🛡️ Hazard Overview
- GHS Class: GHS05; GHS07; GHS08
- Signal Word: Danger
- Hazard Statements: H302; H318; H373
🧤 PPE Guidelines
- Gloves: Chemical‑resistant gloves suggested
- Eye Protection: Safety goggles suggested
- Respirator: Dust respirator if dust occurs
❄️ Storage
- Storage Temp: -20°C (-4°F) Keep dry
🚑 Emergency First Aid
- For inhalation, skin, eye or ingestion exposure, please refer to full SDS Section 4.
Product identifier
- Product Name: Sitagliptin
- Catalog Number: S5079
- CAS Number: 486460-32-6
- IUPAC Name: 1-Butanone, 3-amino-1-[5,6-dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)-, (3R)-
Relevant identified uses and uses advised against
- Identified uses: For research and development use only; laboratory chemicals; manufacture of substances.
- Uses advised against: Not for pharmaceutical, household, or other unapproved uses.
Details of the supplier
- Company: Selleck Chemicals
- TollFree: +1 877 796-6397
- Tel: +1 832 582-8158
- Fax: +1 832 582-8590
Emergency telephone number
- Emergency phone #: +1 832 582-8158
2.1 GHS classification in accordance with 29 CFR 1910 (OSHA HCS):
Acute toxicity (oral): Category 4. H302
Serious eye damage: Category 1. H318
Specific target organ toxicity (repeated exposure): Category 2. H373
2.2 GHS Label elements, including precautionary statements
Hazard Pictogram(s):
Signal Word:
Danger
Hazard statement(s):
H302: Harmful if swallowed
H318: Causes serious eye damage
H373: May causes damage to organs through prolonged or repeated exposure
Precautionary statement(s):
Prevention:
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P264: Wash hands thoroughly after handling.
P264+P265: Wash hands thoroughly after handling. Do not touch eyes.
P270: Do not eat, drink or smoke when using this product.
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.
Response:
P301+P317: IF SWALLOWED: Get medical help.
P305+P354: IF IN EYES: Immediately rinse with water for several minutes.
P317: Get emergency medical help.
P319: Get medical help if you feel unwell.
P330: Rinse mouth.
P338: Remove contact lenses, if present and easy to do. Continue rinsing.
Disposal:
P501: P501 Dispose of contents/ container to an approved waste disposal plant.
2.3 Other hazards
None.
3.1 Substances
Product name: Sitagliptin
CAS Number: 486460-32-6
PubChem CID: 4369359
Molecular formula: C16H15F6N5O
Molecular weight: 407.31 g/mol
IUPAC name: (3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one
3.2 Mixtures
Not applicable (pure substance).
4.1 Description of first aid measures
Inhalation: Move to fresh air. Keep at rest in a position comfortable for breathing. Seek medical attention if symptoms persist.
Skin contact: Wash with plenty of soap and water. Remove contaminated clothing. Seek medical attention if irritation develops.
Eye contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Seek medical attention.
Ingestion: Rinse mouth. Do NOT induce vomiting unless directed by medical personnel. Seek medical attention.
4.2 Most important symptoms and effects, both acute and delayed
See Section 11 (Toxicological Information).
4.3 Indication of any immediate medical attention and special treatment needed
Treat symptomatically. Contact a poison control center or physician for severe exposure.
5.1 Extinguishing media
Suitable: Water spray, dry chemical, carbon dioxide (CO2), alcohol-resistant foam.
Unsuitable: None known.
5.2 Specific hazards arising from the substance or mixture
Suitable extinguishing agents: water spray, carbon dioxide, dry chemical powder or foam. Protective equipment: wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. /Sitagliptin phosphate monohydrate/
5.3 Advice for firefighters
Wear self-contained breathing apparatus (SCBA) and full protective clothing.
Fight fire from upwind. Cool containers with water spray until fire is extinguished.
6.1 Personal precautions, protective equipment and emergency procedures
Wear appropriate personal protective equipment (see Section 8).
Avoid breathing dust/vapor. Ensure adequate ventilation.
