4-Hydroxy Clonidina (CAS 57101-48-1) es una impureza relacionada con clonidina, hidroxilada, con fórmula molecular C9H9Cl2N3O y masa molecular de 246.09 g/mol. Como producto fenólico de oxidación o de biotransformación del núcleo imidazolina, constituye un análogo estructuralmente modificado que puede generarse durante degradación oxidativa, hidroxilación metabólica o reacciones secundarias del proceso. Su funcionalidad fenólica polar altera la retención cromatográfica y el comportamiento de ionización frente al compuesto parental. La determinación en trazas suele requerir LC-MS/MS con confirmación por espectrometría de masas de alta resolución, junto con métodos ortogonales HPLC-UV o LC-UV para el perfil de impurezas. La evaluación regulatoria se enmarca en ICH Q3A/Q3B.
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