3H-Pyrazol-3-one, 2,4-dihydro-5-methyl-2-phenyl-;
5-Methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3-one [89-25-8]
BRIEFING
Edaravone. 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 and the test for Organic Impurities was validated using the MCI-GEL ODS-1HU brand of column with L1 packing. The typical retention time for edaravone is about 4 min.
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The liquid chromatographic procedure in the test for Limit of Phenylhydrazine was validated using the YMC-Pack Pro C18 brand of column with L1 packing. The typical retention time for phenylhydrazine is about 4 min.
Description and solubility information: White to pale yellow-white, crystals or crystalline powder. Freely soluble in ethanol and in acetic acid; slightly soluble in water.
(SM4: D. Singh)
Case ID—SUB-1018