Evacuate personnel to safe areas. Keep people away from and upwind of spill.
6.2 Environmental precautions
Prevent product from entering drains, waterways, or soil.
Contain spill with inert absorbent material.
6.3 Methods and materials for containment and cleaning up
Accidental release measures: After Inhalation: cordon off area of spill; wear self-contained breathing apparatus, protective clothing and heavy rubber gloves Measures for cleaning/collecting absorb solutions with finely-powdered liquid-binding material (diatomite, universal binders); decontaminate surfaces and equipment by scrubbing with alcohol; dispose of contaminated material /in accordance with prevailing country, fedreal, state and local regulations/. /Sitagliptin phosphate monohydrate/
SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.
Handling should only be performed by personnel trained and familiar with handling of potent active pharmaceutical ingredients. /Sitagliptin phosphate monohydrate/
Information for safe handling: avoid inhalation and contact with skin, eyes and clothing ... . /Sitagliptin phosphate monohydrate/
7.1 Precautions for safe handling
Store at 20-25 °C (68-77 °F), excursions permitted to 15-30 °C (59-86 °F).
7.2 Conditions for safe storage, including any incompatibilities
Store at 20-25 °C (68-77 °F), excursions permitted to 15-30 °C (59-86 °F).
Store away from incompatible materials (see Section 10).
[Note: Specific storage temperature not available in public databases. Refer to supplier Certificate of Analysis (COA) for exact storage conditions.]
8.1 Exposure controls
8.1.1 Occupational exposure limits (OEL)
OSHA PEL: Not established.
ACGIH TLV: Not established.
NIOSH REL: Not established.
No occupational exposure limit values are established for this substance.
Use the lowest feasible exposure level (ALARA principle).
8.1.2 Appropriate engineering controls
Use in a well-ventilated area. Chemical fume hood recommended for powder handling.
8.2 Individual protection measures
8.2.1 Eye/face protection
Wear chemical safety goggles and face shield.
8.2.2 Skin protection
Wear protective gloves. Recommended material: Nitrile rubber.
Wear suitable protective clothing (lab coat).
8.2.3 Respiratory protection
Respiratory protection usually not required under normal use with adequate ventilation.
Use N95 respirator for large-scale powder handling.
8.2.4 Thermal hazards
Not applicable.
9.1 Information on basic physical and chemical properties
a) Appearance: Solid
b) Odor: No data available
c) Odor threshold: No data available
d) pH: No data available
e) Melting point/freezing point: No data available
f) Initial boiling point and boiling range: No data available
g) Flash point: No data available
h) Evaporation rate: No data available
i) Flammability (solid, gas): No data available
j) Upper/lower flammability or explosive limits: No data available
k) Vapor pressure: No data available
l) Vapor density: No data available
m) Relative density: No data available
n) Water solubility: 3.40e-02 g/L
o) Partition coefficient: n-octanol/water: Log P (n-octanol/water): 0.7
p) Auto-ignition temperature: No data available
q) Decomposition temperature: No data available
r) Viscosity: No data available
s) Explosive properties: No data available
t) Oxidizing properties: No data available
9.2 Other information
Topological Polar Surface Area (TPSA): 77 Ų
Complexity: 566
10.1 Reactivity
No specific reactivity hazards identified under normal handling conditions.
10.2 Chemical stability
Stable under recommended storage conditions.
10.3 Possibility of hazardous reactions
No hazardous reactions under normal conditions.
10.4 Conditions to avoid
Avoid heat, sparks, open flames, direct sunlight, and moisture.
Avoid strong oxidizing agents, strong acids, and strong bases.
10.5 Incompatible materials
Strong oxidizing agents, strong acids, strong bases.
10.6 Hazardous decomposition products
Thermal decomposition may produce: Carbon monoxide (CO), Carbon dioxide (CO₂), Nitrogen oxides (NOx), Hydrogen fluoride (HF).
See also Section 5 (Fire-fighting measures) for combustion products.
11.1 Information on toxicological effects
Acute toxicity:
No acute toxicity data available.
Skin corrosion/irritation:
No data available.
