Milrinone Impurity 14 (HCl Salt) é uma impureza derivada do processo sintético ou de degradação do sal hidroclorídrico de milrinona que requer monitoramento rigoroso em controle de qualidade; caracteriza-se por propriedades físico-químicas específicas que influenciam estabilidade e perfil de pureza do lote | sendo identificada e quantificada por métodos validados como HPLC com método indicador de estabilidade | LC-MS para determinação da massa molecular e NMR para confirmação estrutural; sua presença pode demandar ações de purificação e investigação de origem conforme diretrizes regulatórias ICH sobre impurezas | incluindo estudos de degradação forçada e limites de especificação robustos.
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