Eplerenone

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Methyl Hydrogen-9,11a-epoxy-17 a-hydroxy-3- oxopregn-4-ene-7 a,21-dicarboxylate PRODUCT NAME EplerenoneChemical NameMethyl Hydroge…

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Methyl Hydrogen-9,11a-epoxy-17 a-hydroxy-3- oxopregn-4-ene-7 a,21-dicarboxylate PRODUCT NAME EplerenoneChemical NameMethyl Hydrogen-9,11a-epoxy-17 a-hydroxy-3- oxopregn-4-ene-7 a,21-dicarboxylateTEST STANDARDSDescriptionAn off White to white powderSolubilitySoluble in DichloromethaneMelting Range230°C to 240°CIdentificationA) IR-SpectrumB) By HPLCThe sample infrared spectrum is concordant with that of the spectrum of standard.The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained assay.Loss on dryingNote more than 1.0% w/wResidue on IgnitionNot more than 0.2% w/wHeavy metalsNot more than 20PPMRelated Substances by HPLCImpurity-1 NMT 0.15%Single Impurity NMT 0.1%Total Impurity NMT 1.0%Assay by HPLC(On Dried Basis )Between 98.0 % w/w to 102.0 % w/wResidual Solvents by GCMethanol NMT 3000 PPMAcetone NMT 5000 PPM2-Butanone NMT 5000 PPMCyclohexane NMT 3880 PPMToluene NMT 890 PPMN,N-Dimethyl Formamide NMT 880PPMEthyl Acetate NMT 5000 PPMDichlormethane NMT 600PPM

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