General Information

Eplerenone Impurities and Eplerenone 

Daicel Pharma offers high-quality impurities for Eplerenone, an active pharmaceutical ingredient. These impurities, including 6β-Hydroxyeplerenone, Eplerenone EP Impurity C, Eplerenone EP Impurity E, Eplerenone EP Impurity F, Eplerenone EP Impurity G, Eplerenone Impurity A, Eplerenone Impurity B, and Eplerenone Impurity D, play a vital role in assessing the purity, reliability, and safety of Eplerenone. Daicel Pharma also offers a customized synthesis of Eplerenone impurities to cater to client requirements, with worldwide delivery options available.

Eplerenone [CAS: 107724-20-9] is a medication for managing hypertension, congestive heart failure, and post-myocardial infarction. It is a selective aldosterone receptor antagonist and a derivative of spironolactone. Eplerenone also acts as a potassium-sparing diuretic. Its primary therapeutic application is in the treatment of hypertension.

Eplerenone: Use and Commercial Availability  

Eplerenone, marketed under Inspra, is an aldosterone antagonist. It is more selective for the mineralocorticoid receptor compared to glucocorticoid, progesterone, and androgen receptors. Eplerenone improves survival in stable patients with congestive heart failure and left ventricular systolic dysfunction after myocardial infarction and for treating hypertension alone or in combination with other agents.

Eplerenone Structure and Mechanism of Action

The chemical name of Eplerenone is (7α,11α,17α)- 9,11-epoxy-17-hydroxy-3-oxo- γ-lactone, Pregn-4-ene-7,21-dicarboxylic acid methyl ester. Its chemical formula is C₂₄H₃₀O₆, and its molecular weight is approximately 414.5 g/mol.

Eplerenone blocks the binding of aldosterone by binding to the mineralocorticoid receptor. Thus, it decreases sodium resorption and subsequently reduces blood pressure.

Eplerenone Impurities and Synthesis

The presence of impurities in Eplerenone formulations is a concern that requires careful attention to synthesis, analysis, and control. During the synthetic process¹, it is crucial to identify and understand the potential routes that can lead to the formation of impurities. Rigorous analytical techniques, such as high-performance liquid chromatography (HPLC) and mass spectrometry, help analyze and quantify impurities in Eplerenone samples. Effective control measures are implemented throughout the manufacturing process to minimize impurity formation and maintain the purity and quality of Eplerenone.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Eplerenone impurity standards, including 6β-Hydroxyeplerenone, Eplerenone EP Impurity C, Eplerenone EP Impurity E, Eplerenone EP Impurity F, Eplerenone EP Impurity G, Eplerenone Impurity A, Eplerenone Impurity B, and Eplerenone Impurity D. They generate from an analytical facility that complies with cGMP standards. The CoA provides a detailed characterization report with data obtained through techniques such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². We give additional data like 13C-DEPT upon request. Daicel Pharma synthesizes unknown Eplerenone impurities or degradation products. Every delivery has a complete characterization report.