A Impureza D da EP de budesonida, também denominada 21-Dehydro Budesonide, é uma impureza de processo oxidada relacionada ao corticosteroide inalatório budesonida. Corresponde a uma desidrogenação na posição 21 e pode formar-se durante a síntese ou por degradação oxidativa do esqueleto acetal-lactona do composto parental. Com CAS 85234-63-5, fórmula molecular C25H32O6 e massa molecular 428,52 g/mol, mantém elevada proximidade estrutural com o fármaco, exigindo resolução cromatográfica por LC-MS/MS ou LC-MS de alta resolução, com confirmação por RMN quando necessário. Sua caracterização é relevante para o perfil de impurezas e para a definição de especificações regulatórias de esteroides.
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