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Material Safety Data Sheet (MSDS) for Olanzapine

Identification

Product Name: Olanzapine
Chemical Name: 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine
CAS Number: 132539-06-1
Recommended Use: Pharmaceutical manufacturing and research
Manufacturer Details: Refer to supplier documentation or licensed pharmaceutical vendors
Emergency Phone: National Poison Control Center: 1-800-222-1222
Synonyms: Zyprexa, Olanzapin, 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine

Hazard Identification

GHS Classification: Not classed as hazardous for supply or transport under current regulations
Acute Health Hazards: Risk of mild central nervous system depression, risk increases with accidental ingestion, potential for drowsiness, dizziness, hypotension
Chronic Health Hazards: Possible liver effects, metabolic changes such as weight gain or high blood sugar
Routes of Exposure: Inhalation during handling as dust, ingestion, eye and skin contact
Physical Hazards: Not combustible in standard settings, may generate irritating fumes at high temperatures
Environmental Hazards: Rub off into groundwater only if released in bulk; otherwise, low risk in standard medical environments

Composition / Information on Ingredients

Chemical: Olanzapine
Purity: ≥98% (pharmaceutical grade)
Formula: C17H20N4S
Molecular Weight: 312.44 g/mol
Impurities: Trace synthesis byproducts (listed on Certificate of Analysis from supplier), carriers in finished dosages might include lactose monohydrate, microcrystalline cellulose, magnesium stearate depending on manufacturer

First Aid Measures

Inhalation: Move to fresh air, support breathing as needed, seek medical attention for persistent symptoms
Ingestion: Rinse mouth, drink water, never induce vomiting for unconscious person, call physician or poison control
Eye Contact: Flush eyes with plenty of water for at least 15 minutes, keep eyelids apart, seek immediate medical care
Skin Contact: Remove contaminated clothing, wash affected area with soap and water, seek medical advice for irritation or exposure concerns
Note to Physician: Treat symptomatically, monitor vital signs closely due to risk of hypotension or CNS depression

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, foam
Unsuitable Media: Strong direct water jet on burning powder
Specific Hazards: Emits toxic fumes including carbon monoxide, sulfur oxides, nitrogen oxides during combustion
Protective Equipment: Full protective gear, self-contained breathing apparatus to avoid inhalation of combustion products
Firefighting Actions: Keep containers cool by spraying with water, clear area of unprotected personnel, avoid water runoff contamination

Accidental Release Measures

Personal Precautions: Use personal protective equipment like gloves, lab coats, safety glasses, avoid dust formation and inhalation
Environmental Precautions: Prevent from entering drains or water sources, notify authorities if massive spills reach surface water
Containment Methods: Scoop up spilled product with damp cloth or absorbent, avoid creating airborne particles, ventilate area
Clean-Up Procedures: Dispose in designated pharmaceutical waste containers, wash area with soap and water, follow workplace safety procedures

Handling and Storage

Handling: Handle in well-ventilated area, avoid breathing dust or vapor, use appropriate PPE, wash hands thoroughly after use
Storage Conditions: Store in tightly sealed containers, keep at temperature specified by supplier (typically controlled room temperature, 20-25°C), shelter from moisture and light
Incompatible Materials: Strong oxidizing agents, acids, bases
Safe Transfer: Use tools designed for powders, avoid contamination with other chemicals, label containers clearly

Exposure Controls and Personal Protection

Engineering Controls: Local exhaust recommended, work with closed systems or in designated powder handling cabinets for bulk or powdered forms
Personal Protection: Laboratory gloves (nitrile or latex), protective goggles, lab coat, in high-exposure environments use respirator fitted to local requirements
Hygiene Measures: Regular hand washing, remove contaminated clothing, no eating or drinking in work area
Exposure Limits: No occupational exposure limits established for Olanzapine, minimize exposure levels as a precaution

Physical and Chemical Properties

Appearance: Light yellow crystalline powder
Odor: Odorless or nearly odorless
pH: Not applicable (insoluble in water at neutral pH)
Melting Point: 195–197°C
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Slightly soluble in water, more soluble in nonpolar organic solvents (chlorinated solvents, methanol, DMSO)
Partition Coefficient (logP): Approximately 2.7
Vapor Pressure: Negligible at ambient temperature
Flash Point: Not readily flammable
Density: Approximately 1.3 g/cm³
Stability: Stable under recommended storage, light sensitive

Stability and Reactivity

Chemical Stability: Stable under standard conditions if kept sealed
Potentially Hazardous Reactions: Strong oxidizers may react violently
Conditions to Avoid: Excess heat, open flames, exposure to strong UV or visible light, prolonged exposure to air
Hazardous Decomposition Products: May liberate nitrogen oxides, sulfur oxides, carbon monoxide, irritating organic compounds during fire or excessive heat

Toxicological Information

Acute Toxicity: Limited data for direct human exposure, animal studies show low acute toxicity (LD50 oral, rat: > 500 mg/kg)
Chronic Toxicity: Risk of metabolic effects, weight gain, hyperglycemia, possible hepatotoxicity with chronic exposure
Routes of Exposure: Occupational exposure mainly by skin contact, accidental inhalation of powder; ingestion in non-patient settings rare
Irritation: Slight irritant to respiratory tract, may cause mild skin or eye irritation on contact
Sensitization: No strong evidence of sensitization in clinical or bulk handling settings
Reproductive Toxicity: Animal data show developmental toxicity at high doses; use in pregnancy only if clearly needed under medical supervision
Carcinogenicity: Not listed as a carcinogen by IARC, NTP, or OSHA
Mutagenicity: No significant mutagenic effects found in standard screening assays
Additional Information: Monitor for drowsiness, hypotension, or anticholinergic effects if significant exposure occurs

Ecological Information

Aquatic Toxicity: Low expected in typical medical settings, limited mobility in soils
Persistence and Degradability: Degrades slowly in environment, typically breaks down by photolysis and microbial action
Bioaccumulative Potential: Low-moderate, environmental monitoring does not show significant accumulation at scale
Mobility in Soil: Low, tightly bound to particulate matter
Other Adverse Effects: Not expected to be hazardous to aquatic life at trace concentrations, large-scale industrial spills need evaluation

Disposal Considerations

Waste Disposal Methods: Dispose via licensed pharmaceutical or hazardous waste contractor; do not release to sewer systems
Contaminated Packaging: Clean and reuse or destroy via approved means, label as hazardous if residues remain
Special Precautions: Adhere to local, state, federal disposal regulations; incineration preferred where facilities exist

Transport Information

UN Number: Not regulated as dangerous good
Proper Shipping Name: Olanzapine or pharmaceutical product
Transport Hazard Class: Non-hazardous under most transport regulations (ADR/RID, IATA, IMDG)
Packing Group: Not applicable
Special Precautions: Keep product in secure, labeled containers, avoid spillage during transfer or shipping

Regulatory Information

US Regulations: Not classed as hazardous substance by OSHA, not listed on SARA Title III, CERCLA, or RCRA lists; prescription status regulated by FDA
EU Regulations: Not classified as hazardous under EC 1272/2008 (CLP/GHS), subject to regulations around pharmaceutical product handling
Other Regulations: Commercial use limited to licensed facilities and prescribed patients, disposal rules may differ by region; review local listing for scheduling, waste, and worker protection standards