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Eplerenone Tablets

BRIEFING

 Eplerenone Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

  1. The liquid chromatographic procedure in the Assay was validated using the ChromBudget C18 brand of column with L1 packing. The typical retention time for eplerenone is about 3.2 min.

  2. The liquid chromatographic procedure in the test for Organic Impurities was validated using the ChromBudget C18 brand of column with L1 packing. The typical retention time for eplerenone is about 13.7 min.

 (SM2: T. Bililign)

 Case ID—SUB-722

USP REFERENCE STANDARDS FOR PURCHASE

USP Eplerenone RS
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