American Molecules - Ammol.org USA

Sitagliptin Hydrochloride or Sitagliptin HCl SDS Safety Data Sheet of Supplier Exporter Manufacturers' Representative

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Sitagliptin Hydrochloride or Sitagliptin HCl
CAS Number: 486459-71-6 or 862156-92-1 for monohydrate

Molecular Formula: C16H16ClF6N5O
Molecular Weight: 443.77 or 461.79 for monohydrate

Sitagliptin Hydrochloride or Sitagliptin HCl Suppliers
Sitagliptin Hydrochloride or Sitagliptin HCl

Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride
SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet
 01-Feb-25

1. Product Identification

Product Name & Other Names: Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride.
CAS No.: 486459-71-6 or 862156-92-1 for monohydrate
EINECS EC Number: 813-550-9 or 815-123-2 for monohydrate
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

2. Hazards Identification

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Acute toxicity, oral Category 4, H302
Skin corrosion/irritation Category 2, H315
Serious eye damage/eye irritation Category 2A, H319
Specific target organ toxicity, single exposure; Respiratory tract irritation Category 3, H335

Labeling according to Regulation (EC) No 1272/2008

GHS Label Elements
Irritant
Irritant

Signal Words: Warning

Hazard statements:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.

Precautionary statements:
P262: Do not get in eyes, on skin, or on clothing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P270: Do not eat, drink or smoke when using this product.
P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P332+313: If skin irritation occurs: Get medical advice/attention.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P332+313: If skin irritation occurs: Get medical advice/attention.
P337+P313 If eye irritation persists: Get medical advice/ attention.

3. Composition/Information on Ingredients

Product Name & Other Names:Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride.
CAS No.: 486459-71-6 or 862156-92-1 for monohydrate
EINECS EC Number: 813-550-9 or 815-123-2 for monohydrate.

4. First Aid Measures

Inhalation:Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Keep person warm and quiet; get medical attention.
Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person.
Skin Contact: Immediately flush skin with plenty of soap and water for at least 15 minutes. Remove contaminated clothing and shoes. Wash clothing before reuse. Get medical attention if irritation develops.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention.

5. Fire Fighting Measures

Fire: May become a fire hazard at high temperatures.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Avoid solid water jet as it may scatter the fire.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Fluorine compounds, Hydrogen chloride gas, Fumes.
Special Information In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode.

6. Accidental Release Measures

Personal precautions, protective equipment, and emergency procedures: Use personal protective equipment. Avoid dust formation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container.

7. Handling and Storage

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Avoid dust formation and control ignition sources. Containers may be hazardous when empty. Storage: Refrigerate. OK to freeze. Short term shipping may be at room temperature.

8. Exposure Controls/Personal Protection

Airborne Exposure Limits: Contains no substances with occupational exposure limit values.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice.

9. Physical and Chemical Properties

Appearance: No information found.
Odor: No information found.
Odor threshold: No information found.
pH: No information found.
Relative density: No information found.
Boiling Point: No information found.
Melting Point: No information found.
Flash point
: No information found.
Auto-ignition temperature: No information found.
Decomposition temperature: No information found.
Upper/lower flammability or explosive limits: No information found.
Vapor pressure: No information found.
Vapor density: No information found.
Evaporation rate: No information found.
Flammability (solid, gas): No information found.
Partition coefficient: n-octanol/water: No information found.
Solubility: No information found.
Viscosity: No information found.

10. Stability and Reactivity

Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Nitrogen oxides, Fluorine compounds, and carbon oxides along with chlorine compounds and fumes.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, flame, ignition sources, dusting, and incompatibles.

11. Toxicological Information

LD50 Oral - Rat - No information found.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: No information found.
Developmental Toxicity: No information found.
Reproductive Effects: No information found.

12. Ecological Information

Persistence and Degradability: No information found.
Persistence and Degradability: No information found.
Mobility: No information found.
Bioaccumulation/ Accumulation: No information found.
Results of PBT and vPvB assessment: No information found for assessment.

13. Disposal Considerations

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Follow all the pollution control rules

14. Transport Information

DOT USA, TDG and ADR/RID Europe: Not dangerous goods.
IATA and IMDG/IMO: Not dangerous goods.

15. Regulatory Information

USA:
SARA 311/312 Hazardous Categorization
: No SARA hazards.
California Proposition 65: Not listed.

16. Other Information

Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.

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Suppliers and Manufacturers' Representative:
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Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
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19 April, 2025