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Product Name: Orlistat
Chemical Name: Tetrahydrolipstatin
Other Names: Xenical, Alli
CAS Number: 96829-58-2
Recommended Use: Pharmaceutical product for the treatment of obesity
Manufacturer’s Details: Contact information for the pharmaceutical manufacturer including address, phone number, and emergency contact
Relevant Identified Uses: Treatment of overweight conditions, chronic weight management
Restrictions on Use: Not recommended for children under 12, pregnant or breastfeeding women unless prescribed by a physician
Classification: Not classified as hazardous under GHS guidelines for normal handling, but caution advised due to pharmaceutical nature
Label Elements: None required for general use in medicine, but precaution labels recommended during bulk handling
Key Hazards: Dust inhalation can cause respiratory irritation, ingestion may lead to gastrointestinal effects, skin contact may cause irritation in sensitive individuals
Health Effects: Overexposure can result in oily stools, abdominal pain, fecal urgency, potential liver enzyme elevation in rare cases
Environmental Hazards: No major hazard in standard quantities, caution with large spills to prevent entry into waterways
Chemical Composition: Orlistat 120 mg per capsule (varies by product)
Ingredient Purity: Typically above 98% for active pharmaceutical ingredient
Additional Components: Microcrystalline cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, purified talc, gelatin capsule
Impurities: Trace amounts, typically below 0.10% of related impurities; detailed batch reporting by manufacturer
Inhalation: Move to fresh air, monitor for respiratory distress, seek medical attention if symptoms develop
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, consult healthcare if irritation persists
Eye Contact: Flush immediately with plenty of water for a minimum of 15 minutes, consult healthcare if discomfort continues
Ingestion: Rinse mouth out with water, provide symptomatic care, consult emergency medical support if significant quantities ingested
Medical Treatment: Treat symptomatically and supportively, monitor for gastrointestinal effects, liver function monitoring if large amounts consumed
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, or water spray
Unsuitable Extinguishing Media: Direct water jets for large fires can spread material
Fire/Explosion Hazards: Dust formation presents risk of combustion in confined spaces, decomposition products include oxides of carbon and nitrogen
Protective Equipment: Firefighters should use self-contained breathing apparatus with full protective gear, control run-off to prevent environmental spread
Special Precautions: Move material from fire area if safe, cool containers exposed to flames, avoid inhalation of combustion fumes
Personal Precautions: Wear gloves, safety glasses, and dust mask to prevent exposure; avoid contact with skin, eyes, and inhalation
Spill Response: Use non-combustible absorbent material (sand, earth); sweep up and collect for proper disposal; prevent spread of dust
Environmental Measures: Prevent entry into drains, surface water, or soil; notify authorities in case of significant release
Clean-up Methods: Collect and dispose of in accordance with local regulations; disinfect area with water and detergent after removal
Safe Handling: Avoid creating dust, handle in well-ventilated zone, use protective equipment
Hygiene Measures: Do not eat, drink, or smoke while handling; wash hands after use
Storage Conditions: Store tightly closed in original container in a dry, cool, well-ventilated area; avoid heat, light, and moisture exposure
Incompatible Materials: Oxidizers, acids, bases
Storage Life: Typically 2 to 3 years under recommended conditions
Packaging Materials: Use original, sealed packaging where possible
Engineering Controls: Local exhaust ventilation, process enclosure, dust extraction systems as necessary
Personal Protective Equipment: Safety glasses with side shields, laboratory gloves (nitrile preferred), lab coat
Respiratory Protection: Dust mask recommended for bulk handling or during cleaning operations
Biological Monitoring: Recommended for workers involved in prolonged handling; liver function and respiratory checks
Exposure Limits: No established occupational exposure limit for orlistat, minimize exposure as a precaution
Appearance: White to off-white crystalline powder (pure substance); may be encapsulated in gelatin capsules
Odor: Nearly odorless
pH: Not applicable (non-aqueous substance)
Melting Point: 42–46°C
Boiling Point: Not available (decomposes before boiling)
Flash Point: Data unavailable, not highly flammable
Solubility: Practically insoluble in water; slightly soluble in ethanol, methanol
Vapor Pressure: Negligible at room temperature
Density: Approximately 1.2 g/cm³
Partition Coefficient (log Kow): 7.6
Stability: Stable under recommended storage conditions
Chemical Stability: Stable under normal temperatures and pressures; sensitive to strong acids, bases, and oxidizers
Conditions to Avoid: Heat, light, moisture, incompatible substances
Reactive Substances: Avoid oxidizing agents, strong acids/bases
Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, other unidentified toxic fumes under fire conditions
Hazardous Reactions: None reported under normal pharmaceutical use
Acute Toxicity: Oral LD50 in rats: > 5,000 mg/kg (low acute toxicity in animal models)
Chronic Exposure: Long-term use can result in fat-soluble vitamin deficiencies, rare liver injury, kidney stone risk
Health Effects: Mainly gastrointestinal (steatorrhea, fecal urgency, abdominal pain), isolated cases of severe liver injury, kidney stones, allergic skin reactions
Sensitization: No significant reports of respiratory or skin sensitization
Carcinogenicity: Negative in animal studies, not listed as carcinogen by NTP, IARC, or OSHA
Mutagenicity: Negative in standard in vitro and in vivo genetic toxicity assays
Aquatic Toxicity: No significant acute aquatic toxicity at expected environmental concentrations; full ecotoxicological data limited
Persistence and Degradability: Poorly biodegradable; persistence in sediment possible
Bioaccumulation: High octanol-water partition coefficient suggests bioaccumulation potential in aquatic organisms
Mobility in Soil: Low mobility, likely to adsorb to soil particles
Other Ecological Effects: Unlikely to cause environmental harm in pharmaceutical quantities; avoid release of large amounts into waterways
Waste Treatment Methods: Incinerate in approved facility or land disposal in accordance with local regulations
Packaging Disposal: Empty containers should be triple-rinsed and disposed of according to hazardous waste procedures
Hazardous Waste Number: Not regulated as hazardous waste under federal systems, classification may differ by region
Recommendation: Return unused drug or bulk material to authorized collection points for safe disposal
UN Number: Not regulated for transport
Shipping Name: Not hazardous under transport regulations
Transport Hazard Class: Not classified
Packing Group: None
Special Precautions: Protect from heat, direct sun, humidity; follow pharmaceutical cold chain guidance if required
Packaging Instructions: Keep in tightly closed, labelled containers; use secondary containment for bulk shipments
Regulatory Status: Prescription pharmaceutical in most countries, subject to FDA, EMA, TGA, and local medicines agency controls
Safety Assessment: Evaluated by national drug agencies; subject to regular reappraisal and post-marketing safety surveillance
OSHA: Not regulated as hazardous under US OSHA standards
WHMIS (Canada): Exempt as a finished pharmaceutical product
REACH (EU): Registration not required for finished pharmaceuticals
TSCA (US): Exempt from inventory under Section 3(2)(B)(vi) for drugs
Other: Not subject to major chemical accident hazard regulations; user organizations should comply with workplace safety, environmental, and drug control rules
