A impureza Methylprednisolone 21-propionato (CAS 138804-88-3) é um degradante relacionado identificado durante controle de qualidade de esteroides; apresenta similaridade estrutural ao princípio ativo e pode afetar potência e perfil de segurança do lote. Caracterização por HPLC | LC-MS e espectroscopia NMR define seu tempo de retenção | massa molecular e sinais característicos. Estudos de estabilidade indicam formação por esterificação ou transesterificação sob condições ácidas ou alcoólicas. Limites de especificação | análise por método validado e estratégias de controle no processo | incluindo otimização de etapas de purificação e testes de limpeza | são recomendados para mitigação do risco.
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