Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, γ-lactone, methyl ester, (7α,11α,17α)-;
9,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone [107724-20-9]
BRIEFING
Eplerenone. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the Inertsil ODS-3 C18 brand of column with L1 packing. The typical retention time for eplerenone is about 10.2 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Inertsil ODS-3 C18 brand of column with L1 packing. The typical retention time for eplerenone is about 17.5 min.
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The liquid chromatographic procedure in the Limit of Eplerenone 4,5-Epoxy Analog and Eplerenone Caprolactone test was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for eplerenone is about 13.9 min.
Description and solubility information: White to off-white powder. Soluble in dichloromethane; slightly soluble in methanol; very slightly soluble in water.
(SM2: T. Bililign)
Case ID—SUB-720, SUB-721
USP REFERENCE STANDARDS FOR PURCHASE
USP Eplerenone RSUSP Eplerenone Related Compound F RS
USP Eplerenone Related Compound L RS