Awaiting product image

Dapagliflozin Propanediol Monohydrate API

Name of Product Dapagliflozin Propanediol Monohydrate API
CAS No 960404-48-2
Therapeutic use:- SGLT2 inhibitor – type 2 diabetes management
Form:- API Powder
Grade USP/IH
Status Commercial
Inquire About Dapagliflozin Propanediol Monohydrate API
Inquiry in product detail page

We are a 100% export-oriented company and do not engage in domestic sales within India.

Product Overview

Dapagliflozin Propanediol Monohydrate (1056036-79-0) is an active pharmaceutical ingredient (API).

It belongs to the class known as SGLT2 inhibitors. They function in the kidneys.

They block the sodium-glucose co-transporter 2 (SGLT2) in the proximal tubules of the kidney, reducing glucose reabsorption and increasing urinary glucose excretion.

The excess sugar then leaves the body through urine.

There are additional effects, as per studies. It can cause weight reduction. It can lower blood pressure.

It lowers the risk of heart complications, too. In some cases, it protects the kidneys.

The drug is an off-white or white crystalline powder. It dissolves in most solvents.

It is stable under proper storage conditions. 

Therapeutic Applications

It is used most frequently in type 2 diabetes. It is blended with sulfonylureas, metformin, or insulin.

It is beneficial as it lowers blood sugar through a unique renal mechanism, distinct from other antidiabetic agents.

It also helps in chronic kidney disease (CKD). CKD patients can reduce the progression of kidney impairment while taking this drug.

It can delay the progression to dialysis in CKD patients. It is also used in heart failure with reduced ejection fraction (HFrEF).

It reduces mortality from heart disease.

Specification Parameters

  • Appearance- White or off-white crystalline powder.

  • Identification- Tested with high-performance liquid chromatography (HPLC) and mass spectrometry. 

  • Assay (Purity Content)- Purity will generally be a minimum of 99%. 

  • Water Content- Low water content will prevent the product from being unstable in storage.

  • Residual Solvents- Needs to meet International Council for Harmonisation (ICH) guidelines. Amounts are always monitored and kept well below specifications.

  • Heavy Metals & Impurities- Low impurities. Heavy metals should also be within acceptable limits. 

  • Microbial Limits- Microbial growth should be maintained under control.

  • Particle Size Distribution- Uniform size improves mixing and blending. Helps in manufacturing tablets or capsules.

  • Stability- Analyzed for long-term and accelerated storage. 

    Packaging & Storage

    Packaging Options:

    • Supplied in HDPE drums. Two inner polyethylene bags are supplied in one drum for extra safety.

    • Pack sizes offered are 1 kg, 5 kg, 10 kg, and 25 kg. Special pack sizes can also be offered.

    • The containers are sealable and tamper-evident. This will protect the product stored as well as shipped.

      Storage Instructions:

      • Keep in cool, dry conditions.

      • Stay away from direct sunlight.

      • Do not store in moist conditions.

      • Store at 15°C to 30°C

      • Close the container tightly after opening.

        Why Choose Us

        Actiza is a distributor of Dapagliflozin Propanediol Monohydrate and other APIs.

        We enjoy the confidence of many international associates.

        • GMP and Compliance- We follow guidelines from the USFDA, the EU, and WHO.

        • Quality Control- Each batch is tested many times. Purity, safety, and consistency are always guaranteed.

        • Flexible Supply- We provide small quantities for research. We also provide bulk quantities for final production.

        • Global Reach- We export to more than 45 countries.

        • Documentation Support- We provide Drug Master Files, validation reports, and stability reports.

        • Client Service- Our team serves clients with consistent and flexible service.

        • Sustainability and Safety- We carry out processes that are safe and sustainable. The safety of employees and the protection of the environment are the utmost priorities.