Budesonide EP Impurity D, also designated 21-Dehydro Budesonide, is an oxidized corticosteroid-related process impurity of the inhaled glucocorticoid budesonide. It reflects dehydrogenation at the 21-position and may arise during synthesis or through oxidative degradation of the parent acetal-lactone framework. With CAS 85234-63-5, molecular formula C25H32O6, and molecular weight 428.52 g/mol, it remains structurally close to the active substance, requiring chromatographic resolution by LC-MS/MS or high-resolution LC-MS, with confirmatory NMR when necessary. Its characterization is relevant to impurity profiling, stability assessment, and regulatory specification setting for steroidal pharmaceuticals.
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