Product Name: Ciprofloxacin Lactate
Chemical Formula: C17H18FN3O3·C3H6O3
CAS Number: 85721-33-1 (for Ciprofloxacin) / 50-21-5 (for Lactic Acid)
Synonyms: Ciprofloxacin Monolactate, Ciprofloxacin Hemilactate
Recommended Use: Active pharmaceutical ingredient, antimicrobial agent
Manufacturer: Pharmaceutical company or supplier information on container label
Contact Information: Emergency contact details provided on shipping documents
Emergency Phone: Refer to supplier or Chemtrec (in case of accident or spill)
GHS Classification: Harmful if swallowed (Acute Toxicity—Oral, Category 4), Eye irritation (Category 2A), May cause respiratory irritation
Pictograms: Exclamation mark for toxicity/irritation
Signal Word: Warning
Hazard Statements: Harmful if swallowed. Causes serious eye irritation. Causes skin irritation. May cause respiratory tract irritation.
Precautionary Statements: Avoid breathing dust. Wash hands thoroughly after handling. Wear protective gloves, protective clothing, and eye/face protection. If in eyes: Rinse carefully with water for several minutes.
Main Ingredient: Ciprofloxacin Lactate
Concentration: 97–100%
Molecular Weight: 385.4 g/mol (approx. for lactate salt)
Related Impurities: Trace residual solvents, related substances from synthesis
Impurity Limits: Keep within pharmacopoeial limits for safe pharmaceutical use
Inhalation: Remove person from exposure to fresh air. Seek medical advice if breathing becomes difficult or symptoms occur.
Skin Contact: Wash areas of contact with soap and plenty of water. Remove contaminated clothing.
Eye Contact: Flush eyes thoroughly for at least 15 minutes with plenty of water, lifting upper and lower eyelids. Get medical attention if irritation persists.
Ingestion: Rinse mouth with water. Get medical attention promptly. Do not induce vomiting unless directed by medical personnel.
Note to Physician: Treat symptomatically, monitor for signs of allergic reaction or toxic effects such as nausea, diarrhea, or respiratory distress.
Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide. Use what is suitable for surrounding fire.
Special Hazards: May produce toxic fumes of fluorine, nitrogen oxides, carbon monoxide, and carbon dioxide when burned.
Protective Equipment: Firefighters should wear full protective clothing and self-contained breathing apparatus.
Advice for Firefighters: Avoid inhaling combustion products. Prevent spread of contaminated water runoff.
Personal Precautions: Use protective clothing, gloves, eye protection, and a dust respirator for large spills.
Environmental Precautions: Prevent entry to drains, sewers, or water bodies. Notify authorities if large amounts contaminate the environment.
Methods for Cleanup: Sweep up solids carefully without creating dust, and place in appropriate waste container. Clean affected surfaces with soap and water. Ventilate area.
Decontamination: Dispose of spill residues following regulations for pharmaceutical waste.
Safe Handling: Minimize dust generation. Use in well-ventilated areas or fume hood. Wear recommended PPE.
Storage Conditions: Store tightly sealed in original container in a cool, dry, well-ventilated area away from incompatible substances (strong oxidizers, acids).
Storage Temperature: Typically 2–8°C for bulk drug substance, as specified by manufacturer.
Incompatible Materials: Oxidizing agents, bases, and acids; avoid moisture.
Occupational Exposure Limits: Not established for Ciprofloxacin Lactate. For active ingredient, follow workplace exposure guidelines if available.
Engineering Controls: Handle in closed system with local exhaust. Avoid creating dust.
Personal Protective Equipment (PPE): Wear laboratory coat, nitrile or latex gloves, safety goggles or face shield, and a dust mask or respirator (N95 or higher) when necessary.
Hygiene Measures: Wash hands after handling, remove contaminated clothing, do not eat, drink, or smoke in pharmacy or lab.
Appearance: White to faintly yellowish crystalline powder
Odor: Odorless or slightly sweet
pH (1% Solution): About 3–4
Solubility: Soluble in water, practically insoluble in ether
Melting Point: Approximately 220–240°C (decomposes before melting)
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Not volatile at 20°C
Partition Coefficient: log P (octanol/water): 0.28–0.7
Other Properties: Stable under recommended conditions; not flammable
Chemical Stability: Stable under normal conditions if kept dry and cool.
Reactivity: No hazardous reactions under recommended storage and handling.
Conditions to Avoid: Moisture, high temperatures, light, strong oxidizers.
Decomposition Products: Toxic fumes including carbon monoxide, carbon dioxide, hydrogen fluoride, and nitrogen oxides when heated to decomposition.
Polymerization: Does not occur under normal conditions.
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Oral LD50 (rat): ~5000 mg/kg (ciprofloxacin base)
Skin Irritation: May cause mild skin irritation
Eye Irritation: Strongly irritating to eyes
Inhalation: Dust can irritate mucous membranes and respiratory system
Chronic Effects: Prolonged or repeated exposure may cause allergic sensitization or rare neurological signs such as headache, dizziness
Carcinogenicity: No evidence found in animal studies at normal exposure.
Reproductive Toxicity: Possible risk at high doses; data limited for humans.
Ecotoxicity: Harmful to aquatic organisms, potential to cause long-term effects in the environment
Persistence and Degradability: Persistent in the environment; slow degradation in soil and water
Bioaccumulative Potential: Low to moderate
Mobility in Soil: Moderate; can reach groundwater if not properly handled
Other Adverse Effects: Potential to contribute to antibiotic resistance in bacteria in environments exposed to pharmaceutical runoff
Waste Treatment Methods: Dispose of unused material as hazardous pharmaceutical waste via licensed disposal contractor.
Contaminated Packaging: Rinse containers; treat washings as hazardous waste.
Disposal Regulations: Follow local, regional, and national regulations for medical or chemical waste.
Incineration: Preferred method for large quantities where permitted; avoid release to the environment.
UN Number: Not classified as dangerous goods under ADR, IMDG, or IATA when shipped as pharmaceutical product
Proper Shipping Name: Not regulated, or Ciprofloxacin Compound for Research Purposes
Hazard Class: Not assigned
Packing Group: Not assigned
Special Precautions: Ship in sealed container, avoid exposure to moisture and light, ensure packaging secures against spills or releases
Labelling Requirements: GHS-aligned hazard communication and labelling specified
US TSCA: Not listed for this pharmaceutical use
US FDA: Approved for specific medical uses, subject to prescription control
EU Regulations: REACH exemption for medicinal products; waste, transport, and workplace exposure regulations apply
Workplace Safety: OELs not established; handle using good laboratory practice
Other Information: Compliance with national pharmaceutical safety, environmental and occupational health laws required
