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Product Name: Quetiapine Fumarate
Chemical Name: 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol fumarate
Common Uses: Prescription antipsychotic, largely for conditions like schizophrenia, bipolar disorder, and adjunct in major depression
Form: Often a white or off-white powder; formulated as tablets for patient use
CAS Number: 111974-72-2
Appearance: Powder, characterized by very slight solubility in water and mild odor
GHS Classification: Not universally classified as hazardous, but carries health risks through ingestion, inhalation, and skin absorption
Acute Health Effects: Drowsiness, hypotension, tachycardia, possible risk of coma in significant overdose
Chronic Health Effects: Long-term exposure may provoke metabolic issues, weight gain, and altered cardiac rhythms
Eye Contact: Irritation, redness possible
Skin Contact: Mild irritation in sensitive individuals
Environmental Hazards: Potentially persistent in aquatic settings, not highly biodegradable
Main Component: Quetiapine Fumarate
Percent Purity: Frequently above 98% in pharmaceutical form
Impurities: Trace organic synthesis byproducts possible, subjected to regulatory standards for raw material safety
Additives: Formulations may contain excipients like lactose, microcrystalline cellulose, magnesium stearate—specifics vary by manufacturer and tablet strength
Inhalation: Move to fresh air immediately; seek medical treatment for serious respiratory symptoms
Skin Exposure: Remove contaminated clothing, rinse skin thoroughly with water and soap; medical attention for persistent redness or rash
Eye Contact: Rinse eyes gently with running water; obtain medical advice if irritation continues
Ingestion: Rinse mouth, do not induce vomiting without medical direction; seek immediate medical evaluation due to potential CNS depression and cardiovascular effects
Suitable Extinguishing Media: Dry chemical, carbon dioxide, foam, or water spray
Hazardous Combustion Products: Emits carbon monoxide, carbon dioxide, nitrogen oxides, and sulfur oxides when burned
Protective Equipment for Firefighters: Full protective gear with self-contained breathing apparatus recommended in cases of large-scale fire or dense smoke
Fire Hazards: Powder may be combustible if exposed to open flame or high temperatures, though not especially reactive
Personal Precautions: Wear gloves, eye protection, and dust mask to prevent exposure
Environmental Precautions: Avoid release into drains and waterways; scoop up spillage with care to avoid dust generation
Cleanup Methods: Ventilate if indoors, collect using non-sparking tools, place in appropriate closed container for disposal
Safe Handling: Use in well-ventilated areas, avoid generating dust; after handling, wash hands and exposed skin thoroughly
Storage Conditions: Store in tightly closed, original container, protected from heat, moisture, and direct sunlight; maintain temperature as specified in pharmaceutical labeling, usually below 25°C
Exposure Limits: No occupational exposure limits established in most countries for active pharmaceutical ingredients like quetiapine fumarate
Engineering Controls: Local exhaust ventilation recommended for manufacturing environments
Personal Protective Equipment: Protective gloves, lab coat, safety glasses; dust mask or respirator in case of powder formation or dust
Hygiene Considerations: Prohibit food, drinks, and smoking in handling areas; implement skin and respiratory protection policies
Physical State: Solid powder
Color: White or faintly off-white
Odor: Slight, almost unnoticeable
Solubility in Water: Very low, though slightly more soluble in organic solvents
Melting Point: Approx. 175-177°C
Boiling Range: Thermally decomposes before boiling
pH: Typically neutral to slightly basic in an aqueous solution
Chemical Stability: Stable under recommended storage conditions; degrades in presence of strong acids, bases, and oxidizing agents
Hazardous Decomposition Products: Exposed to fire or prolonged heat, produces sulfur oxides, nitrogen oxides, and other toxic gases
Reactivity: No known violent reactivity under normal processing and storage conditions
Routes of Exposure: Most commonly via ingestion; possible effects through inhalation, skin, and eye contact in manufacturing environment
Acute Toxicity: Overdose may cause sedation, cardiac disturbances, respiratory depression, and in some cases, seizures
Chronic Toxicity: Long-term exposure for healthcare workers might lead to cumulative neuropsychiatric or metabolic impacts; reproductive risk evidence remains limited
Carcinogenicity: No strong evidence for human carcinogenicity based on available studies
Other Health Effects: Allergic reactions and skin sensitivity can occur, especially in workers with regular exposure to raw powder
Aquatic Toxicity: Not acutely toxic to aquatic life at typical concentrations, but can build up due to poor biodegradability
Persistence and Degradability: Resistant to breakdown in water and soil, may persist in wastewater and treatment systems
Bioaccumulation: Potential for low-level accumulation in aquatic species over time
Mobility in Soil: Low, given limited solubility and tendency to adsorb to organic matter
Waste Disposal: Collect unused material and contaminated packaging in sealed, labeled containers; incinerate at licensed facility if local regulations permit
Drain Disposal: Strictly discouraged to prevent pharmaceutical contamination downstream
Recycling: Not suitable—pharmaceutical actives ought to be managed as hazardous waste for environmental safety
UN Number: Typically not regulated as a dangerous good for transportation under common chemical shipping regulations
Packing Group: Not assigned for this substance
Shipping Precautions: Keep packaging tight, avoid spillage and exposure to weather; comply with pharmaceutical shipping requirements in jurisdiction of use
Regulatory Status: Prescription-only medicine, subject to national and international controls
Occupational Safety: Many jurisdictions mandate risk assessments and training for workers routinely handling large amounts
Chemical Control: Registered for medical use; certain countries specify workplace exposure guidelines for pharmaceutical ingredients
Environmental Regulation: Pharmaceutical waste laws require traceable, documentable disposal to deter improper release
