Impureza Vildagliptin Chloroacetyl Nitrile (isômero R) | CAS 565452-98-4 | é um subproduto estereoquímico formado durante etapas de cloroacetilação do análogo pirrolidina; apresenta nitrila e grupo cloroacetil que influenciam polaridade e reatividade. A presença deste isômero impacta perfil de pureza e pode afetar rendimento e estabilidade do sítio ativo | por isso é crítico monitorar por HPLC quiral e não quiral | LC-MS | RMN 1H/13C e análises de impurezas relacionadas a ICH Q3A/Q3B. Controle inclui otimização de condições de síntese | purificação por cromatografia e definição de limites aceitáveis em especificação. Fornecido com certificado de análise e dados analíticos completos.
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