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Product Name: Fosaprepitant Dimeglumine
Chemical Family: Antiemetic compound
Molecular Formula: C23H22F7N4O6P·C7H17NO5
Synonyms: Emend for Injection
Recommended Use: Pharmaceutical active ingredient used in prevention of chemotherapy-induced nausea and vomiting
Supplier Name: Pharmaceutical manufacturer or distributor licensed to handle API
Emergency Contact: Use local poison control center or emergency medical contact
Classification: Not classified as hazardous according to GHS criteria for pharmaceuticals in finished dosage form; bulk material may have specific risks
Hazard Pictogram: None for finished product; powder or bulk form should be handled with care
Signal Word: None required for finished pharmaceutical; “Warning” in bulk powder form
Health Hazards: Eye, skin, and respiratory irritant in bulk powder; no significant acute toxicity in recommended doses
Precautionary Statements: Avoid inhalation and contact with skin, eyes, and clothing; use protective equipment in industrial settings
Target Organs: Data suggest liver and gastrointestinal system for overdose or misuse
Chemical Name: Fosaprepitant dimeglumine
CAS Number: 265121-04-8 (Fosaprepitant); 6155-57-3 (Dimeglumine)
Active Ingredient: Fosaprepitant dimeglumine (purity at least 99%)
Impurities: Trace related substances per pharmaceutical standard
Excipients: Not applicable for API; injectables include mannitol, polysorbate 80, sodium hydroxide
Concentration: API vials usually contain 150 mg per vial
Inhalation: Move person to fresh air; obtain medical attention for breathing difficulty
Eye Contact: Rinse eyes with large amounts of water for 15 minutes; do not rub; seek medical advice for persistent irritation
Skin Contact: Remove contaminated clothing; wash exposed skin thoroughly with soap and water
Ingestion: Rinse mouth, drink water if victim is conscious; call physician or local poison control for further instructions
Note to Physicians: Treat symptomatically; monitor for allergic reactions or overdose
Suitable Extinguishing Media: Use water spray, foam, dry chemical, or carbon dioxide
Unsuitable Extinguishing Media: None known for finished dosage; avoid high-pressure water streams on powders
Hazardous Combustion Products: May release toxic fumes of carbon oxides, nitrogen oxides, fluorine compounds, and phosphorus oxides
Special Protective Equipment: Firefighters should wear self-contained breathing apparatus and protective clothing
Additional Information: Dust from powder can create explosive mixtures with air; evacuate area if large volumes involved
Personal Precautions: Wear disposable gloves, lab coat, and dust mask or respirator; avoid generating airborne dust
Environmental Precautions: Prevent spilled product from entering drains, sewers, or watercourses
Clean-Up Procedures: Sweep or scoop up solid material; place in a closed container for disposal; avoid direct contact
Decontamination: Wash area thoroughly with water and suitable detergent
Small Spill: Use absorbent material for liquid forms; use damp cloth for powder spills
Handling: Use in well-ventilated area; avoid breathing dust or aerosol; wear protective gloves, eyewear, and clothing in industrial settings
Storage Conditions: Store at 20-25°C; excursions permitted between 15-30°C; keep container tightly closed
Incompatibilities: Do not store with strong oxidizing agents or incompatible chemicals
Hygiene Measures: Wash hands after handling; do not eat, drink, or smoke where product is handled
Handling Precautions: Avoid generating dust; use mechanical ventilation if necessary
Exposure Limits: No official occupational exposure limits established for API; use pharmaceutical industry guidelines (e.g., OEL Category: 10–100 μg/m³)
Engineering Controls: Use closed systems or local exhaust ventilation
Personal Protective Equipment: Nitrile gloves, safety goggles, lab coat or coverall, and P2 particulate respirator
Hygiene Practices: Change contaminated clothing immediately; wash hands and face thoroughly
Environmental Controls: Use filtration on exhaust systems in manufacturing plants
Appearance: White or off-white crystalline powder
Odor: Odorless
pH: Not applicable unless dissolved
Melting Point: Decomposes before melting; usually above 200°C
Boiling Point: Not available
Solubility: Freely soluble in water; sparingly soluble in methanol
Vapor Pressure: Not applicable
Relative Density: Not established
Other Data: Stable under recommended storage conditions
Chemical Stability: Stable under normal pharmaceutical handling and storage
Hazardous Reactions: No dangerous reactions known under normal conditions
Incompatible Materials: Avoid strong oxidizers and strong acids
Decomposition Products: May produce toxic fumes on thermal decomposition, including NOx, CO, CO₂, fluorinated compounds, phosphorus oxides
Conditions to Avoid: Excessive heat, moisture, light
Acute Toxicity: Not acutely toxic at therapeutic doses; high doses may cause gastrointestinal distress
Routes of Exposure: Inhalation, dermal, eye contact, ingestion
Symptoms: Irritation to eyes, skin, and respiratory tract; high doses cause headache, fatigue, and nausea
Chronic Effects: No evidence of carcinogenicity or mutagenicity from animal studies; long-term exposure data limited
Allergies: Rare allergic skin reactions reported
Reproductive Effects: No evidence of teratogenicity at therapeutic exposure
Sensitization: Not expected to be a respiratory or skin sensitizer
Ecotoxicity: Not expected to be acutely toxic to aquatic or terrestrial organisms
Persistence and Degradability: Not readily biodegradable; pharmaceutical compounds may persist in aquatic environments
Bioaccumulative Potential: Low bioaccumulation potential based on mobility and physical properties
Mobility in Soil: Compound expected to be mobile in soil; may leach into groundwater if not properly contained
Other Environmental Hazards: Release in large quantities may be hazardous to aquatic life; report significant spills to authorities
Waste Treatment Methods: Dispose by incineration or through authorized pharmaceutical waste contractors
Contaminated Packaging: Dispose of as hazardous chemical waste
Do Not: Flush unused product down sink or toilet
Regulatory Compliance: Follow federal, state, and local environmental regulations on pharmaceutical waste
Precaution: Never reuse empty containers for other purposes
UN Number: Not regulated as a hazardous material
Proper Shipping Name: Pharmaceutical products, n.o.s. (not otherwise specified)
Transport Hazard Class: Not assigned
Packing Group: Not applicable
Labeling Requirements: None for Finished Pharmaceutical Product; bulk shipments should declare substance
Special Precautions: Protect from excessive heat and moisture during transport
Inventory Status: Registered as a pharmaceutical substance; listed in regulatory databases
Regulatory Status: Approved or under review by regulatory agencies (FDA, EMA, etc.) for pharmaceutical use
Hazard Symbols: Not classified as hazardous for finished form
SARA/OSHA/TSCA: Not subject to SARA Title III, not listed on TSCA for consumer use
Other Regulations: Must be handled by licensed personnel; subject to strict pharmaceutical controls for distribution and storage
Labeling: Follows FDA/EMA labeling requirements for finished medicines
Workplace Classification: Occupational exposure banding applies for API powder
