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 proposed.
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The liquid chromatographic procedure in the Assay is based on the validation performed with the ACE C18 brand of column with L1 packing. The typical retention time for apremilast is about 12 min.
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The liquid chromatographic procedure in the Organic Impurities test is based on the validation performed with the ACE C18 brand of column with L1 packing. The typical retention time for apremilast is about 54 min.
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The liquid chromatographic procedure in the Limit of Apremilast R-Enantiomer test is based on the validation performed with the Chiralpak ID brand of column with L126 packing. The typical retention time for apremilast-R-enantiomer is about 6 min.
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The liquid chromatographic procedure in the Limit of N-Acetyl-l-Leucine test is based on the validation performed with the Zorbax C8 brand of column with L7 packing. The typical retention time for N-acetyl-l-leucine is about 5 min.
Description and Solubility information: Off-white to pale yellow with greenish shade color powder. Soluble in acetone; sparingly soluble in acetonitrile; and insoluble in water.
(SM2: S. Parepalli)
Case ID—SUB-1226
USP REFERENCE STANDARDS FOR PURCHASE
USP Apremilast R-Enantiomer RSUSP Apremilast RS
USP Apremilast Related Compound E RS
USP N-Acetyl-l-leucine RS