Impureza 27 de pantoprazol (CAS 1166386-02-2) es un contaminante identificado en el perfil de impurezas del principio activo pantoprazol | relevante para control de calidad y cumplimiento regulatorio. Su identificación requiere técnicas analíticas sensibles como HPLC con detección UV | LC-MS para confirmación de masa y RMN para elucidación estructural. Esta impureza puede formarse por degradación o reacciones secundarias durante síntesis y almacenamiento | y su cuantificación es crítica para establecer límites según ICH Q3A/Q3B. Se recomienda disponer de un estándar de referencia | validar métodos analíticos y aplicar estrategias de control en proceso y en lote terminado para garantizar la seguridad y calidad del API.
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