A Impureza Salbutamol EP Impurity M (Formate Salt) é um composto relacionado frequentemente monitorado em estudos de pureza e controle de qualidade de salbutamol | também referida como Salbutamol BP Impurity M (Formate Salt) e Levalbuterol Related Compound C (Formate Salt). Esta impureza pode originar-se de reações de formação de sal com ácido fórmico ou de degradação durante síntese e armazenamento. A sua caracterização analítica recorre tipicamente a HPLC com detecção UV | LC-MS e RMN para identificação estrutural e quantificação dentro de especificações validadas em conformidade com as diretrizes ICH. O monitoramento sistemático permite avaliar estabilidade do produto e implicações toxicológicas potenciais.
Referências
Lavorini, Federico, et al. Clinical and Functional Responses to Salbutamol Inhaled via Different Devices in Asthmatic Patients with Induced Bronchoconstriction.†British Journal of Clinical Pharmacology, vol. 58, no. 5, Nov. 2004, pp. 512–20, https://doi.org/10.1111/j.1365-2125.2004.02185.x.
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