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Eplerenone impurities include process-related substances, degradation products, and structurally related analogs that may arise during synthesis, formulation, or storage. These impurities are carefully monitored to ensure the safety, efficacy, and quality of this aldosterone antagonist used in the treatment of hypertension and heart failure. All materials are structurally confirmed and qualified under ICH guidelines for pharmaceutical analysis and toxicological evaluation.
We offer pharmacopeial and non-pharmacopeial Eplerenone impurities that comply with European Pharmacopoeia (EP) specifications. These impurity standards are essential for method development, impurity profiling, and stability testing. Analytical techniques such as HPLC, LC-MS, and NMR are used for their identification and quantification. EP traceable standards are available upon request.
Our catalog includes Eplerenone-related compounds that support forced degradation studies, impurity identification, and genotoxicity screening. These materials are structurally characterized and supported by comprehensive analytical documentation, ensuring suitability for regulatory submissions and quality control.
Eplerenone impurity reference standards are supplied with validated analytical data including NMR, MS, and HPLC purity. These materials are used in pharmaceutical R&D, ANDA and DMF filings, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request, and all products meet international regulatory expectations. Supplied materials are re-tested at regular intervals to ensure consistency.
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