General Information

Azilsartan Impurities and Azilsartan 

Daicel Pharma provides high-quality Azilsartan impurities, including Azilsartan AZLRC-10, Azilsartan Hydroxy Acid, Azilsartan Impurity 23 (A-8443), Azilsartan medoxomil-Amide Impurity, Azilsartan Medoxomil-Desethoxy Impurity, Azilsartan medoxomil-Dimer Impurity, and Ethyl-2-ethoxy-3-((2′-(N’-hydroxycarbamimidoyl). These impurities are essential for evaluating the quality, stability, and safety of Azilsartan, which is an active pharmaceutical ingredient. Additionally, Daicel Pharma offers a customized synthesis of Azilsartan impurities for global delivery to meet the specific needs of our customers.

Azilsartan [CAS: 147403-03-0] is a medication that manages and treats hypertension. Its primary functions are to block the angiotensin receptors and act as an antihypertensive agent. It is a benzimidazole carboxylic acid derivative.

Azilsartan: Use and Commercial Availability  

Azilsartan is a drug that belongs to angiotensin II receptor blockers (ARBs) and is commercially available as Azilsartan medoxomil or in combination with other hypertensives. Azilsartan medoxomil is a prodrug, which hydrolyses to Azilsartan in the gastrointestinal tract during

absorption. Further, it prevents the recurrence of atrial fibrillation. It is available under the brand name Edarbi.

Azilsartan Structure and Mechanism of Action

The chemical name of Azilsartan is 1-[[2′-(2,5-Dihydro-5-oxo-1,2,4-oxadiazol-3-yl)[1,1′-biphenyl]-4-yl]methyl]-2-ethoxy-1H-benzimidazole-7-carboxylic acid. Its chemical formula is C₂₅H₂₀N₄O_5, and its molecular weight is approximately 456.4 g/mol.

Azilsartan selectively blocks the binding of angiotensin II to the AT1 receptor in tissues like vascular smooth muscle and the adrenal gland, thus blocking the vasoconstrictor and aldosterone-secreting effects of angiotensin II.

Azilsartan Impurities and Synthesis

During manufacturing¹, Azilsartan impurities arise due to various factors such as starting materials, synthetic processes, and degradation products. These impurities can affect the drug’s quality, safety, and efficacy, making it necessary to control them.

Daicel Pharma provides a Certificate of Analysis (CoA) for Azilsartan impurity standards, including Azilsartan AZLRC-10, Azilsartan Hydroxy Acid, Azilsartan Impurity 23 (A-8443), Azilsartan medoxomil-Amide Impurity, Azilsartan Medoxomil-Desethoxy Impurity, Azilsartan medoxomil-Dimer Impurity, and Ethyl-2-ethoxy-3-((2′-(N’-hydroxycarbamimidoyl). The CoA is generated from a cGMP-compliant analytical facility and includes comprehensive characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We can also give additional characterization data like 13C-DEPT and CHN on request. Daicel Pharma is capable of creating unknown Azilsartan impurities or degradation products. Each delivery has a complete characterization report.