Product Name: Fluticasone Propionate
Chemical Formula: C25H31F3O5S
Synonyms: 6α,9-Difluoro-17β-[(fluoromethyl)thio]11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-propionate
CAS Number: 80474-14-2
Recommended Use: Active pharmaceutical ingredient in inhalers, topical corticosteroids, and nasal sprays for anti-inflammatory effects
Supplier Information: Contact details for purchasing or emergency reference
Emergency Contact: Available through Poison Control Center or supplier hotline
Hazard Classification: Not considered a hazardous substance based on regulatory standards for the prepared dosage forms, but may cause health effects at high exposures to pure API
GHS Classification: Eye irritation (Category 2A), Respiratory sensitizer (Category 1), Specific target organ toxicity (single exposure, Category 3), based on dust inhalation risk
Label Elements: May include exclamation mark, health hazard, and appropriate hazard statements
Health Effects: Prolonged or repeated exposure to dust can cause eye, skin, and respiratory tract irritation; overdose can affect adrenal function and immune response
Environmental Impact: No significant hazard identified in laboratory concentrations but has potential risk to aquatic habitats if released in large quantities
Other Hazards: May be harmful if swallowed, causes local irritation, avoid direct contact and unnecessary environmental release
Main Component: Fluticasone Propionate (purity >99%)
Chemical Family: Synthetic corticosteroid
Impurities: Trace synthetic byproducts from production, less than 1%. Not expected to contribute significant additional hazard.
Stabilizers/Solvents: None in pure API; formulated products often contain excipients like lactose, sorbitan trioleate, and microcrystalline cellulose
Inhalation: Move the affected person to fresh air, seek medical attention if symptoms persist or respiratory irritation occurs; monitor for difficulty breathing
Skin Contact: Wash with plenty of water and mild soap; seek medical attention if rash or irritation persists
Eye Contact: Rinse thoroughly with water for several minutes, remove contact lenses if possible; obtain medical advice if redness or discomfort continues
Ingestion: Rinse mouth with water and consult a physician for possible adverse effects — do not induce vomiting unless instructed by medical personnel
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, or foam
Specific Hazards: Combustion may produce toxic vapors containing carbon oxides, fluorine compounds, and sulfur oxides
Protective Equipment: Firefighters need self-contained breathing apparatus and full protective gear to prevent inhalation of combustion products
Fire Fighting Instructions: Avoid run-off contaminating soil or waterways, contain and collect water used to fight fire for proper disposal; ventilate area after fire is extinguished
Personal Precautions: Wear protective mask, gloves, goggles; avoid creating dust; evacuate non-essential personnel
Environmental Precautions: Prevent further leakage or spillage if safe to do so; avoid discharge into drains, soil, and surface water
Cleanup Methods: Sweep up without raising dust, place in suitable labeled containment for disposal; clean area with damp cloth and wash thoroughly
Disposal: Dispose of according to local guidelines for pharmaceutical products and hazardous chemical waste
Safe Handling: Handle with care to avoid inhalation, ingestion, and skin or eye contact; use in a well-ventilated area or fume hood; implement dust control procedures
Storage Conditions: Store in tightly closed container, away from light, heat, and moisture; preferred temperature ranges between 2°C and 30°C
Incompatibilities: Strong oxidizers, acids, and bases
Other Precautions: Do not store with food, feed, or drinking water, and restrict access to authorized trained personnel
Occupational Exposure Limits: No established threshold limit value; recommended occupational exposure band (OEB) typically in microgram per cubic meter range specific to facility guideline
Engineering Controls: Work in closed systems, use local exhaust ventilation and process enclosures to minimize airborne exposure
Respiratory Protection: Suitable particulate respirator or surgical mask if dust is generated
Hand Protection: Protective chemical-resistant gloves; recommended materials include nitrile or latex
Eye Protection: Chemical safety goggles or face shield
Skin/Body Protection: Laboratory coat or coveralls
