General Information

Dapagliflozin Impurities and Dapagliflozin

Daicel Pharma synthesizes Dapagliflozin impurities of exceptional quality, such as 1α-Methoxy Dapagliflozin, 4-Deschloro-4-bromo Dapagliflozin, 5-bromo-2-chloro-4′-ethoxydiphenylmethane, Dapagliflozin Hydroxy Impurity, Dapagliflozin Tetraacetate, and Monoacetyl Dapagliflozin. These impurities are crucial to assess the purity, reliability, and safety of an active pharmaceutical ingredient, Dapagliflozin. Besides, Daicel Pharma provides custom synthesis of Dapagliflozin impurities to meet clients’ demands for delivery worldwide.

Dapagliflozin [CAS: 461432-26-8], a selective inhibitor of sodium-glucose cotransporter subtype 2 (SGLT2), exhibits potent antihyperglycemic activity. This selective inhibition of SGLT2 enhances its effectiveness in improving glycemic control in adults with type 2 diabetes when used in conjunction with diet and exercise. Dapagliflozin helps individuals seeking to manage their blood glucose levels.

Dapagliflozin: Use and Commercial Availability  

Dapagliflozin, available under the brand name Farxiga, improves glycemic control in adult patients with type 2 diabetes mellitus. It is useful where metformin is not suitable due to intolerance or in addition to other medications for treating type 2 diabetes. Additionally, it treats symptomatic chronic heart failure with reduced ejection fraction and chronic kidney disease in adults.

Dapagliflozin Structure and Mechanism of Action

The chemical name of Dapagliflozin is (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol. Its chemical formula is C₂₁H₂₅ClO_6, and its molecular weight is approximately 408.9 g/mol.

Dapagliflozin inhibits Sodium-glucose cotransporter 2 (SGLT2) and reduces the reabsorption of filtered glucose. It decreases the renal threshold for glucose while increasing urinary glucose excretion.

Dapagliflozin Impurities and Synthesis

During the synthesis¹, storage, or degradation of Dapagliflozin, impurities generate. These impurities can originate from various sources, including raw materials, reaction by-products, or degradation of the drug substance. Analytical techniques like HPLC, LC, and MS help identify and quantify these impurities. Strict control measures are necessary to ensure the quality and safety of Dapagliflozin, including setting impurity specifications and implementing robust manufacturing processes.

Daicel Pharma offers a Certificate of Analysis (CoA) for Dapagliflozin impurity standards, such as 1α-Methoxy Dapagliflozin, 4-Deschloro-4-bromo Dapagliflozin, 5-bromo-2-chloro-4′-ethoxydiphenylmethane, Dapagliflozin Hydroxy Impurity, Dapagliflozin Tetraacetate, and Monoacetyl Dapagliflozin, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Furthermore, on request, we give additional data like 13C-DEPT and CHN. Daicel Pharma can synthesize unknown Dapagliflozin impurities or degradation products. A complete characterization report accompanies every delivery.