Dapagliflozin

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1α-Methoxy Dapagliflozin

  • CAT NUMBER DCTI-C-1474
  • CAS NUMBER 714269-57-5
  • MOLECULAR FORMULA C22H27ClO7
  • MOLECULAR WEIGHT 438.9

4-Deschloro-4-bromo Dapagliflozin

  • CAT Number DCTI-C-1665
  • CAS NUMBER 1807632-95-6
  • MOLECULAR FORMULA C21H25BrO6
  • MOLECULAR WEIGHT 453.33

5-bromo-2-chloro-4′-ethoxydiphenylmethane

  • CAT Number DCTI-C-1664
  • CAS Number 461432-23-5
  • Molecular Formula C15H14BrClO
  • Molecular Weight 325.63

Dapagliflozin Hydroxy Impurity

  • CAT NUMBER DCTI-C-1473
  • CAS NUMBER 960404-86-8
  • MOLECULAR FORMULA C21H25ClO7
  • MOLECULAR WEIGHT 424.87

Dapagliflozin Impurity-3

  • CAT NUMBER NA
  • CAS NUMBER 2176485-21-3
  • MOLECULAR FORMULA C30H28Cl2O2
  • MOLECULAR WEIGHT 491.45

Dapagliflozin Tetraacetate

  • CAT NUMBER DCTI-C-1472
  • CAS NUMBER 461432-25-7
  • MOLECULAR FORMULA C29H33ClO10
  • MOLECULAR WEIGHT 577.02

Dapagliflozin-D5

  • CAT NUMBER DCTI-A-050
  • CAS NUMBER 1204219-80-6
  • MOLECULAR FORMULA C21H20D5ClO6
  • MOLECULAR WEIGHT 413.91

Monoacetyl Dapagliflozin

  • CAT Number DCTI-C-1756
  • CAS NUMBER 1632287-34-3
  • MOLECULAR FORMULA C23H27ClO7
  • MOLECULAR WEIGHT 450.91

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 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 C21H25ClO6, 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.

References
FAQ's

Frequently Asked Questions

Yes, the control of genotoxic impurities is of utmost importance in Dapagliflozin due to its potentially harmful effects on DNA and increased risk of cancer. There are stringent limits set for genotoxic impurities.

Regulatory authorities such as the FDA and EMA provide guidelines and regulations regarding controlling impurities in Dapagliflozin, ensuring compliance with quality standards.

Acetonitrile is a solvent used for analyzing many impurities in Dapagliflozin.

Dapagliflozin impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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