Hygiene Measures: Wash hands before eating, drinking, and after handling
Appearance: White to off-white powder
Odor: Odorless or faint medicinal smell
Melting Point: 273-275°C
Solubility: Practically insoluble in water, freely soluble in dimethyl sulfoxide and methanol
Boiling Point: Not applicable (decomposes)
Vapor Pressure: Negligible
Partition Coefficient (logP): 2.0-3.0
Flash Point: Not established
pH: Not applicable (non-aqueous, insoluble in water)
Bulk Density: 0.4-0.6 g/cm³
Stability in Solution: Stable in solid form; solutions degrade under prolonged exposure to light or heat
Chemical Stability: Stable under normal handling and storage conditions
Incompatible Materials: Strong oxidizing agents, strong acids and bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, hydrogen fluoride, sulfur oxides on thermal decomposition
Conditions to Avoid: High humidity, excessive heat, direct sunlight
Polymerization: Will not occur under normal conditions
Acute Toxicity: Estimated oral LD50 in rodents greater than 1000 mg/kg; inhalation at therapeutic doses well tolerated but higher amounts may cause corticosteroid systemic effects
Chronic Exposure: Chronic overexposure may cause effects typical of glucocorticoids, such as skin thinning, immunosuppression, and hypothalamic-pituitary-adrenal axis suppression
Local Effects: Exposure to eyes or mucous membranes leads to irritation; inhalation of high concentrations of dust may cause respiratory discomfort
Sensitization: No reports of sensitization in clinical use; slight risk cannot be excluded for powdered API
Carcinogenicity: Not classified as carcinogenic under IARC or other regulatory agencies; animal studies have not shown clear evidence of carcinogenic potential
Reproductive/Developmental Toxicity: High doses in animal studies may cause fetal toxicity; human risk considered low at therapeutic doses
Mutagenicity: Not found to be genotoxic in standard test systems
Ecotoxicity: No detailed studies in wild settings; lab studies show low aquatic toxicity at environmental concentrations, but persistent contamination over time could affect sensitive aquatic organisms
Persistence and Degradability: Relatively stable under natural conditions; biodegradation and photolysis can slowly break down compound
Bioaccumulation Potential: Expected to be low due to limited water solubility, but low-level buildup possible in sediment
Mobility in Soil: Binds strongly to soil, limiting penetration into groundwater
Other Adverse Effects: Release to waterways should be avoided to prevent ecological imbalance, pharmacologically active compounds may disrupt hormone systems in aquatic life
Waste Treatment Methods: Incinerate in a licensed facility or follow local regulation for pharmaceutical waste
Contaminated Packaging: Dispose of empty containers as hazardous chemical waste after thorough cleaning
Precautions for Disposal: Prevent contamination of surface water, land, or wastewater; follow national and local environmental regulations strictly
Do Not: Discharge into household drains, public sewer, or open environment
UN Number: Not listed under dangerous goods regulations for air, road, or sea transport in most countries
Proper Shipping Name: Fluticasone Propionate (Pharmaceutical chemical, non-hazardous for transport)
Hazard Class: Not assigned
Packing Group: Not assigned
Special Precautions for Transportation: Keep dry, avoid crushing or breakage, protect package from excessive vibration and direct sunlight
Other Information: Transport in accordance with all regulations and guidelines for shipment of APIs or pharmaceuticals
US Federal Regulations: Not specifically listed as hazardous under OSHA or SARA; API status for pharmaceutical production regulated by FDA; storage and handling guided by cGMP
EU Regulations: Not classified as hazardous under CLP; disposal, transport, and use subject to EMA and REACH requirements for active pharmaceutical substances
Label Requirements: Laboratory and workplace labelling must include product name, hazards, and safe handling instructions
Other International Standards: Globally harmonized system (GHS) aligns with above data; healthcare personnel training mandated for workplace safety
Worker Protection: Facilities must have up-to-date training, medical surveillance plans, documentation for all personnel handling the substance
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