Informações adicionais sobre o Rosuvastatin 3S 5S isomer
Fármaco de origem
Rosuvastatin
Nome IUPAC
(3S, 5S, 6E)-7-[4-(4-fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3, 5-dihydroxyhept-6-enoic acid Calcium salt
Sinônimos
N/A
Descrição
Rosuvastatina 3S 5S isômero é uma impureza estereoquímica relevante no desenvolvimento e controlo de qualidade de produtos à base de rosuvastatina. A presença deste isômero pode alterar o perfil farmacológico e implicar riscos toxicológicos e por isso exige identificação e quantificação robustas. Métodos validados de análise | incluindo cromatografia líquida quiral | HPLC-MS e RMN | são usados para caracterizar pureza | perfil de impurezas e cinética de formação durante síntese e armazenamento. Estratégias de controlo compreendem limites especificados | ensaios de estabilidade acelerada | investigação de vias de degradação e medidas de mitigação no processo produtivo para garantir conformidade com requisitos regulatórios.
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