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Product Name: Prasugrel Hydrochloride
Synonyms: CS-747, Effient, Prasugrel HCl
Chemical Family: Thienopyridine anti-platelet agent
Molecular Formula: C20H20FNO3S·HCl
Molecular Weight: 409.90 g/mol (free base)
Recommended Use: Pharmaceutical active ingredient
Manufacturer Information: Refer to specific manufacturer or supplier contact for details
CAS Number: 389574-19-0
GHS Classification: Toxic to reproduction (Category 2); Specific target organ toxicity, repeated exposure (Category 2); Eye irritation (Category 2A); Acute toxicity, oral (Category 4)
Signal Word: Warning
Hazard Statements: Harmful if swallowed; Causes serious eye irritation; May cause damage to organs through prolonged or repeated exposure; Suspected of damaging fertility or the unborn child
Precautionary Statements: Avoid breathing dust; Wear protective gloves/protective clothing/eye protection/face protection; Wash exposed areas thoroughly after handling; If swallowed, seek medical advice; Do not eat, drink, or smoke while using the substance
Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Potential Health Effects: Possible headache, dizziness, mucous membrane irritation, hematological disturbances
Active Substance: Prasugrel Hydrochloride
CAS Number: 389574-19-0
Concentration: 98-100% (pharmaceutical grade)
Impurities: May contain trace synthetic byproducts such as thienopyridine derivatives, regulated within pharmacopoeial limits
Excipients: None in raw drug substance; refer to specific product formulations for tablet or oral dosage excipients
Inhalation: Remove person to fresh air, keep at rest in position comfortable for breathing, seek medical attention for persistent symptoms
Skin Contact: Remove contaminated clothing, wash skin with soap and water for several minutes, obtain medical attention for rash or persistent irritation
Eye Contact: Rinse cautiously with water for at least 15 minutes while holding eyelids open, remove contact lenses if present and easy to do, continue rinsing, seek immediate medical advice
Ingestion: Rinse mouth, do not induce vomiting unless directed by medical personnel, get medical attention immediately
Most Important Symptoms and Effects: Eye redness, irritation, nausea, hematologic symptoms, possible serous toxicity from repeated exposure
Notes to Physician: Treat symptomatically; monitor for signs of bleeding or thrombocytopenia due to antiplatelet activity
Suitable Extinguishing Media: Use foam, dry powder, carbon dioxide, or water spray for small fires; avoid high-pressure water jets
Special Exposure Hazards: Combustion may produce hazardous gases including carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride, sulfur oxides
Protective Equipment for Firefighters: Use self-contained breathing apparatus and full protective gear
Precautions: Avoid inhaling fumes, evacuate area if large quantities involved or fire uncontrolled
Additional Information: Prevent fire-fighting water from entering drains or watercourses; collect separately for disposal
Personal Precautions: Restrict access to area; ventilate; use suitable protective equipment including gloves, goggles, and dust respirator
Environmental Precautions: Prevent entry into drains, sewers, surface, and groundwater; alert authorities in case of spillage to water environment
Methods for Containment: Sweep or scoop up material avoiding dust generation, transfer to suitable containers for disposal
Clean-up Procedures: Decontaminate area with detergent and water; carry out clean-up wearing suitable PPE; dispose of contaminated materials in accordance with regulatory requirements
Handling Precautions: Minimize dust creation; avoid inhalation and skin contact; use in well-ventilated area or chemical fume hood; keep containers tightly closed
Safe Storage: Store at controlled room temperature (15-30°C), away from incompatible substances like strong oxidizing agents, acids, bases
Special Requirements: Store in original labeled packaging; protect from light and moisture; restrict access to qualified personnel; maintain inventory logs per regulatory protocols
Incompatibilities: Avoid exposure to conditions of high humidity and heat
Occupational Exposure Limits: No established OEL for prasugrel; follow internal occupational health standards if available
Engineering Controls: Handle in closed systems, local exhaust ventilation or fume hood
Personal Protective Equipment: Nitrile gloves, protective lab coat, chemical splash goggles, fit-tested NIOSH-approved respirator in dusty environments
Hygiene Measures: Wash hands and exposed skin after handling; change out of contaminated clothing before leaving work area
Environmental Exposure Controls: Implement measures to minimize release into environment
Appearance: White to off-white crystalline powder
Odor: Odorless or faint organic odor
pH: Not applicable (solid)
Melting Point: 128-131 °C (free base)
Boiling Point: Not determined (decomposes)
Solubility: Freely soluble in methanol, ethanol, slightly soluble in water
Partition Coefficient (log P): Estimated 2.5 to 3.0
Vapor Pressure: Not appreciable at room temperature
Density: 1.3–1.5 g/cm³ (estimated)
Flash Point: Not determined
Explosive Properties: No explosive properties predicted
Other: Stable under normal handling and storage conditions
Chemical Stability: Stable under recommended storage conditions; degrade under extended exposure to high temperature, light, moisture
Reactivity: No dangerous reactions known under normal use
Conditions to Avoid: High humidity, direct sunlight, heat, strong acids/bases, oxidizers
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, sulfur oxides, hydrogen chloride
Polymerization: No hazardous polymerization occurs
Acute Toxicity: Harmful if swallowed, LD50 values in animals generally between 200–2000 mg/kg by oral route
Skin Corrosion/Irritation: Mild to moderate skin irritant in animal data
Eye Damage/Irritation: Causes significant irritation in rabbits
Respiratory Sensitization: No human data, not classified as sensitizer
Carcinogenicity: Not classified as human carcinogen by OSHA, IARC, ACGIH, or NTP
Reproductive Toxicity: Animal studies show potential effects on fetal development at high doses
Target Organ Effects: Prolonged exposure may affect hematological system (platelet and bleeding effects)
Signs and Symptoms: Headache, nosebleed, gum bleeding, bruising, eye irritation
Other Toxicological Effects: No known mutagenic potential in standard genotoxicity assays
Ecotoxicity: Shows low to moderate acute toxicity to aquatic organisms, available data indicates LC50 (fish) >100 mg/L
Persistence and Degradability: Not readily biodegradable; may persist in environment
Bioaccumulation: Low potential for bioaccumulation estimated by log Kow
Mobility in Soil: Moderately mobile in soil due to solubility characteristics
Aquatic Release: Avoid discharge to aquatic environments; may lead to long-term adverse effects
Other Adverse Effects: No data on ozone depletion, global warming impact insignificant
Waste Management: Dispose as hazardous pharmaceutical waste according to local, regional, national, and international regulations
Methods of Disposal: Incinerate under controlled conditions; do not flush into drains or natural waterways
Packaging Disposal: Decontaminate packaging before disposal as solid waste; follow site guidelines for cytotoxic or pharmaceutical residues
Special Precautions: Personnel handling disposal should wear full PPE; keep records of waste transfer as per regulation
UN Number: Not regulated as hazardous for transportation under ADR, IMDG, or IATA
Proper Shipping Name: Not regulated
Class/Division: Not regulated
Packing Group: Not regulated
Environmental Hazards: Not a marine pollutant
Special Transport Precautions: Ship in tightly sealed, labeled containers and protect from moisture and excessive heat during transit
International Inventories: Not listed on TSCA; regulated as active pharmaceutical ingredient worldwide
U.S. Regulations: Not listed as hazardous chemical under OSHA; EPA waste code not assigned
EU Regulations: Not classified as dangerous under CLP Regulation 1272/2008; subject to REACH exemptions for medicinal products
Other Information: Handle only by trained personnel in accordance with applicable Good Manufacturing Practice (GMP) guidelines; maintain SDS access at workplace as per Right-to-Know legislation
