Acetilcisteína (907) | CAS 616-91-1 | como impureza en materias primas farmacéuticas surge por acetilación incompleta | hidrólisis y oxidación del grupo tiol a disulfuros. Su presencia puede alterar el perfil cromatográfico | enmascarar picos analíticos y comprometer la determinación de pureza y estabilidad del principio activo. Se recomienda su monitorización mediante HPLC con detección UV y confirmación por LC-MS | complementada con ensayos redox y cromatografía iónica si procede. Los límites deben establecerse conforme a ICH Q3A/Q3B y evaluación de riesgo. Un control robusto del proceso | pH | agentes reductores y condiciones de almacenamiento minimiza su formación.
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