3alpha-Hydroxy Pravastatin Lactone-D3 (CAS 1329809-35-9) é uma impureza isotopicamente marcada caracterizada pela presença do anel lactona e um grupo hidroxila na posição 3alpha, com três átomos de deutério incorporados, conferindo deslocamento de massa observável por espectrometria de massas. Pode originar‑se por reações secundárias durante a síntese ou por ciclização/hidrólise da forma ácida, exibindo maior polaridade e retenção reduzida em cromatografias reversas. A sua identificação e quantificação exigem métodos LC‑MS/MS sensíveis, confirmação por RMN e avaliação de estabilidade frente a pH e temperatura. Deve ser monitorada e controlada segundo diretrizes de impurezas para garantir qualidade e consistência do material.
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