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Material Safety Data Sheet (MSDS) for Ciprofloxacin Lactate

Identification

Product Name: Ciprofloxacin Lactate
Chemical Family: Fluoroquinolone antibiotic
CAS Number: 86393-32-0
Molecular Formula: C17H18FN3O3 · C3H6O3
Synonyms: Ciprofloxacin lactate salt
Recommended Use: Pharmaceutical ingredient for antimicrobial therapy
Manufacturer Information: Refer to the product labeling for details such as address and emergency phone number
Emergency Contact: National Poison Control Center +1-800-222-1222 or manufacturer’s safety office

Hazard Identification

Classification: Eye irritant (Category 2A), Skin sensitizer (Category 1B)
Signal Word: Warning
Hazard Statements: Causes serious eye irritation, may cause allergic skin reaction, may cause respiratory irritation
Pictograms: Exclamation mark symbol
Health Hazards: Irritates eyes, respiratory tract, skin; risk of allergic reaction; ingestion may cause gastrointestinal symptoms; chronic exposure may damage liver and kidney functions
Precautionary Statements: Avoid breathing dust; wear protective gloves and safety glasses; wash thoroughly after handling; avoid release to environment

Composition / Information on Ingredients

Ciprofloxacin Lactate: 98–100%
Chemical Identity: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(piperazin-1-yl)-quinoline-3-carboxylic acid, lactate salt
Impurities: Less than 2% (typical substances include related fluoroquinolone compounds and unreacted lactate)

First Aid Measures

Inhalation: Move subject to fresh air immediately; seek medical advice if symptoms like shortness of breath or coughing persist
Skin Contact: Remove contaminated clothing; rinse skin with copious amounts of running water and soap; if irritation develops, consult a medical professional
Eye Contact: Rinse eyes cautiously with plenty of water for several minutes; remove contact lenses if present and easy to do; continue rinsing; seek medical attention if irritation persists
Ingestion: Wash out mouth with water if subject is conscious; consult a doctor at once and show product label; never induce vomiting without advising from a medical provider

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, foam, carbon dioxide, or dry chemical as needed for surrounding fire
Specific Hazards: Emits toxic fumes under fire conditions, including carbon oxides, nitrogen oxides, hydrogen fluoride
Protective Equipment: Firefighters should wear full protective gear and self-contained breathing apparatus (SCBA)
Further Advice: Avoid run-off from fire control or dilution water from entering waterways or sewer system

Accidental Release Measures

Personal Precautions: Avoid contact with eyes and skin; do not breathe dust; wear protective clothing, nitrile gloves, safety goggles, and particulate respirator
Environmental Precautions: Prevent contamination of soil, ditches, sewers, and waterways
Methods for Clean-Up: Use non-sparking tools to collect spilled material; sweep up and place in suitable, labeled container for disposal; ventilate affected area

Handling and Storage

Handling: Handle in well-ventilated area; avoid formation of dust; maintain good hygiene practices such as frequent hand washing; avoid eating or drinking near handling area
Storage: Store in tightly closed original container; keep in cool, dry place away from heat and direct sunlight; keep away from incompatible substances like strong oxidizers and reducing agents; store in an area designated for pharmaceuticals

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation to control airborne concentrations below exposure limits
Personal Protection Equipment (PPE): Wear nitrile gloves, safety goggles, laboratory coat, and appropriate respiratory protection in poorly ventilated areas
Occupational Exposure Limits: No established limits for ciprofloxacin lactate; try to keep exposures as low as possible based on minimal available toxicity data
Environmental Controls: Prevent release to surface water, air, or soil

Physical and Chemical Properties

Appearance: Pale yellow to off-white crystalline powder
Odor: Odorless or faint medicinal smell
pH: 4.0–5.5 (1% solution in water)
Melting Point: 250–260°C (decomposition)
Solubility: Freely soluble in water; sparingly soluble in ethanol and methanol
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not flammable under normal conditions
Vapor Pressure: Not determined
Rel. Density: 1.40–1.60 (water = 1)
Partition Coefficient (Log Pow): -0.34 to 0.4

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Exposure to light, moisture, high temperature; formation of dust clouds
Incompatible Materials: Strong oxidizing agents, strong acids or bases
Hazardous Decomposition Products: May produce toxic fumes of nitrogen oxides, carbon monoxide, and hydrogen fluoride during combustion or decomposition
Polymerization: Does not undergo dangerous polymerization

Toxicological Information

Acute Toxicity: Oral LD50 (rat) 5000 mg/kg; signs include diarrhea, nausea, and vomiting
Skin Corrosion/Irritation: May cause mild skin irritation, especially upon prolonged contact
Eye Damage/Irritation: Causes moderate to severe eye irritation
Respiratory and Skin Sensitization: May trigger allergic skin reactions; inhalation of dust may irritate respiratory tract
Chronic Toxicity: May cause effects on liver and kidneys with long-term exposure; possible central nervous system effects, tendonitis, or gastrointestinal disturbances
Carcinogenicity/Mutagenicity: Not considered carcinogenic by IARC or NTP; mutagenicity not confirmed in animal studies
Reproductive Toxicity: High doses impair fetal growth in animal tests; safety in pregnancy not fully established

Ecological Information

Toxicity to Aquatic Life: Toxic to some aquatic organisms (algae, fish, daphnia) at micropollutant levels
Persistence/Degradability: Moderately persistent in surface water or soil due to halogen presence; may form stable residues
Bioaccumulation Potential: Low to moderate; possible accumulation in fish and plants
Mobility in Soil: Mobile in water; can leach to groundwater under suitable conditions
Other Adverse Effects: Antibiotic resistance development in exposed microorganisms

Disposal Considerations

Methods of Disposal: Dispose material via licenced chemical waste contractor; incineration in accordance with local, regional, and national regulations
Contaminated Packaging: Rinse containers thoroughly and dispose like unused product; do not reuse packaging
Environmental Precautions: Do not allow material or water containing this product to enter drains, waterways, or soil

Transport Information

UN Number: Not regulated as dangerous under UN transport rules
Proper Shipping Name: Ciprofloxacin lactate
Hazard Class: Non-hazardous for transport
Packing Group: Not applicable
Marine Pollutant: Not classified as marine pollutant
Transport Labels: No special markings required on transit

Regulatory Information

TSCA Status: Not listed on US TSCA inventory due to pharmaceutical use
EU Classification: Not listed as hazardous under REACH or CLP for transport; pharmaceutical legislation applies
OSHA Hazard Communication Standard: Considered hazardous chemical due to toxicity; subject to labeling, training, and handling controls as set by federal and state law
WHMIS (Canada): Not regulated under Controlled Products Regulations
Other Regulations: Complies with ICH pharmaceutical standards; check local country requirements for workplace and environmental release controls