Impureza cíclica fluorofenila do atorvastatina, na forma de sal de potássio, é um subproduto de ciclização do anel fluorofenila identificado no perfil de impurezas do API. Esta espécie iônica apresenta maior polaridade e solubilidade aquosa relativa, exigindo métodos analíticos sensíveis como HPLC reverso com detecção UV e LC-MS para quantificação e identificação estrutural, complementados por RMN 1H/13C e espectrometria de massas. A sua formação é favorecida por condições ácidas e térmicas durante síntese e armazenamento, podendo comprometer pureza, cristalografia e estabilidade do lote. Estratégias de controle incluem limites especificados, ensaios de indicação de estabilidade e etapas de purificação direcionadas.
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