Serious eye damage/eye irritation:
Causes serious eye damage (H318).
Respiratory or skin sensitization:
No data available.
Germ cell mutagenicity:
No data available.
Carcinogenicity:
No data available.
Reproductive toxicity:
No data available.
Specific target organ toxicity (single exposure):
H373
Specific target organ toxicity (repeated exposure):
No data available.
Aspiration hazard:
No data available.
11.2 Additional information
No additional toxicological information available.
12.1 Toxicity
Sitagliptin's production and use as an antidiabetic drug may result in its release to the environment through various waste streams. If released to air, an estimated vapor pressure of 2.9X10-8 mm Hg at 25 °C indicates sitagliptin will exist in both the vapor and particulate phases in the atmosphere. Vapor-phase sitagliptin will be degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals; the half-life for this reaction in air is estimated to be 4 hours. Particulate-phase sitagliptin will be removed from the atmosphere by wet and dry deposition. Sitagliptin contains chromophores that absorb at wavelengths >290 nm and, therefore, may be susceptible to direct photolysis by sunlight. If released to soil, sitagliptin is expected to have no mobility based upon an estimated Koc of 3.4X10+4. The estimated pKa of sitagliptin is 8.78, indicating that this compound will exist partially in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts. Volatilization of the neutral species from moist soil surfaces is not expected to be an important fate process based upon an estimated Henry's Law constant of 2.6X10-15 atm-cu m/mole. Sitagliptin is not expected to volatilize from dry soil surfaces based upon its vapor pressure. Biodegradation data in soil or water were not available. If released into water, sitagliptin is expected to adsorb to suspended solids and sedim
12.2 Persistence and degradability
No data available.
12.3 Bioaccumulative potential
Log P (n-octanol/water): 0.7
Low potential for bioaccumulation (Log P < 3).
12.4 Mobility in soil
No data available.
12.5 Results of PBT and vPvB assessment
PBT/vPvB assessment not available.
12.6 Other adverse effects
No other adverse ecological effects identified.
13.1 Waste treatment methods
Waste Treatment Methods: Waste material must be disposed of in accordance with national and local regulations. Leave chemicals in original containers and do not mix with other waste. Handle uncleaned containers in the same manner as the product itself.
14.1 UN number
Not regulated as dangerous goods (research quantities typically exempt).
14.2 UN proper shipping name
Not subject to transport regulations (small quantities for research use).
14.3 Transport hazard class(es)
Not classified as dangerous goods for transport (research quantities).
14.4 Packing group
Not applicable (not regulated as dangerous goods in typical research quantities).
14.5 Environmental hazards
Marine pollutant: No (not classified as environmentally hazardous per GHS).
14.6 Special precautions for user
Transport in original packaging. Ensure containers are tightly sealed.
For bulk or commercial quantities, consult applicable transport regulations (DOT, IATA, IMDG).
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not applicable.
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
US EPA / TSCA: Not available in public databases.
EU ECHA / REACH: Registered (REACH Active)
SARA 302 Components:
No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components:
This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards:
Acute (short-term) health hazard
Chronic (long-term) health hazard
Massachusetts Right To Know Components:
This material contains components subject to the Massachusetts Right to Know Act. See Section 2 for hazard classification.
Pennsylvania Right To Know Components:
This material contains components subject to the Pennsylvania Right to Know Act. See Section 2 for hazard classification.
New Jersey Right To Know Components:
This material contains components subject to the New Jersey Right to Know Act. See Section 2 for hazard classification.
California Prop. 65 Components:
This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.
Other regulatory listings:
- FDA Requirements: The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, incl sitagliptin phosphate, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Sitagliptin phosphate/
15.2 Chemical safety assessment
A chemical safety assessment has not been carried out for this substance.
For research-use-only compounds, no CSA is required under REACH Annex I.
Revision Date: 2026/09/09
Further Information: The information provided is believed to be correct but is not exhaustive and should be used only as a guideline based on current knowledge. It does not represent a guarantee of the properties of the product. Selleck Chemicals Corporation and its Affiliates shall not be held liable for any damage resulting from handling or contact with the product.