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Product Name: Asenapine Maleate
Chemical Formula: C17H16ClNO•C4H4O4
CAS Number: 85650-56-2
Manufacturer: Listed manufacturer contact details
Recommended Use: Pharmaceutical ingredient, antipsychotic compound
Restriction on Use: For laboratory and pharmaceutical manufacturing only
Synonyms: Asenapine hemimaleate
Emergency Number: Refer to manufacturer SDS
Hazard Classification: Not classified as hazardous under GHS for normal handling but can cause health issues if ingested or inhaled
Signal Word: Warning
Hazard Statements: May cause respiratory irritation, may cause skin and eye irritation, potential reproductive toxicity, may affect central nervous system
Precautionary Statements: Avoid inhalation, avoid contact with eyes and skin, use personal protective equipment
Pictograms: Exclamation mark
Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Target Organs: Central nervous system, skin, eyes
Chemical Name: Asenapine Maleate
Percentage: 97-100% active ingredient
CAS Number: 85650-56-2
Impurities/Residual Solvents: Trace amounts of related substances and residual solvents as regulated by pharmacopeial standards
Inhalation: Move person to fresh air, seek medical attention if symptoms develop
Skin Contact: Remove contaminated clothing, flush skin with soap and water for at least 15 minutes, get medical help if irritation develops
Eye Contact: Rinse eyes with water for at least 15 minutes, lift eyelids regularly, contact medical professional
Ingestion: Rinse mouth, never induce vomiting unless directed by professional, seek medical attention immediately
Most Important Symptoms: Respiratory symptoms, skin and eye irritation, neurological symptoms
Immediate Medical Attention: Required if large amounts are swallowed, inhaled, or substantial skin/eye exposure occurs
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Specific Hazards: Toxic fumes of nitrogen oxides, carbon monoxide, hydrogen chloride may form under fire conditions
Protective Equipment: Firefighters must wear self-contained breathing apparatus and protective clothing
Advice for Firefighters: Avoid breathing fumes, keep upwind, use full protective gear, evacuate area if needed
Fire/Explosion Risk: No unusual fire or explosion hazard expected for solid material
Personal Precautions: Wear gloves, goggles, lab coat, NIOSH-approved respirator as needed
Environmental Precautions: Avoid runoff into drains, surface water, and soil
Clean-Up Methods: Sweep up and place in suitable container for disposal, ventilate area, clean contaminated surfaces with water and detergent
Prevention of Secondary Hazards: Use non-sparking tools, avoid creating dust, keep away from incompatible materials
Safe Handling: Operate in a well-ventilated or chemical fume hood, avoid dust generation, avoid direct contact, keep away from incompatible substances
Storage Conditions: Store in a tightly closed container, away from light, moisture, and strong oxidizers, at 2-8°C
Incompatible Materials: Strong oxidizing agents, acids, bases
Handling Precautions: Wash hands after handling, wash contaminated clothing before reuse, keep work area clean
Engineering Controls: Use fume hood or local exhaust, keep airborne levels below occupational exposure limits
Personal Protective Equipment: Protective eyewear, gloves resistant to chemicals, lab coat, respiratory protection if ventilation is inadequate
Occupational Exposure Limit: No established OEL for asenapine maleate; minimize exposure as per good industrial hygiene
General Hygiene Measures: Wash hands, avoid eating, drinking, or smoking in work area, change soiled clothing
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Information not available
pH: Approximately neutral in solution
Melting Point/Range: 200–210°C
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not established
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Relative Density: About 1.2 g/cm³
Solubility: Sparingly soluble in water, soluble in DMSO and methanol
Partition Coefficient (log P): Approximately 3
Vapor Pressure: Not significant
Auto-ignition Temperature: No data available
Decomposition Temperature: Above 200°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions
Reactivity: Does not react under normal temperatures and pressures
Possible Hazardous Reactions: No hazardous polymerization
Conditions to Avoid: Heat, light, moisture, incompatible materials
Incompatible Materials: Strong oxidizers, strong acids, strong bases
Decomposition Products: Toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, and hydrogen chloride may form on combustion or decomposition
Routes of Exposure: Inhalation, skin, eyes, ingestion
Acute Toxicity: Open data on LD50 not available; no indication of acute toxicity at therapeutic doses in humans
Chronic Toxicity: Prolonged exposure can affect central nervous system, cause reproductive toxicity, possible genotoxicity in animal studies
Sensitization: May induce skin sensitization in susceptible individuals
Carcinogenicity: No classification by IARC, NTP, or OSHA
Reproductive/Developmental Toxicity: Animal data suggest possible adverse reproductive effects
Symptoms of Overexposure: Headache, dizziness, nausea, drowsiness, allergic skin reaction, local irritation to eyes
Medical Conditions Aggravated: Pre-existing CNS conditions, allergies, skin disorders
Toxicity: Limited data; expected to present low risk with small-scale laboratory discharge
Persistence/Degradability: Not readily biodegradable
Bioaccumulation Potential: Low potential predicted based on chemical structure
Mobility in Soil: Moderately mobile in aqueous medium
Other Adverse Effects: No indication of significant hazard to aquatic life under normal use
Waste Disposal Methods: Collect and place in a labeled hazardous waste container, follow local, regional, national, and international regulations for disposal
Contaminated Packaging: Dispose of as hazardous waste per federal or state regulations
Special Precautions: Do not discharge into drains, soil, or aquatic environments
UN Number: Not regulated for transport
UN Proper Shipping Name: Not classified
Transport Hazard Class: Non-hazardous for air, sea, road, and rail
Packing Group: Not assigned
Marine Pollutant: No
Transport Precautions: Avoid extreme temperatures, physical damage, and moisture during transport
Safety, Health, and Environmental Regulations: Asenapine maleate complies with specific food and drug administration and pharmaceuticals regulation for research and prescription use
TSCA Inventory: Not listed
SARA Title III (Sections 311/312): No hazard categories
OSHA: Not regulated as hazardous material
WHMIS Classification: Exempt as a pharmaceutical
REACH, RoHS, and Other Standards: Not classified as a persistent, bioaccumulative, or toxic chemical based on current data
