BRIEFING
Apremilast Tablets. Because there is no existing USP monograph for this drug product, 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 validation performed with the Inertsil C8-3 brand of column with L7 packing. The typical retention time for apremilast is about 12 min.
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The liquid chromatographic procedure in the Dissolution test is based on validation performed with the Inertsil C8-3 brand of column with L7 packing. The typical retention time for apremilast is about 3 min.
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The liquid chromatographic procedure in the Organic Impurities test is based on validation performed with the YMC Triart brand of column with L1 packing. The typical retention time for apremilast is about 40 min.
(SM2: S. Parepalli)
Case ID—SUB-1227