Enalapril Impurity 19 es una impureza quiral derivada de la unidad alanyl-prolina que contiene un grupo etoxicarbonilo y un propilo fenilo | con configuración (2S) en centros clave. Su perfil analítico se caracteriza por la presencia de grupos amida | éster y ácido carboxílico | lo que condiciona su comportamiento frente a hidrólisis | epimerización y reacciones de oxidación durante síntesis y almacenamiento. Se detecta y cuantifica mediante HPLC con detección UV y LC-MS para confirmación de masa | complementado por RMN para asignación estereoquímica. La evaluación de sus niveles y límites conforme a guías de impurezas es crítica para el control de calidad del API.
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