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Product Name: Risperidone
Chemical Name: 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
CAS Number: 106266-06-2
Recommended Use: Antipsychotic medication for mental and mood disorders
Manufacturer/Supplier: Pharmaceutical suppliers, pharmacies, hospital pharmacies
Contact Information: Emergency phone number provided through local poison control or supplier
Classification: Harmful if swallowed, irritating to skin and eyes, may cause respiratory irritation and allergic reactions, long-term exposure may be linked to reproductive toxicity, neurotoxicity, and endocrine disruption
Label Elements: Warning symbol for toxicity; hazard statements for ingestion, eye/skin exposure, environmental release
Most Important Hazards: Repeated or prolonged exposure can cause central nervous system effects, possible allergic response in some workers, may trigger pre-existing skin or respiratory conditions
Other Hazards: Accidental spills pose danger to aquatic environments due to poor biodegradability
Main Ingredient: Risperidone 100% (active pharmaceutical ingredient)
Impurities: Process impurities below 0.1%, residual solvents meeting standard pharmaceutical specifications
Formulation Additives: Usually pure API in laboratory or raw form; commercial tablets may contain lactose, cellulose, magnesium stearate, coloring agents as per product design
Inhalation: Move person to fresh air, provide oxygen or artificial respiration if breathing is difficult, seek emergency medical attention
Skin Contact: Remove contaminated clothing, wash skin thoroughly with soap and plenty of water, seek medical attention for persistent irritation
Eye Contact: Rinse eyes immediately with plenty of water for at least 15 minutes, lift eyelids occasionally, get medical help if irritation continues
Ingestion: Rinse mouth, do not induce vomiting unless directed by medical personnel, seek immediate medical attention, provide information about substance
Suitable Extinguishing Media: Dry chemical powder, CO₂, foam, water spray for small fires; use flood methods for larger consequences involving extensive packaging
Special Hazards: Burning releases toxic fumes including nitrogen oxides, carbon monoxide, hydrogen fluoride, and organic vapors
Protective Equipment: Firefighters wear self-contained breathing apparatus, full protective gear, avoid inhalation of combustion products
Other Information: Remain upwind and evacuate area if necessary
Personal Precautions: Use personal protective equipment, prevent inhalation and skin/eye contact, evacuate unprotected personnel
Environmental Precautions: Prevent entry into waterways, sewers, drains; contain and collect spill; report major releases to environmental authorities
Methods for Clean-up: Scoop up, use disposable towels or inert absorbent, place in suitable closed containers for proper disposal, wash spill area with water and detergent, ventilate
Handling: Avoid contact with eyes, skin, clothing; avoid swallowing, inhaling dust; use within designated containment area; employ proper engineering controls such as ventilated hoods
Storage: Store in tightly closed original container at 20–25°C (68–77°F) away from light, heat, and incompatible materials; keep out of reach of children; maintain log for receipt, use, and disposal in research facilities
Exposure Limits: Occupational exposure limit not specifically established, minimize exposure as recommended for pharmaceuticals
Engineering Controls: Mechanical ventilation, fume hoods, local exhaust systems in preparation or handling areas
Personal Protective Equipment: Protective lab coat or gown, gloves (nitrile preferred), safety goggles, disposable masks or respirator if dust may form; wash hands before eating or drinking, do not smoke in handling areas
Appearance: White to off-white powder, odorless
Molecular Formula: C23H27FN4O2
Melting Point: 170–180°C
Solubility: Practically insoluble in water, soluble in methanol, DMSO
Molecular Weight: 410.48 g/mol
Vapor Pressure: Not significant at ambient temperatures
pH: Not applicable for solid API
Boiling Point: Decomposes before boiling
Density: Not determined in open literature
Flash Point: Not specifically reported, handle as combustible solid
Stability: Stable under normal conditions when stored properly
Incompatible Materials: Strong acids, strong bases, oxidative agents
Hazardous Decomposition Products: Toxic fumes of nitrogen oxides, carbon oxides, hydrogen fluoride on thermal decomposition
Polymerization: No hazardous polymerization expected
Conditions to Avoid: Prolonged exposure to moisture, heat, and light accelerates decomposition and loss of potency
Acute Toxicity: Oral LD50 in rats: estimated between 130–2500 mg/kg; human overdose linked to cardiovascular and central nervous system depression
Inhalation: Limited evidence in humans, possible drowsiness, dizziness, headache, respiratory irritation from acute exposure
Skin/Eye Irritation: Moderate to strong irritation reported in animal studies, sensitization in susceptible workers; redness, rash, itching
Chronic Effects: Agitation, involuntary movement disorders, weight changes, elevated prolactin, possible impacts on reproductive organs at high doses
Carcinogenicity/Mutagenicity: Not classified as known carcinogen by OSHA, NTP, IARC; no mutagenic effects noted in standard assays
Reproductive Toxicity: Potential risk with repeated high-dose exposure over long periods to unborn children; evidence of developmental toxicity in animal models
Toxicity: High toxicity to aquatic organisms including algae, daphnia, and fish at low concentrations, prevents growth and disrupts ecological cycles
Persistence and Degradability: Poorly biodegradable, stable in surface waters for extended periods, accumulates in sediment
Bioaccumulation: Evidence suggests low to moderate potential for bioaccumulation in aquatic life
Mobility in Soil: Moderate mobility possible, tendency for leaching and limited adsorption to particles, potential threat to groundwater
Other Adverse Effects: Entry into environment should be prevented by all reasonable means
Waste Methods: Incinerate material at licensed chemical incineration facility, observe all regulatory guidelines for hazardous and pharmaceutical waste
Contaminated Packaging: Dispose of empty containers as pharmaceutical waste after triple rinse, do not reuse, label and seal before handover to authorized disposal site
Precautions: Personnel handling waste must wear full protective gear, trained in spill response and environmental protection, minimize dust generation and inhalation
UN Number: Not classified under Transport of Dangerous Goods for limited lab/research use
Proper Shipping Name: Risperidone, pharmaceutical, not otherwise specified
Hazard Class: Not regulated as dangerous good in standard forms; large bulk raw supply may need special handling
Packing Group: Not assigned; use sturdy, sealed containers to prevent breakage and leak
Environmental Precautions: Prevent leaks or spillage during transit, especially for bulk supplies, notify authorities if accidental release occurs en route
TSCA Status: Not listed on US EPA Toxic Substances Control Act chemical inventory
OSHA: Not specifically listed, treat as hazardous due to toxicological profile
WHMIS: D2A (Very toxic materials); D2B (Toxic material causing other effects) under Canadian WHMIS
EC Classification: Harmful (Xn), R22 (Harmful if swallowed), R36/37/38 (Irritating to eyes, respiratory system, and skin)
Other Applicable Laws: Controlled under prescription drug regulations by national health agencies, subject to reporting and tracking in manufacturing and transit
