Impureza Anastrozol Monoamida Mononitrila (CAS 1338800-82-0) | também referida como Anastrozol Amida Nitrila | é um subproduto de síntese identificado durante a produção de anastrozol. Caracteriza-se por estrutura contendo grupos amida e nitrila que pode afetar o perfil de pureza e a estabilidade do lote. O acompanhamento quantitativo é realizado por técnicas analíticas robustas como HPLC com detector UV | LC-MS e RMN para confirmação estrutural | além de ensaios de impurezas relacionadas conforme ICH Q3A. Fornecemos material de referência e dados de especificação para suporte ao controle de qualidade | limites de aceitação e investigação de vias de formação para mitigação no processo.
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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