Product Name: Fludrocortisone Acetate
Synonyms: 9α-Fluoro-11β,21-dihydroxy-3,20-dioxopregn-4-en-17-yl acetate
CAS Number: 514-36-3
Recommended Use: Pharmaceutical grade corticosteroid
Supplier Details: Sourced through regulated pharmaceutical supply channels, with manufacturing conducted under GMP compliance
Contact Information: Emergency contacts provided through local poison control centers and pharmaceutical distribution chains
Classification: Not classed as hazardous under GHS for general population, but may produce toxic effects in overexposure
Main Hazards: Possible respiratory irritation, skin or eye irritation in case of contact; may alter electrolyte balance if ingested
Warning Symbols: Exclamation mark (irritant), Health hazard (systemic toxicity, if misused)
Precautionary Statements: Avoid direct inhalation, skin contact, or ingestion; keep away from children and unauthorized personnel
Chemical Identity: Fludrocortisone Acetate
PURITY: >98% (pharmaceutical standard)
Excipient Content: Trace amounts of stabilizers depending on formulation
Molecular Formula: C23H31FO6
Molecular Weight: 450.49 g/mol
Eye Contact: Irrigate immediately with copious amounts of water for at least 15 minutes, seek medical attention for persistent discomfort
Skin Contact: Remove contaminated clothing, rinse skin with soap and water; consult a doctor if irritation develops
Inhalation: Move exposed person to fresh air, monitor for respiratory distress, provide oxygen and medical support as required
Ingestion: Rinse mouth with water, do not induce vomiting; seek immediate medical support
Note to Physician: Treat based on symptoms and provide supportive care, monitor for electrolyte imbalances and hypertension
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray
Specific Hazards: Material can decompose to emit toxic fumes, including carbon monoxide, carbon dioxide, hydrogen fluoride, and other irritants
Special Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Additional Information: Avoid inhaling dust, smoke, or combustion products; prevent runoff into drains and water courses
Personal Precautions: Wear nitrile gloves, protective lab coat, safety goggles, and respirator if powder is airborne
Environmental Precautions: Prevent spillage into soil, waterways, or public drainage and restrict access to spill area
Methods for Cleanup: Vacuum up powder using HEPA-filtered equipment or dampen powder before sweeping up into a chemical waste container
Decontamination: Wash spill area thoroughly with soap and water after bulk material removal
Disposal Method: Dispose of all cleanup materials as hazardous pharmaceutical waste in accordance with local and national regulations
Handling Instructions: Use inside fume hoods or well-ventilated areas, avoid producing dust, never eat, drink, or smoke in handling areas
Personal Hygiene: Practice regular hand washing and avoid touching face or exposed skin areas prior to cleanup
Storage Conditions: Store in tightly sealed containers at 2–8°C, away from incompatible substances (strong oxidizers, acids)
Incompatibilities: Avoid exposure to moisture, high temperatures, and direct sunlight
Security Measures: Limit access to authorized, trained personnel; ensure containers are clearly labeled
Exposure Limits: No established occupational exposure limit, use workplace best practices as for potent corticosteroids
Engineering Controls: Utilize local exhaust ventilation, fume hoods, and biological safety cabinets during handling
Personal Protective Equipment (PPE): Gloves (nitrile preferred), laboratory coats, safety glasses with side shields, and certified respirators if airborne dust risk present
General Hygiene: Prohibit food and drink in work zones and ensure prompt removal of contaminated protective equipment
Appearance: White to off-white crystalline powder
Odor: Odorless
pH (aqueous solution): Not applicable or unavailable due to low aqueous solubility
Melting Point: 261–269°C
Solubility: Practically insoluble in water, soluble in alcohol and organic solvents
Vapor Pressure: Negligible at room temperature
Stability: Chemically stable if stored as recommended, sensitive to hydrolysis under acidic or basic environments
Chemical Stability: Remains stable under normal handling and storage conditions
Potentially Hazardous Reactions: Contact with strong oxidizing agents may result in hazardous decomposition
Conditions to Avoid: High temperatures, prolonged exposure to open air, incompatible chemicals
Decomposition Products: Carbon monoxide, carbon dioxide, hydrogen fluoride, and other hazardous fumes in the event of fire or high-temperature decomposition
Routes of Exposure: Inhalation, skin and eye contact, accidental ingestion
Acute Effects: Causes irritation to eyes, mucous membranes, possible skin sensitization; high-dose accidental ingestion may result in increased blood pressure, fluid retention, hypokalemia, or cortical suppression
Chronic Effects: Prolonged occupational exposure may lead to endocrine disruptions and corticosteroid-related metabolic changes
Carcinogenicity: Not classifiable as to carcinogenicity to humans (IARC, NTP, OSHA have not provided classification)
Mutagenicity: No confirmed mutagenic effect from available data
Reproductive Toxicity: Data insufficient, but steroid hormones may affect fetal development if significant exposure occurs during pregnancy
Environmental Fate: Poorly soluble in water, unlikely to biodegrade rapidly
Aquatic Toxicity: Not acutely toxic in the environment but persistence may disrupt hormonal balances in aquatic organisms
Mobility in Soil: Tends to adsorb to soil particles, remains in upper soil layers
Bioaccumulation: Potential for bioaccumulation in fish and aquatic organisms
Additional Considerations: Spilled material poses risk to sensitive environments due to endocrine-disrupting potential
Product Disposal: Place expired or waste Fludrocortisone Acetate in designated hazardous waste containers, utilize authorized waste disposal contractors
Container Disposal: Decontaminate and dispose of containers as per institutional chemical waste protocols
Regulatory Compliance: Follow federal, regional, and local requirements for pharmaceutical and hazardous waste
Avoid: Do not discharge untreated material into sewage systems or natural environments
UN Number: Not classified as a dangerous good for transport under ADR, IATA, IMDG
Proper Shipping Name: Fludrocortisone Acetate
Transport Hazard Class: Non-hazardous for land, air, or sea shipment under normal pharmaceutical transport conditions
Packaging Requirements: Ship in sealed, labeled, leak-proof containers, cushion against physical damage; maintain cold chain if possible
Special Precautions: Notify handlers of material type, maintain documentation and emergency contact details with shipment
FDA / EMA Approval: Approved active pharmaceutical ingredient for designated medical uses
Occupational Health Standards: No OSHA PEL or ACGIH TLV established; handle using best industry safety practices
Environmental Regulations: Comply with regional hazardous waste laws regarding endocrine-disrupting substances
Labeling Requirements: Clearly mark storage and transport vessels with hazard information, batch number, and expiry date
Other Compliance: Adhere to REACH, WHMIS, and other relevant chemical and pharmaceutical handling statutes worldwide where applicable
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