Levodopa (CAS 59-92-7) como impureza exige control riguroso en el perfil de impurezas por su potencial para afectar estabilidad y pureza del lote. Esta impureza se identifica y cuantifica mediante técnicas validadas como HPLC con detección UV | LC-MS/MS y NMR para confirmar estructura y epimerización; los métodos de muestreo y preparación se optimizan para evitar artefactos de degradación. Los criterios de aceptación se establecen según ICH Q3A/Q3B con límites basados en toxicidad y exposición | mientras que las estrategias de control incluyen especificaciones de materia prima | condiciones de síntesis | estudios forzados y perfiles de degradación.
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