Allopurinol Nitrile Impurity (CAS: 16617-46-2) é uma impureza nitrila observada na síntese de allopurinol. Caracteriza-se pela presença do grupo cianeto | maior lipofilicidade relativa ao API e tendência a coeluir com intermediários aromáticos. Exige monitoramento por HPLC e LC-MS para quantificação e identificação estrutural por RMN. Pode afetar pureza | estabilidade e conformidade regulatória se não controlada. Estratégias analíticas e de processo incluem otimização de etapas de reação | purificação por cromatografia e especificações segundo ICH Q3A para limites de impurezas. Fornece dados críticos para ensaios de liberação e validação de limpeza.
Referências
Mugnaini, Claudia, et al. “Synthesis of Pyrazolo[1, 5-a]Pyrimidine Ring as a Possible Bioisosteric Replacement of the 5-(1H-Pyrrol-1-Yl)Pyrazole Scaffold.â€Â Arkivoc, edited by Willem Arjen Lodewijk van Otterlo, vol. 2022, no. 2, Oct. 2021, https://doi.org/10.24820/ark.5550190.p011.628.
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