You're viewed 9 of 12 products
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 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.
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 C25H20N4O5, 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.
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.
Impurities in Azilsartan are detected and quantified using different analytical techniques such as HPLC, LC-MS, etc.
Genotoxic impurities are substances that can damage DNA and potentially cause cancer. They are typically present in low levels of drug substances.
Impurities in Azilsartan can be minimized during manufacturing by using high-quality starting materials, optimizing reaction conditions, and implementing appropriate purification steps.
Impurities in Azilsartan can vary between batches due to factors such as the quality of starting materials, manufacturing process, and storage conditions.
Azilsartan impurities are stored at recommended temperature conditions, typically 2-8°C or -20°C depending on their stability.
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.