General Information

Amiodarone Impurities and Amiodarone

Daicel Pharma synthesizes high-quality Amiodarone impurities, including Amiodarone EP Impurity F, Amiodarone Impurity D, and Amiodarone Impurity E. These impurities are essential for evaluating the quality, stability, and safety of Amiodarone, which is an active pharmaceutical ingredient. Additionally, Daicel Pharma offers a customized synthesis of Amiodarone impurities delivered globally to meet the specific needs of our customers.

Amiodarone [CAS: 1951-25-3] is a medicine that contains iodine and belongs to the benzofuran derivatives. It has properties that can help regulate heart rhythms and increase blood flow. It is a class III antiarrhythmic agent. Amiodarone treats various heart rhythm disorders.

Amiodarone: Use and Commercial Availability  

Amiodarone is an anti-arrhythmic drug used to treat various heart rhythm disorders. It treats life-threatening ventricular arrhythmias. It treats and prevents frequently

recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular

tachycardia (VT) in patients, refractory to other therapy. Amiodarone is available under various brand names, such as Nexterone, Pacerone, etc.

Amiodarone Structure and Mechanism of Action

The chemical name of Amiodarone is (2-Butyl-3-benzofuranyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone. Its chemical formula is C₂₅H₂₉I₂NO₃, and its molecular weight is approximately 645.3 g/mol.

Amiodarone lengthens cardiac action potential, a characteristic of the Vaughan Williams class III effect. It blocks myocardial potassium and sodium channels that prolong refractoriness in the atrioventricular (AV) node.

Amiodarone Impurities and Synthesis

During the synthesis¹ of Amiodarone, impurities can form and harm patients. These impurities may lead to the degradation of Amiodarone or byproducts from the synthetic process. It is necessary to control these impurities as they can cause harm, such as liver and lung toxicity, and decrease drug efficacy.

Daicel Pharma provides a Certificate of Analysis (CoA) for Amiodarone impurity standards, including Amiodarone EP Impurity F, Amiodarone Impurity D, and Amiodarone Impurity E. The CoA is 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 upon request. Daicel Pharma is capable of creating unknown Amiodarone impurities or degradation products. Each delivery comes with a complete characterization report.