Paroxetine HCl Hemihydrate EP Impurity I Paroxol HCl (N-Desmethyl Paroxol Hydrochloride) | CAS 220548-73-2 | é uma impureza relacionada estruturalmente à paroxetina | identificada como (3S | 4R)-4-(4-fluorofenil)-3-piperidinemetanol cloridrato; sua presença é crítica para controle de qualidade devido a possíveis implicações farmacológicas e toxicológicas. A caracterização exige metodologias analíticas avançadas | incluindo HPLC com detecção UV para triagem | LC-MS/MS para confirmação de massa e RMN para determinação estereoquímica. Procedimentos validados devem abordar limites aceitáveis | linearidade | sensibilidade e precisão conforme monografia EP | assegurando monitoramento consistente durante desenvolvimento e produção farmacêutica.
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