Product Name: Eplerenone
Chemical Formula: C24H30O6
Synonyms: Inspra, methyl eplerenone, UNII-CRN4T60L99
CAS Number: 107724-20-9
Recommended Use: Active pharmaceutical ingredient in treatment of hypertension and heart failure
Manufacturer Details: Full company address, emergency contact phone number, email for MSDS requests
Relevant Identified Uses: For manufacture of pharmaceutical products and research
Restrictions: Not for personal or household application outside regulated environments
Classification: Not classified as hazardous under GHS guidelines for finished pharmaceutical form, but caution advised with bulk powder
Physical Hazard: Fine particulate may cause dust explosion in enclosed space
Health Hazard: Potential to cause respiratory tract irritation, skin and eye irritation, rarely headache, nausea, vomiting upon significant exposure
Environmental Hazard: No acute aquatic toxicity data available, prudent to handle as potentially harmful to aquatic systems
Label Elements: Signal word: Warning; hazard pictograms: exclamation mark for irritant
Precautionary Statements: Avoid inhalation, wear protective gear, ensure ventilation, wash hands after handling
Chemical Name: Eplerenone
Concentration: ≥98% (Pharmaceutical grade)
CAS Number: 107724-20-9
Impurities and Stabilizers: Typically none at concentrations sufficient to hazard classification; trace process solvents may remain if not produced by GMP-certified source
Inhalation: Remove to fresh air, monitor for respiratory symptoms, seek medical attention if irritation or difficulty breathing develops
Skin Contact: Wash thoroughly with water and mild soap, remove contaminated clothing, consult healthcare if persistent irritation develops
Eye Contact: Rinse cautiously with water for at least 15 minutes, remove contact lenses if possible, obtain medical guidance
Ingestion: Rinse mouth if conscious, do not induce vomiting unless directed by medical personnel, seek immediate medical support
Most Important Symptoms: Respiratory and gastrointestinal irritation, skin redness, eye discomfort
Notes for Physician: Symptomatic treatment, no known specific antidote, monitor cardiac and hepatic status in case of large exposure
Suitable Extinguishing Media: Dry chemical powder, foam, carbon dioxide, or water spray for small fires; avoid direct jet of water
Unsuitable Extinguishing Media: Direct streams of water if fire involves containers with powder, as dispersal may result
Hazardous Combustion Products: Carbon oxides, possibly irritating fumes typical of organic compounds
Protective Equipment: Wear self-contained breathing apparatus, full protective clothing
Special Fire-Fighting Procedures: Control runoff water, avoid spreading powder, isolate fire area if safe to do so, ventilate space post-fire
Personal Precautions: Notify responsible persons, ventilate area, avoid generating airborne dust, wear appropriate respiratory and skin protection
Environmental Precautions: Prevent entry of bulk powder into drains, surface water, or soil
Cleanup Methods: Sweep up without raising dust, collect into labeled containers for disposal, use wet methods if feasible, decontaminate surfaces with mild detergent
Emergency Procedures: Evacuate unnecessary personnel, limit access, refer to site chemical spill protocol for pharmaceutical actives
Precautions for Safe Handling: Minimize dust generation, use in well-ventilated spaces, handle using chemical-resistant gloves and protective eye/face wear
Advice on General Occupational Hygiene: Do not eat, drink, or smoke in work area, wash hands before breaks
Conditions for Safe Storage: Store in tightly sealed original container, in cool, dry place away from light and incompatible materials
Incompatible Materials: Strong oxidizing agents, acids or bases that may degrade active compound
Specific End Uses: Manufacture of finished pharmaceutical products under qualified supervision only
Occupational Exposure Limits: No published international exposure limits for Eplerenone as of latest review
Engineering Controls: Use local exhaust ventilation, enclose processes where possible, maintain negative air pressure in dedicated production spaces
Individual Protection Measures: Chemical-resistant gloves (nitrile or latex), safety glasses with side shields, lab coat, particle-filtering respirator where airborne material may occur
Environmental Controls: Use closed handling and disposal systems, monitor workspace for airborne particles and regular surface cleaning
Appearance: White to off-white crystalline powder
Odor: Odorless or nearly odorless
Melting Point: 246-250°C
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Practically insoluble in water; soluble in acetone, methanol, ethanol, dimethyl sulfoxide
Partition Coefficient (log P): 1.1–1.2 reported
Vapor Pressure: Negligible
Density: Approximately 1.3 g/cm³
pH: Not applicable (non-aqueous solid)
Chemical Stability: Stable under recommended storage conditions
Reactivity: No dangerous reactions expected under normal conditions
Possibility of Hazardous Reactions: None reported under normal handling
Conditions to Avoid: Heat, direct sunlight, sources of ignition, strong moisture
Incompatible Materials: Strong oxidizing agents, acids, bases
Hazardous Decomposition Products: Combustion yields carbon monoxide, carbon dioxide, possible toxic fumes of organic origin
Likely Routes of Exposure: Inhalation, skin and eye contact, accidental ingestion
Acute Toxicity: Data limited, LD50 not characterized in humans, low acute oral toxicity in animal studies
Chronic Toxicity: Based on therapeutic experience, may affect potassium metabolism, mild irritant at high doses
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, OSHA
Reproductive/Developmental Effects: No conclusive experimental data available, not intended for use during pregnancy
Other Exposure Effects: Hypotension, dizziness, headache, rare risk of hyperkalemia following ingestion
Aquatic Toxicity: No specific data for acute or chronic toxicity in aquatic species
Persistence and Degradability: Predicted to be persistent in environment due to low water solubility and stability
Bioaccumulation Potential: Low to moderate based on partition coefficient
Mobility in Soil: Limited by low water solubility, potential for binding to sediment and organic matter
Other Adverse Effects: Not expected to bioaccumulate significantly, but prudent disposal and containment are important for environmental protection
Product Disposal: Dispose of in accordance with national and local regulations as pharmaceutical waste
Packaging Disposal: Rinse thoroughly before recycling or dispose of as hazardous chemical waste
Methods of Disposal: Incineration recommended under controlled, permitted conditions, do not discharge into drains or environment
Considerations for Large Quantities: Notify waste authority, use authorized chemical waste vendor
UN Number: Not regulated as a dangerous good for transport
UN Proper Shipping Name: Not applicable
Transport Hazard Class: Not applicable
Packing Group: Not regulated
Environmental Hazards: Prevent release to environment during transport
Special Precautions for User: Ship in original or secure containers, avoid physical damage, follow company logistics protocols
EU Regulations: Not classified as hazardous chemical under CLP Regulation 1272/2008 for finished product, workplace safety data required for bulk active
US Regulations: Not listed as a hazardous chemical under OSHA, subject to FDA controls as pharmaceutical
Other International Regulations: Handle according to country-specific legislation for pharmaceutical actives, may require reporting under country chemical notification systems
Chemical Safety Assessment: Not required for finished medicinal products, recommended for bulk chemical
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