Impureza N-Nitroso Osimertinib 3-Hydroxy é um degradante processual identificado em lotes de osimertinibe, relevante por sua relação estrutural com nitrosaminas e pela necessidade de monitoramento analítico rigoroso. Apresenta massa molecular e grupo N-nitroso que exigem métodos sensíveis como LC-MS/MS, UHPLC-HRMS e HPLC com validação conforme ICH Q2(R1) para quantificação em níveis traces. Estudos de estabilidade e elucidação das vias de formação ajudam a otimizar condições de síntese e purificação para reduzir sua geração. A avaliação de limites de especificação, recuperação e reprodutibilidade analítica é crítica para garantir conformidade regulatória e qualidade do produto final.
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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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The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
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