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Product Name: Paliperidone Palmitate
CAS Number: 199739-10-1
Synonyms: 9-Hydroxy-risperidone palmitate, Invega Sustenna
Recommended Uses: Pharmaceutical preparation, antipsychotic agent
Manufacturer: Manufacturers' details must be verified on the packaging.
Emergency Contact: Consult poison control or emergency services for incidents involving exposure.
GHS Classification: May cause respiratory irritation, can be harmful if swallowed or inhaled
Signal Word: Warning
Hazard Pictograms: Exclamation Mark, Health Hazard
Hazard Statements: Hazardous to tissue after direct contact, can affect central nervous system, may cause skin and eye irritation, environmental accumulation possible
Precautionary Statements: Avoid all unnecessary exposure; wear protective clothing and gloves; do not breathe dust or aerosols; handle in ventilated area
Chemical Name: Paliperidone Palmitate
Concentration: 100% for active pharmaceutical ingredient; formulations may blend with excipients
Impurities: Specifications depend on batch and manufacturing location; check certificate of analysis for detailed breakdown
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes, seek medical attention
Skin Contact: Wash area with soap and water; remove contaminated clothing
Inhalation: Remove to fresh air, assist breathing if needed
Ingestion: Rinse mouth, seek immediate medical attention; do not induce vomiting without professional direction
Suitable Extinguishing Media: Dry chemical, carbon dioxide, foam, water spray for cooling
Special Hazards: May produce toxic fumes of carbon monoxide and nitrogen oxides on combustion
Special Protective Equipment: Firefighters require self-contained breathing apparatus, protective clothing
Additional Advice: Keep containers cool with water spray to minimize risk of explosion or release; avoid firefighting runoff into drains or water supplies
Personal Precautions: Wear full protective clothing, gloves, eye protection; avoid creating dust
Environmental Precautions: Prevent entry into drains or natural waters; scoop or vacuum up to avoid environmental contamination
Methods for Cleaning Up: Collect material mechanically, place in suitable labeled container; ventilate area and wash residues with detergent solution
Handling: Use only in well-ventilated areas, employ engineering controls if dust or aerosols possible; avoid ingestion, inhalation, skin and eye contact
Storage Conditions: Store at controlled room temperature, protected from moisture, light, and incompatible materials; keep containers tightly sealed, secure from unauthorized use
Incompatible Materials: Strong oxidizers, acids, bases
Engineering Controls: Handle in glove box or ducted fume hood, ensure system prevents exposure
Personal Protective Equipment: Safety goggles, NIOSH-approved respirator if dusts/aerosols may occur, chemical-resistant gloves and lab coat
Hygiene Measures: Wash hands after handling; do not eat, drink, or smoke in work area; dispose of contaminated protective equipment safely
Appearance: White to off-white powder
Odor: Not significant
Molecular Formula: C39H57FN4O4
Molecular Weight: 666.9 g/mol
Melting Point: Approximately 110-115°C
Solubility: Insoluble in water, soluble in N,N-dimethylacetamide and dimethyl sulfoxide
pH: Not applicable
Flash Point: Not established for dry powder
Density: Not established; consult manufacturer's specifications
Chemical Stability: Stable under normal conditions of storage and handling
Reactivity: Not reactive under recommended handling
Conditions to Avoid: Excess heat, moisture, exposure to light
Incompatible Materials: Oxidizing agents may degrade product
Hazardous Decomposition Products: May release toxic fumes including carbon monoxide, carbon dioxide, nitrogen oxides under fire or decomposition conditions
Routes of Exposure: Oral, inhalation, dermal, ocular
Acute Toxicity: Harmful if swallowed, inhaled, or absorbed through skin; LD50 not established in humans, effects range from mild sedation to severe CNS effects
Chronic Toxicity: Long-term exposure can cause symptoms typical of antipsychotic drugs: drowsiness, tremors, metabolic changes
Carcinogenicity: Not listed by IARC, NTP, or OSHA as known carcinogen
Other Health Effects: May cause reproductive toxicity, based on animal studies
Ecotoxicity: May be harmful to aquatic organisms, avoid uncontrolled release into environment
Mobility in Soil: Expected low mobility; binds to soil and sediments
Persistence and Biodegradability: Not readily biodegradable; persists in environment
Bioaccumulative Potential: Data insufficient for precise assessment, potential for bioaccumulation cannot be ruled out
Other Adverse Effects: Consult local regulations for pharmaceutical waste; unintended entry into water bodies should be avoided due to drug activity
Waste Treatment Methods: Material must be incinerated in permitted hazardous waste facility; do not dispose of in household or general waste
Contaminated Packaging: Decontaminate and dispose following local, regional, and national regulations
Special Precautions: Must not be released to sewer or environment; consult authorities for advice
UN Number: Not specifically assigned, classified based on local and international shipment regulations
UN Proper Shipping Name: Pharmaceutical Product, not regulated as dangerous goods under IATA, IMDG, or DOT for standard preparations
Transport Hazard Class: Not classified as hazardous for transport; follow packaging directions and documentation requirements
Packing Group: Not applicable
Environmental Hazards: Avoid direct release; transport in sealed, labeled containers
US Regulations: Listed under TSCA with restricted pharmaceutical use; subject to DEA control for certain formulations
International Regulations: Product approved for pharmaceutical use in many countries under controlled prescription; environmental release governed by frameworks such as REACH in Europe
Specific Provisions: Refer to prescribing information for handling and disposal recommendations; comply with pharmaceutical waste and controlled substance rules in region of operation
