Rivaroxaban Open-Ring Acid (HCl) | CAS 931117-61-2 | é uma impureza de anel aberto do princípio ativo que aparece como sal cloridrato durante a síntese ou degradação. Trata-se de uma entidade polar com maior solubilidade em água que o composto alvo | exigindo métodos analíticos sensíveis como HPLC acoplado a espectrometria de massas para identificação e quantificação. Sua presença pode afetar o perfil de pureza | estabilidade e ensaios de potência | portanto limites e especificações devem ser estabelecidos. Estratégias de controle incluem otimização de etapas de síntese | purificação por cristalização e validação de métodos analíticos para garantir conformidade com boas práticas de fabricação.
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