Impureza Rosuvastatina (3R | 5S)-Isómero Éster Metílico é um subproduto estereoespecífico gerado durante etapas de esterificação e racemização parcial na síntese da molécula base. Possui massa molecular e polaridade próximas ao fármaco ativo | exigindo métodos cromatográficos de alta resolução como HPLC com detecção por UV e espectrometria de massas tandem para separação e quantificação confiável. A caracterização estrutural por RMN e análise de pureza por chiral HPLC esclarecem sua configuração (3R | 5S) e potenciais impurezas relacionadas. Controle abrangente inclui otimização de condições reacionais | etapa de purificação adicional e critérios de aceitação alinhados a risco toxicológico e estabilidade para garantir conformidade do produto final.
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