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Product Name: Mifepristone
Chemical Name: 17β-Hydroxy-11β-(4-dimethylaminophenyl)-17α-(1-propynyl)estra-4,9-dien-3-one
Synonyms: RU486, Mifegyne
CAS Number: 84371-65-3
Molecular Formula: C29H35NO2
Molecular Weight: 429.6 g/mol
Intended Use: Pharmaceutical ingredient, research chemical
Manufacturer/Supplier Identification: Name, address, and emergency contact number of the supplier must be kept available at the workplace.
GHS Classification: Reproductive toxicity (Category 1B), Acute Toxicity (Oral, Category 4), Skin irritation (Category 2)
Signal Word: Danger
Hazard Statements: May damage fertility or the unborn child, Causes skin irritation, Harmful if swallowed, May cause respiratory irritation
Precautionary Statements: Wear protective gloves/protective clothing/eye protection/face protection, avoid breathing dust, wash thoroughly after handling, do not eat, drink or smoke when using this product
Other Hazards: Not classified as a flammable solid, possible effects on hormone balance in humans
Component: Mifepristone
Concentration: 98-100% (Active Pharmaceutical Ingredient grade)
Impurities: Typical pharmaceutical impurities lower than 1% each, detailed in certificate of analysis provided by supplier
Additives: None in API grade; formulated products contain excipients as per individual specification
Eye Contact: Rinse with water for at least 15 minutes, remove contact lenses if present and continue rinsing, seek medical attention without delay
Skin Contact: Remove contaminated clothing, wash exposed areas thoroughly with soap and water, consult a physician if symptoms occur
Inhalation: Move person to fresh air, provide oxygen if breathing becomes difficult, obtain medical help if symptoms persist
Ingestion: Rinse mouth with water, do not induce vomiting, seek medical attention promptly
Most Important Symptoms: Hormonal disturbances, gastrointestinal discomfort, dizziness, potential harm to pregnant women
Notes for Physician: Treat symptomatically and supportively; specific antidote not available
Suitable Extinguishing Media: Dry chemical powder, carbon dioxide, foam, water spray
Unsuitable Extinguishing Media: Direct stream of water may spread fire
Special Hazards: Combustion generates toxic and irritating fumes such as carbon monoxide, nitrogen oxides
Protective Equipment for Firefighters: Self-contained breathing apparatus and full protective clothing recommended
Fire/Explosion Risks: Not classified as flammable, but dust formation may pose a risk of combustion in rare cases
Personal Precautions: Use personal protective equipment as required, avoid breathing dust, evacuate unnecessary personnel
Environmental Precautions: Prevent contamination of drains, sewers, waterways, and soil
Methods for Clean-Up: Contain spill, sweep or vacuum up material and place in suitable closed containers, avoid creating dust, ventilate area well, wash spill site thoroughly after material pickup is complete
Handling: Handle in closed systems where possible, wear recommended PPE, wash hands after handling, minimize dust generation, avoid exposure if pregnant or planning pregnancy
Storage: Keep containers tightly sealed in a cool, dry, well-ventilated area dedicated to pharmaceuticals, avoid exposure to moisture, light, and incompatible substances, store away from foodstuffs and out of reach of unauthorized personnel
Incompatible Materials: Strong oxidizing agents, strong acids and bases
Storage Temperature: Typically store at 15-30°C
Engineering Controls: Use with adequate ventilation, work inside chemical fume hoods when handling powders or during weighing and dispensing, local exhaust recommended
Personal Protective Equipment: Chemical-resistant gloves (nitrile, neoprene), safety goggles or face shield, disposable lab coat or protective gown, dust mask or NIOSH-approved respirator for dust exposure
Hygiene Measures: Do not eat, drink or smoke in area, wash hands and face before breaks and at end of shift, remove and wash contaminated clothing before reuse
Recommended Exposure Limit: No established occupational exposure limit, but minimize exposure to as low as reasonably achievable (ALARA) for pharmaceutical active substances
Appearance: White to off-white crystalline powder
Odor: Odorless or very faint odor
pH: Not applicable in solid form
Melting Point: Approximately 192–196 °C
Boiling Point: Decomposes before boiling
Solubility: Practically insoluble in water, soluble in organic solvents such as ethanol, methanol, DMSO, chloroform
Vapor Pressure: Negligible
Partition Coefficient (log P): Approximately 3.6
Density: Around 1.3 g/cm³
Chemical Stability: Stable under recommended storage conditions, sensitive to light and moisture
Reactivity: No data indicating violent reactivity under normal handling, avoid contact with oxidizing agents, acids, bases
Conditions to Avoid: Exposure to heat, light, moisture, and incompatible materials
Hazardous Decomposition Products: May form carbon monoxide, carbon dioxide, nitrogen oxides, and other toxic fumes during combustion or decomposition
Hazardous Polymerization: Does not occur
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Oral LD50 (rat): approximately 2000 mg/kg, considered harmful if swallowed
Chronic Effects: May cause reproductive toxicity; animal studies show teratogenicity, embryotoxicity, affects hormone levels
Irritation: May cause skin and eye irritation
Sensitization: Not established; handle as potential allergen
Mutagenicity/Carcinogenicity: No evidence of genotype effects, no carcinogenicity in animal studies
Other Data: Avoid exposure by persons who are pregnant or trying to conceive, based on mechanism of action and risk for fetal harm
Ecotoxicity: No comprehensive studies; related steroidal compounds have shown some aquatic toxicity, potential risk to aquatic organisms if released in large quantities
Persistence and Degradability: Not readily biodegradable, expected to persist in the environment
Bioaccumulative Potential: Potential for accumulation in aquatic organisms due to log P value, practical significance limited by low volumes in use
Mobility in Soil: Low to moderate mobility, insoluble in water but possible migration in soil via contaminated dust
Other Adverse Effects: Keep product out of waterways, minimize contamination of environment
Waste Disposal Methods: Dispose of in accordance with local, regional, and national regulations for pharmaceutical waste, incineration in licensed facility preferred
Contaminated Packaging: Triple rinse and dispose of as hazardous waste, do not reuse containers
Special Precautions: Do not flush unused material or contaminated rinse water into sewer, minimize environmental release
UN Number: Not regulated for transport under most international and national guidelines (non-hazardous chemical for transport)
Transport Hazard Class: Not classified as hazardous for transport
Packing Group: Not assigned
Proper Shipping Name: Pharmaceuticals, N.O.S. (not otherwise specified) or as directed by regulatory body
Special Precautions: Ship in tightly sealed containers, protected from physical damage, temperature extremes, and away from incompatible substances; transport only by authorized handlers
US Federal Regulations: Not listed as a controlled substance; subject to FDA pharmaceutical regulations, DEA registration for clinical or research use, TSCA-exempt for pharmaceutical use
EU Regulations: Covered by REACH exemption for medicinal products, subject to GMP and pharmacovigilance guidelines, classified for reproductive toxicity under CLP (Regulation (EC) No 1272/2008)
International Regulations: WHO Essential Medicines List; varies by country, including prescription and restricted substance classifications
Labelling Requirements: Pharmaceutical labelling standards apply: product name, batch number, expiry, warning about pregnancy risk, handling precautions
Other Requirements: Users must comply with workplace safety, disposal, and access restrictions for reproductive health risks
