Los derivados Di-C-Nitroso del propil galato son impurezas nitrosadas que se forman por nitrosación de antioxidantes fenólicos durante procesos de síntesis o almacenamiento. Estas impurezas presentan riesgo por su posible genotoxicidad y afectan la estabilidad y el perfil de seguridad del lote. Su identificación y cuantificación requieren técnicas analíticas robustas como HPLC con detección UV/PDA, LC-MS/MS y confirmación por espectrometría de masas de alta resolución. La implementación de controles de proceso, límites basados en guías ICH y estudios de degradación forzada permiten mitigar su aparición. Se recomienda monitoreo rutinario en materias primas, etapas intermedias y producto terminado.
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To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
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