O aduto de ribose de pramipexol (mistura de diastereômeros) é uma impureza formada por glicação do núcleo aminotiazólico durante síntese ou armazenamento | gerando isômeros estereogênicos de propriedades físico-químicas distintas. Sua presença complica a caracterização analítica e exige métodos robustos como HPLC com resolução de diastereômeros | LC-MS para massa e RMN para atribuição estrutural. Controlar pH | tempo de reação e condições de secagem reduz sua formação | enquanto estudos de estabilidade e testes de forçamento avaliam seu impacto na qualidade do lote. Definição de limites | validação de método e monitorização no controle de qualidade são essenciais para garantir conformidade regulatória.
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