Product Name: Spironolactone
Chemical Name: 7α-acetylthio-3-oxo-17α-pregn-4-ene-21,17-carbolactone
Synonyms: Aldactone, Spiractin, Spirotone
CAS Number: 52-01-7
Molecular Formula: C24H32O4S
Molecular Weight: 416.6 g/mol
Recommended Use: Pharmaceutical active substance, diuretic, antihypertensive
Supplier Information: Pharmaceutical companies distributing in US, EU, Asia, with contact details available from each distributor's reference sheet
Emergency Phone Number: Refer to local poison center or manufacturer-specific emergency contact
Classification: Not classified as hazardous according to GHS guidelines, but caution needed for healthcare workers due to hormonal activity
Physical Hazards: Not flammable or explosive in solid form
Health Hazards: May affect endocrine system; long-term exposure may cause hormonal imbalance; possible risk during pregnancy (Category D for pregnancy)
Environmental Hazards: Avoid release to soil and waterways, as chronic exposure to aquatic organisms may disrupt endocrine systems
Label Elements: No mandatory hazard symbol under GHS, but warning statements advised for pregnant women and handlers
Precautionary Statements: Wear protective gear, avoid inhalation or skin contact, follow occupational exposure guidelines
Chemical Name: Spironolactone (active ingredient)
Concentration: 100% (for pure active pharmaceutical ingredient)
Impurities: Trace process impurities ≤0.1% (individual impurity)
Additives: No additives in pure substance; tablet formulations may contain excipients such as lactose, cellulose, magnesium stearate, and starch
Inhalation: Move to area with fresh air, monitor for respiratory symptoms, seek medical attention if discomfort persists
Skin Contact: Remove contaminated clothing, wash area thoroughly with soap and water, medical evaluation recommended if irritation or allergic reaction occurs
Eye Contact: Rinse for several minutes under flowing water, seek medical attention for ongoing irritation
Ingestion: Do not induce vomiting, provide water to dilute, immediate medical attention warranted—especially for children or pregnant individuals
Most Important Symptoms: Nausea, vomiting, drowsiness, dehydration, irregular menstrual cycles
Notes for Medical Personnel: Supportive treatment focused on electrolyte balance; monitor for signs of hyperkalemia and renal impairment
Extinguishing Media: Dry chemical, CO2, or water spray for small fires; foam recommended for large volumes
Special Hazards: Combustion may generate toxic gases including sulfur oxides and carbon oxides
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Fire Fighting Instructions: Avoid inhaling smoke, prevent contaminated run-off from entering watercourses, remove containers from fire area if safe to do so
Personal Precautions: Avoid dust formation, ventilate affected area, limit exposure using PPE including gloves, masks, goggles
Environmental Precautions: Prevent spill migration to soil or waterways, use absorbent material for cleanup
Procedures for Cleanup: Carefully collect spilled material—using vacuum with HEPA units for powders, dispose of clean-up waste according to pharmaceutical hazardous waste regulations, decontaminate tools and surfaces
Safe Handling: Use local ventilation or containment, minimize direct handling, train workers about potential endocrine effects
Storage Conditions: Store in airtight containers, protected from light and humidity, at temperatures below 30°C (86°F) away from incompatible chemicals
Incompatibilities: Oxidizing agents, acids, strong alkalis
Specific Use Considerations: Only trained healthcare professionals or laboratory technicians should handle pharmaceutical active substance in bulk form
Occupational Exposure Limits: No official OSHA or ACGIH value, but internal site-specific occupational exposure banding often used (OEB 3 or equivalent)
Engineering Controls: Use fume hoods, closed systems, or glove boxes where possible
Respiratory Protection: NIOSH-approved respirators when airborne concentrations reach threshold or during clean-up
Eye Protection: Chemical-resistant goggles or face shield
Skin Protection: Nitrile or neoprene gloves, laboratory coats or disposable coveralls
Hygiene Measures: Wash hands after handling, do not eat or drink in work area, remove contaminated clothing and wash before reuse, use lined waste bins for disposal of PPE
