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Product Name: Relugolix
Synonyms: TAK-385, Orgovyx
Chemical Formula: C29H27F2N7O5S
Molecular Weight: 627.64 g/mol
CAS Number: 737789-87-6
Recommended Use: Active pharmaceutical ingredient used in treatments involving hormone-sensitive cancers and uterine fibroids.
Manufacturer: Information varies by commercial distributor.
Emergency Contact: Refer to manufacturer or distributor contact sheet.
GHS Classification: Eye irritation category 2A; Reproductive toxicity category 1B; Specific target organ toxicity (single exposure) category 3
Signal Word: Danger
Hazard Statements: Causes serious eye irritation; may damage fertility or the unborn child; may cause respiratory irritation.
Pictograms: Health hazard, exclamation mark
Precautionary Statements: Avoid breathing dust or powder, wash hands after handling, use protective eye protection, obtain special instructions before use.
Other Hazards: Not combustible, but decomposition products may include hazardous fumes.
Active Ingredient: Relugolix
Purity: >98%
Impurities: Trace process-related impurities below regulatory thresholds
Excipient Presence: None in raw API form
Chemical Class: GnRH antagonist
Inhalation: Remove individual to fresh air; seek medical attention if symptoms develop.
Skin Contact: Remove contaminated clothing; wash contacted skin with soap and plenty of water; seek medical attention for rash or irritation.
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses; continue rinsing; seek medical attention as needed.
Ingestion: Rinse mouth with water; never induce vomiting; seek medical attention immediately.
Most Important Symptoms: Irritation to eyes, respiratory tract discomfort, possible reproductive risks with repeated exposure.
Suitable Extinguishing Media: Use dry chemical, CO2, water spray, or alcohol-resistant foam.
Specific Hazards: Potential for toxic fumes of nitrogen oxides, carbon oxides, sulfur oxides, and fluorine-containing compounds.
Advice for Firefighters: Wear self-contained breathing apparatus and full protective gear. Avoid inhalation of combustion products.
Fire/Explosion Hazards: Product does not present a clear explosion hazard, but fine dust can accumulate and pose a risk under certain conditions.
Flammability: Solid; not easily ignited.
Personal Precautions: Use recommended PPE including gloves, lab coat, and safety goggles; limit dust generation.
Environmental Precautions: Prevent further leakage or spillage if safe to do so; do not discharge into drains or waterways.
Cleanup Methods: For small spills, collect carefully with an appropriate tool and place in a suitable waste chemical container; for larger spills, use HEPA-filter vacuum or dampen powders before collection to reduce airborne particles.
Disposal: Place collected material in designated hazardous waste containers for proper disposal according to local, state, and federal regulations.
Handling: Handle in a ventilated space, minimize dust formation, use PPE like gloves and safety glasses, avoid direct contact with product, prevent ingestion or inhalation of dust.
Storage: Store in tightly closed original container, in a cool, dry, well-ventilated, and secure area; keep away from incompatible materials like strong oxidizing agents.
Incompatibilities: Strong acids, strong bases, and oxidizers.
Special Precautions: Protect from direct sunlight and humidity to preserve chemical integrity.
Exposure Limits: No established occupational exposure limits specific to relugolix; use precautionary principle in absence of data.
Engineering Controls: Process in enclosed systems or chemical fume hoods to minimize airborne exposure; maintain standard laboratory safety wash stations.
Personal Protective Equipment: Nitrile gloves, laboratory coat or disposable over-garments, eye protection (safety glasses or goggles), NIOSH-approved particulate respirator if risk of dust inhalation arises.
Environmental Protections: Use spill control and containment policies in laboratory or storage settings; avoid uncontrolled environmental release.
Appearance: White to off-white crystalline powder
Odor: Odorless or nearly odorless
pH: Not applicable (practically insoluble in water)
Melting Point/Range: 112-117°C
Boiling Point: Decomposes before boiling
Flash Point: Not determined
Solubility: Slightly soluble in organic solvents; practically insoluble in water
Partition Coefficient (log Kow): No data available
Vapor Pressure: Not expected to be volatile at room temperature
Density: Approx. 1.52 g/cm³
Chemical Stability: Stable under standard conditions of storage and handling.
Reactivity: No dangerous reactions expected under normal conditions.
Hazardous Reactions: No polymerization.
Conditions to Avoid: Excessive heat, ignition sources, prolonged exposure to air and moisture.
Incompatible Materials: Strong oxidizing agents, acids, and bases.
Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide, sulfur oxides, toxic fluorinated compounds.
Acute Toxicity: Limited data available for direct oral, dermal, or inhalation exposure; animal studies reflect low acute toxicity.
Chronic Exposure Risks: Evidence of reproductive and developmental toxicity in preclinical studies; avoid chronic occupational exposure.
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion.
Symptoms: Eye and airway irritation; possible disruption to hormone balance with repeated exposure.
Carcinogenicity: No adequate data in humans; animal studies have not established carcinogenicity.
Other Effects: Alterations in endocrine function possible if mishandled.
Ecotoxicity: Harmful to aquatic life, potential for endocrine disruption in water systems.
Persistence and Degradability: Expected to have moderate persistence based on chemical structure.
Bioaccumulative Potential: Low to moderate risk of bioaccumulation; more research needed for definitive risk.
Mobility in Soil: Low, based on low water solubility.
Other Negative Effects: Avoid release to environment; do not flush product or waste to public waterways.
Waste Treatment Methods: Treat as hazardous chemical waste; follow all federal, state, and local regulations for disposal.
Product Disposal: Entrust unused or contaminated material to licensed chemical waste disposal contractor.
Container Disposal: Containers should be triple rinsed and then disposed of in accordance with local environmental control rules.
Special Precautions: Do not discharge into drains, surface water, or soil.
UN Number: Not classified as dangerous for transport.
UN Proper Shipping Name: Not regulated.
Transport Hazard Class: Not applicable.
Packing Group: Not applicable.
Environmental Hazards: None under normal shipping conditions.
Special Precautions for Transport: Ensure secure, sealed secondary containment; avoid rough handling.
Regulatory Status: Pharmaceutical active regulated by agencies in relevant jurisdictions (FDA, EMA, etc.).
OSHA Status: Not specifically listed; handle under good laboratory practice standards.
TSCA (Toxic Substances Control Act): Not listed for general use.
EU REACH: Registration numbers and classification required for bulk handling.
Other Information: Ensure compliance with local, national, and international chemical safety and environmental protection laws; maintain accurate safety documentation accessible to workers.
