Eplerenone

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6β-Hydroxyeplerenone

  • CAT NUMBER DCTI-C-2455
  • CAS NUMBER 209253-80-5
  • MOLECULAR FORMULA C24H30O7
  • MOLECULAR WEIGHT 430.5

Eplerenone EP Impurity C

  • CAT NUMBER DCTI-C-2029
  • CAS NUMBER 95716-70-4
  • MOLECULAR FORMULA C24H30O5
  • MOLECULAR WEIGHT 398.5

Eplerenone EP Impurity E

  • CAT NUMBER DCTI-C-2260
  • CAS NUMBER 209253-81-6
  • MOLECULAR FORMULA C24H30O6
  • MOLECULAR WEIGHT 414.5

Eplerenone EP Impurity F

  • CAT NUMBER DCTI-C-2456
  • CAS NUMBER 579484-30-3 (Free Base); 95716-98-6 (Potassium salt)
  • MOLECULAR FORMULA C24H32O7 (Free base); C24H32O7K (Potassium salt)
  • MOLECULAR WEIGHT 432.51 (Free base); 471.61 (Potassium salt)

Eplerenone EP Impurity G

  • CAT NUMBER DCTI-C-2457
  • CAS NUMBER 41020-65-9
  • MOLECULAR FORMULA C24H32O5
  • MOLECULAR WEIGHT 400.52

Eplerenone Impurity A

  • CAT Number DCTI-C-1689
  • CAS Number 209253-67-8
  • Molecular Formula C23H28O5
  • Molecular Weight 384.47

Eplerenone Impurity B

  • CAT Number DCTI-C-1690
  • CAS Number 192704-82-8
  • Molecular Formula C24H30O6
  • Molecular Weight 414.5

Eplerenone Impurity D

  • CAT Number DCTI-C-1691
  • CAS Number 209253-82-7
  • Molecular Formula C23H28O6
  • Molecular Weight 400.47

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 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.

 

References
FAQ's

Frequently Asked Questions

The presence of impurities in Eplerenone can influence its absorption, distribution, metabolism, and excretion, potentially altering its pharmacokinetic properties.

Impurities in Eplerenone can cause adverse effects or toxicity, depending on their nature, concentration, and interaction with the body.

Methanol or Acetonitrile are the solvents used for analyzing most of the impurities in Eplerenone.

Eplerenone impurities are stored at a controlled room temperature, between 2-8 ⁰C, or according to Certificate of Analysis (CoA) specifications.

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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