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Product Name: Paliperidone
Chemical Name: 9-hydroxy-risperidone
Synonyms: Invega, 9-OH-Risperidone
CAS Number: 144598-75-4
Molecular Formula: C23H27FN4O3
Intended Use: Pharmaceutical ingredient used mainly for antipsychotic medication
Manufacturer Information: Information provided on commercial packaging or through supplier directory
Contact Information: Emergency contacts listed on container, usually through corporate pharmaceutical safety office
Recommended Use: Use typically for research, manufacturing of medications, and clinical settings under strict medical supervision
GHS Classification: Not classified as hazardous for general handling in laboratory quantities
Label Elements: No pictograms or signal words required under GHS for standard use
Hazard Statements: May cause irritation to eyes, skin, and respiratory system if mishandled
Precautionary Statements: Wear gloves, protective clothing, and face protection in laboratory settings
Health Effects: Possible mild irritation from dust or accidental exposure; chronic effects from occupational exposure not fully established
Environmental Hazards: No evidence of acute environmental risk at pharmaceutical concentrations
Routes of Exposure: Skin contact, inhalation, accidental ingestion
Main Ingredient: Paliperidone – purity greater than 98% as active substance
Other Ingredients: Trace residuals may be present from manufacturing, such as solvents; level falls below safety thresholds for worker exposure
Impurities: Less than 1% total, includes related substances from synthetic process
Stabilizers or Additives: No routine stabilizers, sometimes processed alongside pharmaceutical excipients if formulated as a finished medicinal product
Inhalation: Move exposed person to fresh air; seek medical help if symptoms persist, such as coughing or labored breathing
Skin Contact: Wash with plenty of water and soap, remove contaminated clothing; contact physician for persistent irritation
Eye Contact: Rinse eyes thoroughly for at least ten minutes under running water while holding eyelids apart; medical attention if discomfort continues
Ingestion: Rinse mouth, consult doctor immediately, never induce vomiting unless directed by medical staff
Most Important Symptoms: Minor irritation or allergy in sensitive individuals, possible headache, drowsiness in rare exposure
Immediate Medical Attention: Receive medical evaluation if unusual symptoms develop or large exposure occurs
Suitable Extinguishing Media: Water spray, dry powder, carbon dioxide, or foam
Unsuitable Media: Do not use strong water jets which may spread material
Hazardous Combustion Products: Carbon monoxide, nitrogen oxides, hydrogen fluoride, unidentified organic fragments
Firefighter Protection: Wear self-contained breathing apparatus with full protective suit
Flashpoint: Not applicable, not classified as highly flammable
Special Hazards from Fire: Fine dust may pose a flammability risk in cloud if dispersed in air near ignition source
Personal Precautions: Avoid breathing dust; use appropriate respirator and gloves; clear staff not involved from area
Environmental Precautions: Prevent entry into drains, surface water, or soil; contain spill at source
Cleanup Methods: Scoop up using non-sparking tools, sweep up without raising dust, collect for disposal in closed, labeled container
Disposal Guidance: Dispose of via licensed waste contractor, follow local pharmaceutical handling protocols
Reporting Requirements: Notify occupational health office or local authorities if significant spill occurs in industrial setting
Safe Handling Advice: Work in well-ventilated area, use fume hood for procedures that may generate dust, avoid direct skin or eye contact
Hygiene Practices: Wash hands thoroughly after working, prohibit eating or drinking in handling area, avoid inhaling fine particles
Storage Conditions: Store in cool, dry location away from incompatible materials, tightly sealed in original container
Incompatible Materials: Strong oxidizers, acids, or bases
Packaging Materials: Keep in pharmaceutical-grade polyethylene or glass container
Storage Temperature: Room temperature between 15–30°C, away from direct sunlight
Occupational Exposure Limits: Not assigned a specific workplace exposure limit, keep exposure as low as possible
