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Product Name: Prulifloxacin
Chemical Name: 6-Fluoro-1-(2-oxo-1,2-dihydro-1,7-naphthyridin-4-yl)-7-(4-methyl-1-piperazinyl)-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid ethyl ester
Synonyms: Prulifloxacin, Pruliflox
Recommended Use: Pharmaceutical intermediate, antibacterial agent
CAS Number: 123447-62-1
Manufacturer Information: Supplied by pharmaceutical manufacturers; emergency contacts available through regional poison control centers.
Hazard Class: Not classified under GHS for physical or health hazards at the end-user level; dust generation may irritate airways.
Risk Phrases: Possible risks of eye, skin, or respiratory tract irritation on extended exposure.
Precautionary Statements: Avoid breathing dust or powder; prevent contact with eyes and skin.
Mental/Physical Health Effects: Reports indicate nausea, headache, and possible CNS effects in overdose scenarios; occupational effects rare but possible when handling bulk powder.
Component: Prulifloxacin, pure active pharmaceutical ingredient
Chemical Formula: C18H19FN4O4
Concentration: 98%+
Impurities: Trace synthesis and degradation byproducts, typically <2% by weight
Ingredient Hazard: No major byproducts present at levels needing special disclosure under standard hazard communications.
Inhalation: Move affected person to fresh air, maintain an open airway, seek medical assistance if irritation or symptoms persist.
Skin Contact: Remove any contaminated clothing, wash skin thoroughly with water and mild soap.
Eye Contact: Rinse immediately with gentle water stream for several minutes, lift eyelids, seek prompt medical attention for persistent irritation.
Ingestion: Rinse mouth thoroughly, seek medical evaluation even for minor symptoms, avoid inducing vomiting unless instructed by professionals.
Advice to Physician: Symptomatic treatment—no specific antidote; monitor vital signs in case of accidental ingestion or observed overdose.
Suitable Extinguishing Media: CO2, dry chemical, alcohol-resistant foam, or water spray for large fires.
Hazards from Combustion Products: Potential release of toxic fumes such as carbon oxides, nitrogen oxides, and fluorine compounds; avoid inhaling combustion products.
Protective Equipment for Firefighters: Use self-contained breathing apparatus (SCBA) and full protective gear to guard against exposure.
Special Procedures: Cool unaffected containers with water; prevent run-off from entering water sources.
Personal Precautions: Wear gloves, safety goggles, dust mask or respirator; ventilate area.
Environmental Precautions: Prevent entry into waterways, drains, or soil to minimize environmental spread.
Spill Cleanup Methods: Scoop spilled material with minimum dusting, place dust in container for proper disposal; wash residue from spill area with water.
Containment: Use absorbent materials if necessary to reduce spread, seal in labeled containers for waste disposal.
Handling: Work with product in well-ventilated zones, minimize airborne dust generation, wash after handling, do not eat/drink/smoke in work area, close containers tightly.
Storage Requirements: Store in original container, keep tightly sealed, keep in a dry, cool place, avoid direct sunlight, segregate from incompatible chemicals and reducing agents.
Storage Temperature: Controlled room temperature preferred, typically 15–25°C; refrigerate only if directed by supplier or stability data.
Occupational Exposure Limits: No official workplace limits for Prulifloxacin exist; recommended good industrial hygiene practices.
Engineering Controls: Local exhaust or general ventilation to maintain dust concentrations below nuisance levels.
Personal Protective Equipment: Nitrile or latex gloves, chemical safety goggles, suitable protective clothing, dust mask or particle respirator (N95 or higher).
Hygiene: Wash hands after use, remove contaminated clothing, avoid touching face, eyes, or exposed skin during handling.
Appearance: White to pale yellow crystalline powder
Odor: Odorless or faint chemical odor
Melting Point: Approximately 200-220°C (decomposition observed at higher temperatures)
Boiling Point: Not relevant due to decomposition prior to boiling
Solubility: Slightly soluble in water; soluble in organic solvents such as DMSO and methanol
pH: Neutral to slightly acidic in water
Vapor Pressure: Negligible at ambient conditions
Density: ~1.5 g/cm3
Chemical Stability: Stable under recommended conditions, but degrades with prolonged exposure to high heat, light, or moisture.
Reactivity: Non-reactive with most typical laboratory or industrial reagents.
Conditions to Avoid: Strong oxidizing agents, high temperatures, prolonged light exposure, and humid environments.
Decomposition Products: May form toxic gases such as carbon monoxide, CO2, nitrogen oxides, and potentially HF under intense heat.
Acute Toxicity: Oral LD50 (rat) >2000 mg/kg; low acute toxicity by contact or inhalation at typical exposure levels.
Chronic Toxicity: Animal studies show changes in liver and kidney at high repeated doses; possible musculoskeletal effects such as tendinitis or tendon rupture, as class-associated risk with fluoroquinolones.
Sensitization: Rare allergic skin reactions reported in susceptible individuals; monitor for rashes or other hypersensitivity.
Mutagenic/Carcinogenic Effects: Not classified as carcinogenic based on existing data; not considered mutagenic at relevant exposure.
Specific Organ Toxicity: Watch for CNS effects, gastrointestinal disturbances, phototoxicity with high exposures.
Medical Conditions Aggravated by Exposure: Individuals with history of tendon disorders, epilepsy, or hypersensitivity to quinolones should exercise extra caution.
Aquatic Toxicity: Adverse impact on aquatic species has been seen in studies; low concentrations may inhibit algae and invertebrate function.
Soil Mobility: Moderate soil binding, potential to leach into waterways if not contained.
Persistence and Degradability: Degrades slowly in environment; risk of bioaccumulation in aquatic food chains.
Other Adverse Effects: Can disrupt wastewater treatment bacteria, avoid uncontrolled releases to sewage.
Disposal Methods: Dispose of product and contaminated materials in accordance with official regulations on hazardous pharmaceutical waste.
Incineration: Incinerate in certified facility equipped to manage fluorinated pharmaceuticals; avoid landfill disposal unless permitted by specific local rules.
Unused Product: Return to supplier or submit to authorized hazardous waste handler.
Container Disposal: Clean containers, render unusable, and dispose as hazardous waste.
Environmental Precautions: Prevent product from reaching natural water sources, inform authorities if spills lead to environmental contamination.
UN Number: Not regulated as dangerous goods for air, road, or rail transport under typical labeling.
Transport Hazard Class: No specific class indicated; not regarded as hazardous under standard ADR, RID, IATA, IMDG conventions.
Packing Group: No classification required for non-bulk pharmaceutical powders.
Special Transport Precautions: Secure containers upright, shield from direct sunlight and moisture during transport, report incidents of significant leakage or improper labeling to authorities.
Labeling Requirements: Product labeling should reflect pharmaceutical regulations of the country of sale; occupational labels for irritant dust exposure where appropriate.
TSCA Status: Prulifloxacin not subject to routine chemical industrial tracking, classified for pharmaceutical/clinical use.
REACH/CLP: Exempt from REACH registration as a medicinal product but subject to local workplace safety regulations.
OSHA/GHS Compliance: Managed as low-hazard laboratory chemical; refer to workplace chemical hygiene plans including exposure controls and spill response.
Other Regulations: State/province requirements may differ—regularly review updated guidance for handling antimicrobial actives and hazardous waste pharmaceuticals.
