Sitagliptin Phosphate (Monohydrate/Hydrochloride) API

Name of Product Sitagliptin Phosphate Monohydrate/Hydrochloride
CAS No 654671-77-9/486459-71-6
Therapeutic use:- DPP‑4 inhibitor – oral antidiabetic
Grade IH
Form:- API Powder
Status Commercial
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Product Overview

Sitagliptin Phosphate Monohydrate, or Sitagliptin Hydrochloride, is a DPP-4 enzyme inhibitor used for the treatment of Type 2 Diabetes Mellitus (T2DM).

It helps person with Type 2 Diabetes Mellitus (T2DM) in controlling their blood sugar better.

Sitagliptin functions by preventing DPP-4.

This helps the body’s incretin system, which involves GLP-1 and GIP hormones.

These hormones cause beta cells in the pancreas to produce and secrete more insulin.

They also stop alpha cells from releasing glucagon.

All of this happens based on the amount of glucose that is in the blood.

Therapeutic Applications

Therapeutic class: Antidiabetic agent

It enhances glycemic regulation in people with T2DM.

It is an antidiabetic agent that is generally weight-neutral and has a minimal risk of hypoglycemia.

It is one of the most often prescribed DPP-4 inhibitors across the globe.

It does not cause weight gain, carries a low risk of hypoglycemia, and is well-tolerated by most patients.

Specification Parameters

  • CAS number is 654671-77-9

  • C₁₆H₁₅F₆N₅O·H₃PO₄·H₂O is the molecular formula for the monohydrate.

  • Molecular weight is around 523.32 g/mol.

  • IUPAC name is 7-[(3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (monohydrate)

  • Comes in crystalline powder that is white to off-white

  • It dissolves well in water, sparingly soluble in methanol, insoluble in acetone.

  • Melting Point is 206–214 °C (decomposition)

  • Assay is at least 99.0%

    Packaging & Storage

    Sitagliptin Phosphate Monohydrate / Hydrochloride is packed properly in our industry.

    This keeps it safe and stable while it is being moved and stored.

    Fiber drums are the most common way to get the API. There are two polyethylene bags inside them.

    Also, to keep out dirt, light, and moisture, each container is completely sealed.

    For storage, the product should be kept in a cool, dry, and air flow type place that is not in harsh sunlight or next to hot temperatures.

    To maintain its chemical stability and shelf life, it should be stored at a temperature between 2 and 8 °C.

    In these conditions, the material keeps its quality for up to 24 months after it was made.

    Why Choose Us

    • International GMP Compliance: It is manufactured according to WHO-GMP, EU-GMP, and ICH Q7 quality standards

    • Support from the government: We provide documents like DMF (Drug Master File), CoA, MSDS, and Stability Data. These papers are essential for many global markets.

    • Consistent Purity: The assay values are 99% or above, and there are extremely few contaminants. This makes sure that APIs work reliably in formulations.

    • Flexible Supply Chain: The ability to make more or less of a product for both small and large orders

    • Technical assistance: A special R&D and formulation support team is there to assist you in making the most of your completed dosage forms.

    • Cost-Effectiveness: Prices that are competitive without sacrificing quality or following the rules