Impureza Anastrozol Formil (CAS 120511-89-9) é uma impureza relacionada observada em lotes de síntese e em estudos de estabilidade do anastrozol | caracterizada por um grupo formil incorporado à estrutura molecular. De importância analítica e regulatória | sua identificação e quantificação são realizadas por HPLC com detecção UV | LC-MS para confirmação de massa e RMN para elucidação estrutural. Estudos de perfil de degradação e controle de processo definem limites aceitos conforme diretrizes ICH | empregando métodos validados | técnicas de purificação como cromatografia e otimização de condições de síntese para minimizar sua formação e garantir conformidade de qualidade.
Referências
Gangadhara, Sharath, and Gianfilippo Bertelli. “Long-Term Efficacy and Safety of Anastrozole for Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women.†Therapeutics and Clinical Risk Management, vol. 5, 2009, pp. 291–300, www.ncbi.nlm.nih.gov/pmc/articles/PMC2690973/.
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