dioxide, carbon monoxide possible under fire conditions
Polymerization: Will not occur

Toxicological Information

Acute Toxicity: Oral LD50 (rat) above 5000 mg/kg; dermal and inhalation data limited
Routes of Exposure: Ingestion, inhalation, dermal contact, ocular contact
Irritation: May cause mild skin and eye irritation
Sensitization: Rare allergic reactions possible (rash, urticaria, anaphylaxis in predisposed individuals)
Chronic Effects: Repeated or prolonged exposure linked to GI disturbances, CNS effects (headache, dizziness), potential tendon damage
Reproductive Toxicity: Data in animal studies suggest possible developmental effects at high doses; not recommended during pregnancy except where benefits outweigh risks
Carcinogenicity: No significant evidence from animal studies at therapeutic doses
Mutagenicity: Negative or equivocal results in most in vitro and in vivo tests
Target Organs: Gastrointestinal tract, liver, kidneys, CNS, musculoskeletal system

Ecological Information

Aquatic Toxicity: LC50 (Fish, 96h) approximately 85 mg/L; toxic to aquatic organisms at high concentrations
Persistence/Degradability: Moderately persistent in soil and water; degradable over time though some breakdown products may persist
Bioaccumulation: Low potential for bioaccumulation (log Pow: –0.57)
Mobility in Soil: Moderate, but depends on pH and environmental conditions
Ecotoxicological Effects: Potential risk for antibiotic resistance in bacteria in soil and water environments if released in large quantities

Disposal Considerations

Disposal Methods: Incineration at an approved facility where possible; landfill per local regulations if incineration unavailable
Container Disposal: Rinse thoroughly before discarding or send to chemical waste supplier
Special Instructions: Never release into environment or watercourses; avoid mixing with other waste streams
Regulatory Waste Code: Refer to local, national, or regional pharmaceutical waste codes

Transport Information

UN Number: Not regulated as a hazardous material in transport
Proper Shipping Name: Ciprofloxacin, non-hazardous for transport
Transport Hazard Class: Not restricted
Packing Group: Not required
Environmental Hazards: None noted for packaged goods; avoid bulk release
Special Precautions: Protect from excessive heat and moisture, keep packaging intact

Regulatory Information

Regulatory Status: Approved as a prescription-only medication in most countries; not classified as hazardous for transport or typical occupational hazard under GHS
Inventory Listings: Listed on chemical inventories for compliance in North America, Europe, Asia
Workplace Safety: OSHA Laboratory Standard; similar standards in EU and Asia for lab and pharmaceutical settings
Other References: ICH, FDA guidances for handling APIs in pharmaceutical industries; local workplace regulations