Impureza Pantoprazol Clorometil (base libre) | CAS 169905-10-6 | conocida también como 2-chloromethyl-3 | 4-dimethoxypyridine | es una impureza sintética crítica en la síntesis de pantoprazol; su presencia indica reacciones de clorometilación incompleta o subproductos de alquilación que afectan la pureza y el perfil de seguridad del principio activo. Se recomienda su cuantificación mediante técnicas validadas como HPLC y LC-MS para control de calidad y cumplimiento de especificaciones. Estudios de estabilidad y procesos de purificación deben optimizarse para minimizar su formación y asegurar límites aceptables | y el seguimiento analítico riguroso facilita la gestión de riesgos regulatorios y la consistencia del lote.
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