Sitagliptin Phosphate Monohydrate IP BP EP Ph Eur USP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Sitagliptin Phosphate Monohydrate, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Sitagliptin Phosphate Monohydrate CAS Number 654671-77-9 Monohydrate 654671-78-0 Anhydrous, EINECS EC Number: 682-492-2 Monohydrate 871-227-8 Anhydrous, Molecular Formula: C16H20F6N5O6P or C16H15F6N5O•H3PO4-H2O Monohydrate, Molecular Weight: 523.32 Monohydrate, HS Code 29339900 or 30049099

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SDS MSDS Sheet of Sitagliptin Phosphate Monohydrate Manufacturers

Sitagliptin Phosphate Monohydrate
IP BP EP Ph Eur USP Grade Suppliers
Sitagliptin Phosphate Monohydrate

Sitagliptin Phosphate is the phosphate salt form of sitagliptin, an orally available, competitive, beta-amino acid-derived inhibitor of dipeptidyl peptidase 4 (DDP-4) with hypoglycemic activity. Sitagliptin may cause an increased risk in the development of pancreatitis.

General Properties and Specifications of Sitagliptin Phosphate Monohydrate:
Appearance: White or almost white powder.
Assay: 98% minimum.
Solubility: Soluble in DMSO and in water.
Storage: Refrigerate. OK to freeze. Preserve in a well colsed container.

Sitagliptin Phosphate USP Grade Specifications:
C16H15F6N5O-H3PO4-H2O --- 523.32
C16H15F6N5O-H3PO4 --- 505.31
1,2,4-Triazolo[4,3-a]pyrazine, 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-, phosphate (1:1) monohydrate;
7-[(R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazine monophosphate monohydrate;
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-on phosphate monohydrate CAS 654671-77-9
UNII: TS63EW8X6F
UNII: QFP0P1DV7Z

DEFINITION
Sitagliptin Phosphate contains NLT 98.0% and NMT 102.0% of sitagliptin phosphate (C16H15F6N5O-H3PO4), calculated on the anhydrous and solvent-free basis.

IDENTIFICATION
A. Infrared Absorption
B. Meets the requirements of the test for Enantiomeric Purity.
C. Identification Tests—General, Phosphate: A solution containing about 40 mg/mL in water meets the requirements of the silver nitrate precipitation tests for orthophosphates.
Organic Impurities: to pass the test by Chromatography.
Water Determination: 3.3%–3.7%


Sitagliptin Phosphate Monohydrate BP Ph Eur Grade Specifications:
C16H18F6N5O5P,H2O --- 523.3 CASC654671-77-9
Action and use: Dipeptidylpeptidase-4 inhibitor; treatment of diabetes mellitus.

DEFINITION
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Soluble in water, very slightly soluble in anhydrous ethanol, practically insoluble in heptane.
It shows polymorphism.

IDENTIFICATION
A
. Infrared absorption spectrophotometry.
B. Enantiomeric purity.
C. Dissolve 0.200 g in water and dilute to 5.0 mL with the same solvent. The solution gives reaction (a) of phosphates.

TESTS
Enantiomeric purity: To pass the test by Liquid chromatography.
Related substances: To pass the test by Liquid chromatography.
Water: 3.3 per cent to 3.7 per cent, determined on 0.300 g.
Sulfated ash: Maximum 0.2 per cent, determined on 1.0 g in a platinum crucible.

For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

We also manufacture and supply as under:

Biotin

Calcium Phosphate

Niacin or Nicotinic Acid

Pectin

Potassium Phosphate

Triacetin

Vildagliptin.

Sitagliptin

Sitagliptin HCl or Sitagliptin Hydrochloride or Sitagliptin Monohydrochloride

Sitagliptin Phosphate Monohydrate.

Manufacturers:

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30

e-mail: info@mubychem.com

USA, Canada, Mexico and other American
neighbouring buyers may
e-mail: us@mubychem.com
Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)

Manufacturers india
Copyright and Usual Disclaimer is Applicable.
Last 14 May, 2024

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Sitagliptin Phosphate Monohydrate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet
09-Feb-24

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
Molecular Formula: C16H20F6N5O6P or C16H15F6N5O•H3PO4-H2O Monohydrate
Molecular Weight: 523.32 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

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
Irritant

GHS Label Elements
healthhazard.png
Health Hazard

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.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
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.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xi Irritant
Risk Phrase:
R36 Irritating to eyes.
R48 Danger of serious damage to health by prolonged exposure.

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. Wash clothing and shoes before reuse.
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 spread 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. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

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.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
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. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

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. 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.). Prevent any contact with hot surfaces.
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 contact with skin and eyes. 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. Local exhaust ventilation is preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area. Please refer to the ACGIH document, Industrial Ventilation, A Manual of Recommended Practices, most recent edition, for details.
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. If oil particles (e.g., lubricants, cutting fluids, glycerin, etc.) are present, use a NIOSH type R or P filter. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator. WARNING: Air-purifying respirators do not protect workers in oxygen-deficient atmospheres.
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. Wash hands after handling.

9. Physical and Chemical Properties

Appearance: White or almost white powder.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting point/freezing point: Not available.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Soluble in DMSO and in water.
Viscosity: Not available.
Molecular Formula: C16H20F6N5O6P or C16H15F6N5O•H3PO4-H2O Monohydrate
Molecular Weight: 523.32 Monohydrate.

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 data available.
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 data available.
Reproductive toxicity: no data available.
Causes damage to organs through prolonged or repeated exposure.

12. Ecological Information

Toxicity to fish: No information available.
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

13. Disposal Considerations

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of containers and unused material in accordance with legal requirements.

14. Transport Information

DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IMDG/IMO: Not regulated.
IATA: Not regulated.

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 as listed under Proposition 65 State Drinking Water and Toxic Enforcement Act.

Section 16 - Additional Information

European Labeling in Accordance with EC Directives:
H319: Causes serious eye irritation.
H373: Causes damage to organs through prolonged or repeated exposure.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xi Irritant
Risk Phrase:
R36 Irritating to eyes.
R48 Danger of serious damage to health by prolonged exposure.

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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