Impureza Citalopram EP Impurity F (oxalato) | CAS 64372-43-6 | também referida como Citalopram Related Compound H | é o composto 3-(5-bromo-1-(4-fluorofenil)-1 | 3-dihidroisobenzofuran-1-il)-N | N-dimetilpropan-1-amina oxalato identificado como impureza relevante no perfil de qualidade do API citalopram. A presença da forma oxalato altera cristalização e solubilidade | afetando isolamento e rendimento | e por isso exige monitorização analítica rigorosa por HPLC | LC-MS e RMN para quantificação e caracterização estrutural. Estudos de estabilidade | definição de limites de especificação e medidas de controle de processo são recomendados para mitigar impacto na pureza e assegurar conformidade com monografias EP.
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