Appearance: White or creamy-white crystalline powder
Odor: Odorless
pH: Not applicable (insoluble in water)
Melting Point: 196–198°C (385–388°F)
Boiling Point: Decomposes before boiling
Flash Point: Non-applicable
Solubility: Practically insoluble in water, soluble in alcohol, acetone, chloroform
Vapor Pressure: Not volatile at room temperature
Density: Approximately 1.3 g/cm³
Partition Coefficient (log Kow): 2.04 (estimated)
Stability in Light: Susceptible to degradation on prolonged exposure to strong light, keep protected from direct sunlight
Chemical Stability: Stable under normal laboratory and dispensing conditions
Reactivity: Mildly reactive with strong oxidizing agents, acids, strong bases
Hazardous Reactions: No hazardous polymerization expected
Hazardous Decomposition Products: Sulfur oxides, carbon oxides, other toxic fumes during thermal decomposition
Conditions to Avoid: High humidity, exposure to light, open flames, sources of heat
Acute Toxicity: Oral LD50 (rat): around 1000–2000 mg/kg (variable by study); inhalation and dermal data limited but considered elevated only at significant exposures
Health Effects: Disrupts electrolyte balance, may affect blood pressure, causes endocrine and reproductive effects including menstrual irregularities and feminization symptoms in males
Sensitization: Some evidence of hypersensitivity reactions in susceptible individuals
Carcinogenicity: IARC: Not classified; Long-term high-dose animal studies show increased incidence of certain tumors
Mutagenicity: Negative in standard bacterial mutation assays; weak clastogenicity at very high doses in vitro
Reproductive Toxicity: Embryotoxic and teratogenic at high exposures in animal studies, contraindicated in pregnancy
Specific Target Organ Toxicity: Kidneys, liver, endocrine organs
Environmental Fate: Low solubility, limited biodegradation in aquatic or soil environments, potential for bioaccumulation
Ecotoxicity: Limited direct toxicity in aquatic organisms, but disruption of hormone systems recorded at sublethal concentrations
Mobility in Soil: Places with clay or organic content delay migration, but breakdown products may persist
Persistence and Degradability: Resists rapid environmental degradation, may persist in pharmaceutical manufacturing effluent
Bioaccumulative Potential: Log Kow value indicates moderate risk for buildup in animal tissues over long-term exposure
Other Adverse Effects: Improper disposal or continuous low-level release into the environment may harm aquatic life and disrupt ecosystem balance
Waste Treatment Methods: Collect and manage as hazardous pharmaceutical waste; incinerate at high temperature in an approved facility; chemical neutralization not recommended
Pesticides or Drug Take-Back Program: Contact local authorities to arrange participation in controlled substance return or amnesty events, if available
Contaminated Packaging: Triple-rinse and put in hazardous waste stream, or incinerate with regulatory permission
Special Precautions: Do not discharge into drains, surface waters, or general landfill; avoid release of dust or powder in the environment
UN Number: No UN classification assigned for finished tablets or bulk API
Proper Shipping Name: Spironolactone
Transport Hazard Class: Non-hazardous substance under ADR, IMDG, IATA
Packing Group: Not applicable
Special Precautions for Transport: Ship in sealed, labelled containers; shield from moisture, temperature extremes, and light; follow carrier-specific requirements for pharmaceuticals
Maritime Transport: No special requirements; bulk APIs shipped in compliance with good distribution practices
Regulatory Status: Prescription drug under FDA and EMA; controlled substance status varies by country
Labelling Requirements: Warning statements for pregnant women, endocrine disruption, and workplace exposure for bulk product; safety data sheet must be provided to industrial users
Workplace Exposure Guidance: OSHA Hazard Communication Standard applies; use of PPE mandatory in manufacturing according to U.S. and EU regulations
Other Regulations: Reach Annex II (EU); compliance with Clean Water Act if discharging pharmaceutical residues; state or national environmental protection agency guidelines for hazardous waste disposal; requires record-keeping for all significant releases or incidents
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