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Product Name: Sitagliptin
Trade Name: Sitagliptin
Synonyms: Sitagliptin phosphate monohydrate
CAS Number: 486460-32-6
Recommended Use: Pharmaceutical intermediate, active ingredient in antidiabetic medication
Manufacturer: Noted on the invoice
Emergency Telephone: Listed on the supplier invoice
Address: Refer to invoice documentation for manufacturer address information
Classification: Specific Target Organ Toxicity (STOT), Eye Irritant, Respiratory Irritant
Signal Word: Warning
Hazard Statements: May cause respiratory irritation, may cause eye irritation, may cause skin irritation, may affect digestive tract if swallowed in large quantities
Pictograms: Exclamation mark, health hazard symbol
Precautionary Statements: Avoid inhalation of dust and vapors, avoid skin and eye contact, wash hands thoroughly after handling, use personal protective equipment as required, do not eat, drink or smoke when handling chemical
Chemical Identity: Sitagliptin phosphate monohydrate
Concentration: 98-100% pure substance
Impurities: Trace organic byproducts from synthesis process; specific impurities and concentrations detailed in certificate of analysis
Molecular Formula: C16H15F6N5O・H3PO4・H2O
Molecular Weight: 523.32 g/mol
Other Ingredients: None known; product supplied as pure compound without excipients
Inhalation: Move person to fresh air immediately, seek medical attention if symptoms such as coughing, breathing difficulties, or throat irritation develop
Skin Contact: Wash affected area thoroughly with soap and water, remove any contaminated clothing, seek medical attention if persistent irritation or rash appears
Eye Contact: Rinse eye slowly and gently with plenty of water for at least 15 minutes, remove contact lenses if present and easy to do, obtain medical care if irritation persists
Ingestion: Rinse mouth with water, do not induce vomiting, seek medical attention immediately
Most Important Symptoms: Irritation of mucous membranes, nausea if ingested, eye redness, skin rash
Suitable Extinguishing Media: Dry chemical, CO2, foam, or water spray
Unsuitable Extinguishing Media: Direct water jet in case of large fires due to potential for contamination
Specific Hazards: Combustion may release toxic fumes including hydrogen fluoride, nitrogen oxides, and carbon oxides
Protective Equipment for Firefighters: Self-contained breathing apparatus and full protective gear
Special Procedures: Avoid inhalation of fire-generated gases, use water spray to cool containers, control run-off to prevent environmental contamination
Personal Precautions: Wear appropriate protective equipment including gloves, eye protection, and lab coat; avoid dust formation
Emergency Procedures: Evacuate unprotected personnel from affected area, ventilate area thoroughly
Environmental Precautions: Prevent entry into drains, sewers, or waterways; notify authorities if large quantities escape
Containment and Cleaning: Moisten spilled material to prevent dust generation, use approved absorbent material, collect in suitable container for safe disposal, decontaminate surfaces with water and detergent
Precautions for Safe Handling: Handle in well-ventilated area, minimize dust generation and accumulation, use personal protective equipment, wash hands after handling, avoid ingestion and direct inhalation
Storage Conditions: Store in tightly-closed original container, keep in a dry, cool, and well-ventilated place away from moisture, strong acids, bases, and oxidizers
Incompatible Materials: Strong acids, strong bases, strong oxidizing agents
Specific End Use: For research, manufacturing, and pharmaceutical use only, not for food, cosmetic, or household use
Control Parameters: No established occupational exposure limits specific to Sitagliptin
Engineering Controls: Work in a chemical fume hood or well-ventilated area; use dust extraction systems if required
Personal Protective Equipment (PPE): Nitrile or latex chemical-resistant gloves, safety goggles, lab coat, suitable respiratory protection if dust is present
Hygiene Measures: Wash hands thoroughly after handling, do not eat, drink, or smoke in areas where material is handled, change contaminated clothing
