Informações adicionais sobre o CAS 13078-15-4; 65369-76-8
Fármaco de origem
Trazodone/ Nefazodone
Nome IUPAC
1-(3-Chlorophenyl)piperazine HCl
Sinônimos
Nefazodone CPP Impurity
Descrição
A impureza 1-(3-clorofenil)piperazina (sal de HCl) | identificada pelos CAS 13078-15-4 e 65369-76-8 | é um subproduto crítico em processos de síntese de trazodona e referida como Nefazodone CPP Impurity; do ponto de vista analítico | requer monitorização rigorosa por HPLC | LC-MS e RMN para caracterização e quantificação devido ao seu potencial impacto na pureza do lote e no perfil de segurança do princípio ativo; estudos de estabilidade e validação analítica devem estabelecer limites aceitáveis conforme diretrizes ICH | com estratégias de purificação e controle de processo para minimizar sua formação e garantir conformidade regulatória.
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