Acetamide, N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]-;
(S)-N-{2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxoisoindolin-4-yl}acetamide [608141-41-9]
BRIEFING
Apremilast. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedure in the Assay and the test for Organic Impurities were validated using the Zorbax SB C-8 brand of column with L7 packing. The typical retention time for apremilast is about 7 min for the Assay and about 26 min for the Organic Impurities test.
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The liquid chromatographic procedure in the Limit of Apremilast R-Enantiomer test was validated using the ChiralPak AD brand of column with L51 packing. The typical retention time for apremilast-R-enantiomer is about 14.5 min.
Description and solubility information: White to pale yellow powder. Slightly soluble in alcohol and practically insoluble in water.
(SM2: H. Ramanathan)
Case ID—SUB-1898