Appearance: White to off-white crystalline powder
Odor: Odorless or faint chemical odor
Odor Threshold: Not determined
pH: 4.0-6.0 (10 mg/mL aqueous suspension)
Melting Point: 185-190°C
Boiling Point: Not available
Flash Point: Not available
Decomposition Temperature: Decomposes above 190°C
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Negligible at room temperature
Solubility: Freely soluble in water, slightly soluble in ethanol and DMSO
Partition Coefficient (log P): 1.8 (octanol/water)
Vapor Density: Not determined
Relative Density: 1.7 g/cm³
Other Properties: Stable under normal conditions, hygroscopic tendencies noted
Reactivity: Chemically stable under normal temperatures and recommended storage conditions
Chemical Stability: Stable as supplied; avoid excessive moisture and elevated temperatures
Possible Hazardous Reactions: No dangerous reactions known under normal use
Conditions to Avoid: High humidity, temperatures above 40°C, exposure to oxidizing agents
Incompatible Materials: Strong acids, strong bases, oxidizers
Hazardous Decomposition Products: Hydrogen fluoride, nitrogen oxides, carbon monoxide, carbon dioxide on thermal decomposition
Acute Toxicity: LD50 (oral, rat): >2000 mg/kg (low acute toxicity)
Skin Corrosion / Irritation: May cause mild irritation with prolonged contact
Serious Eye Damage / Irritation: May cause eye irritation
Respiratory Sensitization: Possible respiratory tract irritation with dust exposure
Germ Cell Mutagenicity: No evidence of mutagenic risk in standard screening assays
Carcinogenicity: No carcinogenic potential in animal studies
Reproductive Toxicity: No evidence of reproductive toxicity at tested dosages
STOT - Single Exposure: Transient respiratory or digestive irritation possible after substantial exposure
Symptoms / Effects: Coughing, throat irritation, eye redness, stomach discomfort
Other Information: Product intended for controlled medicinal or research settings, accidental environmental or occupational exposure should be minimized
Ecotoxicity: Low risk to aquatic life at predicted environmental concentrations, specific LC50 (fish) >100 mg/L, EC50 (daphnia) >50 mg/L
Persistence and Degradability: May be partially persistent in soil and water; slow degradation reported in environmental simulation studies
Bioaccumulative Potential: Low potential for bioaccumulation (log Kow <2)
Mobility in Soil: Moderate to high; can migrate to groundwater if released in significant quantities
Other Adverse Effects: Not classified as hazardous to ozone layer or as PBT (Persistent, Bioaccumulative, Toxic) or vPvB (very Persistent, very Bioaccumulative)
Waste Treatment Methods: Dispose via licensed chemical waste disposal contractor, according to local, regional, and national regulations
Contaminated Packaging: Rinse thoroughly before recycling or discarding, use suitable destruction method for chemical residues
Incineration: High-temperature incineration preferred method to destroy pharmaceutical compounds
Avoid: Release to sewers, drains, or watercourses; disposal in regular household waste prohibited
Safety Precautions: Wear protective PPE while handling waste, label containers clearly
UN Number: Not classified as dangerous goods under UN transport regulations
UN Proper Shipping Name: Not assigned
Transport Hazard Classes: Not regulated for transport under ADR, IMDG, IATA, DOT
Packing Group: Not applicable
Environmental Hazards: Not considered a marine pollutant
Special Precautions for User: Keep in original container, tightly sealed, protect from damage during transport, avoid moisture contact
Safety, Health, and Environmental Regulations: Subject to pharmaceutical regulations for manufacture, use, and disposal; not specifically listed in U.S. TSCA, Canadian DSL, or EINECS, but covered as active pharmaceutical ingredient
OSHA Status: Considered hazardous chemical according to OSHA Hazard Communication Standard
SARA Title III: Not listed as specifically regulated substance
California Proposition 65: Not listed
REACH Status: Registration as intermediate or active substance might apply in Europe
Other Regulations: Must comply with local, national, and international laws regarding pharmaceuticals and workplace safety
