Apremilast sulfone impurity, also designated Apremilast Impurity 17, is the oxidized sulfone analogue of the phosphodiesterase 4 inhibitor apremilast and corresponds to CAS 2487573-01-1. With molecular formula C23H26N2O8S and molecular weight 490.54 g/mol, it reflects overoxidation at the thioether-derived sulfur center during synthesis or storage. This impurity is evaluated as a process and degradation-related species rather than a mutagenic alert structure. Trace characterization typically requires LC-MS/MS, HRMS, and orthogonal HPLC methods, with UV confirmation where applicable. Structural assignment is facilitated by comparative mass shift analysis and impurity profiling.
References
Schafer, Peter. “Apremilast Mechanism of Action and Application to Psoriasis and Psoriatic Arthritis.†Biochemical Pharmacology, vol. 83, no. 12, June 2012, pp. 1583–90, https://doi.org/10.1016/j.bcp.2012.01.001.
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