N-Nitroso Trazodone ? uma impureza nitrosamina identificada em mat?rias-primas e produtos farmac?uticos relacionados ao trazodone que requer monitoramento rigoroso. Sua forma??o ocorre por nitrosa??o de aminas secund?rias em presen?a de nitritos sob condi??es ?cidas ou t?rmicas | e apresenta preocupa??es toxicol?gicas t?picas das nitrosaminas | motivando limites anal?ticos baixos. M?todos anal?ticos sens?veis por GC-MS ou LC-MS/MS com valida??o para limite de quantifica??o s?o recomendados para detec??o e quantifica??o. Estrat?gias de controle incluem otimiza??o de s?ntese | remo??o de precursores | controle de nitritos e estudos de estabilidade forense. A gest?o proativa reduz risco regulat?rio e preserva a seguran?a do produto final.
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