Impureza Bicalutamida EP Impurity K | também referida como Bicalutamide JP Related substance K | é um produto de degradação identificado no perfil de impurezas da bicalutamida. Caracteriza-se por propriedades cromatográficas e espectrais específicas que requerem quantificação robusta e sensível. Indicadores analíticos incluem retenção compatível em métodos HPLC validados com detecção UV | confirmação estrutural por LC-MS e RMN e determinação de conteúdo residual para avaliação de estabilidade e pureza. O controle desta impureza é crítico para conformidade com monografias EP e JP e para assegurar especificações de qualidade | sendo incluída em protocolos de liberação e estudos de estabilidade.
Referências
Neyman, A., Fuqua, J. S., & Eugster, E. A. (2019). Bicalutamide as an Androgen Blocker With Secondary Effect of Promoting Feminization in Male-to-Female Transgender Adolescents. Journal of Adolescent Health, 64(4), 544–546. https://doi.org/10.1016/j.jadohealth.2018.10.296
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