Impureza Clorhexidina (1111001) | CAS 55-56-1 | se presenta como contaminante residual en procesos de síntesis y puede afectar la pureza y la estabilidad del lote final. Características analíticas incluyen perfil cromatográfico en HPLC con detectores UV | confirmación por LC-MS y espectroscopía NMR e IR para identificación estructural. Su cuantificación requiere métodos validados con límites de detección y cuantificación definidos; especificaciones típicas establecen límites según directrices ICH Q3A/Q3B. El control de impurezas se logra mediante optimización de condiciones de reacción | etapas de lavado y cromatografía preparativa | junto con monitoreo de almacenamiento para minimizar degradación y formación de impurezas relacionadas.
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