Fenoxibenzamina clorhidrato CRS (Y0002282) | CAS: 63-92-3 | se considera una impureza relacionada crítica en materias primas y productos intermedios; su presencia puede alterar el perfil de pureza | la estabilidad y el comportamiento cromatográfico del lote. Debido a su naturaleza amínica y contenido de cloro requiere identificación y cuantificación mediante técnicas analíticas robustas como HPLC-UV | LC-MS y caracterización por RMN. Los límites y criterios de aceptación deben establecerse según guías regulatorias aplicables como ICH Q3A | complementados con ensayos de humedad y de residuos de solventes cuando proceda | y un control de lote y trazabilidad documentada para mitigar riesgos de calidad.
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