Engineering Controls: Fume hood or local exhaust ventilation for dusty operations
Personal Protective Equipment: Safety goggles, nitrile gloves, laboratory coat, respirator in case of high dust or processing quantities
Environmental Exposure Controls: Implement procedures to contain contaminated air or water, prevent release into public sewer systems
Workplace Monitoring: Use air sampling or swabbing in high-risk pharmaceutical manufacturing
Physical State: White or off-white powder or crystalline solid
Odor: Odorless or faint organic smell
Molecular Weight: 426.5 g/mol
pH (solution): Not available; not routinely measured outside finished pharmaceutical
Melting Point: 176–178°C
Boiling Point: Not available; decomposes before boiling
Solubility: Slightly soluble in water, soluble in methanol and dimethyl sulfoxide
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Kow): 2.6–3.0 (estimation)
Decomposition Temperature: Above 200°C
Viscosity: Not applicable (solid material)
Evaporation Rate: Not applicable
Chemical Stability: Stable under recommended storage and handling conditions
Hazardous Reactions: Unlikely under normal use; vigorous reaction may occur with strong oxidizers
Conditions to Avoid: Excess heat, moisture, strong light, open flames
Incompatibilities: Strong acids, bases, oxidizing agents
Hazardous Decomposition: Produces toxic vapors of nitrogen oxides, carbon monoxide, and fluorinated compounds on burning
Polymerization: Will not occur
Acute Toxicity: Low acute toxicity based on animal test data, clinical use experience
Irritation: May cause minor irritation to eyes, respiratory tract, and skin in sensitive persons
Chronic Exposure: No current evidence for chronic toxicity at occupational levels; therapeutic adverse effects include movement disorders, weight gain, or endocrine changes
Mutagenicity: Negative in standard Ames test and mammalian cell assays
Carcinogenicity: Not classified as carcinogen by IARC or other bodies
Reproductive Toxicity: No evidence of teratogenicity or developmental risk at occupational levels, effects considered for therapeutic exposure
Target Organs: None identified for incidental exposure
Eco-Toxicity: Paliperidone has low predicted aquatic toxicity at environmental levels found from human pharmaceutical use
Persistence and Degradability: Stable compound, slow to biodegrade in water or soil
Bioaccumulation Potential: Low risk due to low environmental concentrations
Mobility in Soil: May be mobile in water if spilled in large amounts, not routine risk from standard labs or pharmacies
Other Adverse Effects: No major risk of ozone depletion or significant impact on nutrient cycles in water or soil
Waste Treatment Methods: Send bulk waste to incineration with approved hazardous waste contractor
Disposal of Containers: Rinse empty containers, dispose of as pharmaceutical waste, do not reuse
Sewage Disposal: Avoid discharge to sewage or surface water without proper neutralization
Special Precautions: Follow protocols for hazardous pharmaceutical disposal in accordance with local laws and regulations
Waste Code: Standard, non-halogenated pharmaceutical waste (check local codes for confirmation)
UN Number: Not regulated as a dangerous good for transport by road, air, or sea
Proper Shipping Name: Pharmaceutical Preparation (Paliperidone)
Transport Hazard Class: Not classified
Packing Group: Not classified
Safety Precautions: Protect from physical damage, moisture, and direct sunlight; deliver in original container
Special Transport Notes: Adhere to GMP handling during all transfers
Regulatory Status: Approved as active pharmaceutical ingredient by US FDA and European Medicines Agency
Labeling Requirements: Pharmaceutical labeling according to FDA, EMA, and local directives
Chemical Inventory Status: Listed in relevant pharmaceutical ingredient catalogs
SARA Title III: Not listed
OSHA Hazards: Not classified under routine occupational standards
REACH Registration: Included in European registers for authorized medicinal use
Other Regulatory Standards: Complies with ICH and WHO guidance on pharmaceutical safety
Restrictions: Prescription-only for clinical or pharmaceutical industry use
Worker Training: Occupational safety and health training provided by employer, based on level of exposure and site risk assessment
