Impureza Isopropanol-Rosuvastatin é uma impureza relacionada observada durante a síntese e purificação da rosuvastatina, resultante de adição ou incorporação de solvente isopropanol ao intermediário ativo. Caracteriza-se por deslocamento no tempo de retenção em HPLC, sinal diagnóstico em LC-MS correspondente ao [M+H]+ esperado e padrões de deslocamento em espectros NMR que indicam grupo isopropil. Pode afetar potência e perfil de segurança se acima de limites especificados. Estratégias de controle incluem otimização de lavagem, remoção de solvente residual por evaporação e validação de métodos analíticos de quantificação por HPLC com limites de aceitação conforme diretrizes regulatórias. Estudos de estabilidade definem sua formação sob condições de umidade e temperatura.
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