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Sitagliptin Phosphate Monohydrate Anhydrous SDS Safety Data Sheet of Supplier Exporter Manufacturers' Representative |
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Sitagliptin Phosphate Monohydrate Anhydrous
CAS Number: 654671-77-9 Monohydrate 654671-78-0 Anhydrous
Molecular Formula: C16H20F6N5O6P or C16H15F6N5O•H3PO4-H2O Monohydrate
Molecular Weight: 523.32 Monohydrate
Sitagliptin Phosphate Monohydrate Anhydrous
Sitagliptin Phosphate Monohydrate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 01-Feb-25
1. Product Identification
Product Name & Other Names: Sitagliptin Phosphate Monohydrate.
CAS No.: 682-492-2 Monohydrate 871-227-8 Anhydrous
EINECS EC Number: 690-730-1
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
Serious eye damage/eye irritation Category 2A, H319
Specific target organ toxicity, repeated exposure Category 2, H373
Labeling according to Regulation (EC) No 1272/2008
GHS Label Elements  Irritant |
GHS Label Elements |
Signal Words: Warning
Hazard statements:
H319: Causes serious eye irritation.
H373: Causes damage to organs through prolonged or repeated exposure.
Precautionary statements:
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P264: Wash … thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/ attention.
3. Composition/Information on Ingredients
Product Name & Other Names: Sitagliptin Phosphate Monohydrate.
CAS No.: 682-492-2 Monohydrate 871-227-8 Anhydrous
EINECS EC Number: 690-730-1
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen and get medical attention immediately.
Ingestion: Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Get medical attention.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.
5. Fire Fighting Measures
Fire: Not a fire hazard. However, it can burn at high temperatures.
Fire Extinguishing Media: Water spray, dry chemical, alcohol foam, or carbon dioxide. Avoid solid water jet as it can scatter the fire.
Hazardous decomposition products formed under fire conditions: Oxide of nitrogen, oxides of carbon, fluorine compounds, phosphorous compounds, and fumes are expected to form.
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: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. 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. 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. Storage: Refrigerate. OK to freeze. Preserve in a well closed container.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: This product, as supplied, does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
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 (NIOSH type N95 or better filters) may be worn.
Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron, or coveralls, as appropriate, to prevent skin contact.
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: White or almost white powder.
Odor: No information found.
Odor threshold: No information found.
pH: No information found.
Relative density: No information found.
Melting point/freezing point: No information found.
Initial boiling point and boiling range: 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: Soluble in DMSO and in water.
Viscosity: No information found.
10. Stability and Reactivity
Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Oxide of nitrogen, oxides of carbon, fluorine compounds, phosphorous compounds, and fumes are expected to form.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Avoid incompatibilities, heat, flames, sparks, and other sources of ignition.
11. Toxicological Information
LD50 oral rat: No information found.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible, or confirmed human carcinogen by IARC.
Teratogenicity: No information found.
Reproductive toxicity: No information found.
Causes damage to organs through prolonged or repeated exposure.
12. Ecological Information
Toxicity to fish: 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 Canada & ADR/RID Europe: Not dangerous goods.
IMDG/IMO: Not dangerous goods.
IATA: Not dangerous goods.
15. Regulatory Information
USA:
California Prop. 65 Components: This product contains a chemical known to the State of California to cause cancer, and/or birth defects, and/or other reproductive harm.
Section 16 - Additional 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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Houston, TX 77040, USA
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