Product Overview
The active salt form of dapagliflozin is dapagliflozin propanediol monohydrate.
It is a potent and reversible blocker of the sodium-glucose cotransporter-2 (SGLT2) protein.
This API is a huge step forward in the fight against type 2 diabetes (T2DM).
It lowers glucose levels without the need for insulin.
Dapagliflozin functions by preventing SGLT2 from working in the proximal renal tubules.
This makes the kidneys take in less glucose, and the body gets rid of more glucose in urine.
Because of this, blood sugar levels go down.
When dapagliflozin is mixed with propanediol as a monohydrate, it is more stable and bioavailable.
Because of this, it is a good option for long-term care. Dapagliflozin does more than just lower blood sugar.
It makes the risk of cardiac problems much lower. It also slows down kidney disease and problems.
At our company, we have strict guidelines and safety measures taken while manufacturing this API.
Therapeutic Applications
Dapagliflozin Propanediol Monohydrate is utilised to treat a number of conditions, mostly in endocrinology and nephrology:
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Type 2 Diabetes Mellitus (T2DM): Adults can take this alone or with other diabetes drugs to help keep their blood sugar levels stable.
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Heart Failure: This API reduces the risk of hospitalization for heart failure and cardiovascular death in adults with T2DM and established cardiovascular disease.
Specification Parameters
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Chemical name: Dapagliflozin Propanediol Monohydrate.
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CAS Number: 1056036-79-0
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Molecular formula: C24H33ClO8
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Weight of a molecule: 480.97 g/mol
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Physical outlook: A white to off-white coloured crystalline powder
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Identification: Matches IR spectroscopy and retention time through HPLC
Packaging & Storage
Dapagliflozin propanediol monohydrate is stored and packaged under rigorous conditions to keep the API stable and intact.
The main packaging is HDPE drums with double-layer LDPE liners and seals that show if they have been tampered with.
Nitrogen is flushed into the inner packing to keep moisture and oxidation out.
Keep in a cool, dry, airy place in a container that is well closed.
The best temperature for storage is below 25°C. Light, moisture, and direct heat sources must not be able to reach the product.
When kept in the right circumstances, it will last for 36 months after it was made.
Why Choose Us
We have Dapagliflozin Propanediol Monohydrate. It is made to the highest standards.
Our APIs meet all the regulations for pharmaceuticals around the world.
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GMP and regulatory compliance: We manufacture at facilities that WHO-GMP/ICH has approved. When necessary, we follow global standards as well.
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Proper Documents: We have all the regulatory paperwork we need, including the full DMF (Drug Master File), technical dossier, stability data, and method validation documents.
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Advanced Manufacturing Capabilities: We use current methods for synthesis, purification, and crystallization to ensure uniformity, high yield, and low levels of impurities.
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Quality Control and Assurance: We examine the quality of our work at many points. We use both our quality control labs and third-party testing to make sure our goods are safe, work well, and are always the same.
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Responsive Support: Our specialists are here to help with regulatory, formulation, and analytical issues. Our expertise ensures a seamless process for our clients.
