Impureza Sapropterin Inhouse Impurity C | também denominada Biopterin e registrada sob CAS 22150-76-1 | é um degradante relevante identificado no processo de síntese e no armazenamento da sapropterina. A sua detecção e quantificação são críticas como atributo de qualidade | exigindo caracterização por HPLC com detecção UV e por LC-MS para confirmação da massa | além de NMR para elucidação estrutural. Estudos de estabilidade avaliam vias de degradação e condições que favorecem a sua formação. Dados de solubilidade | ponto de fusão e comportamento cromatográfico orientam o desenvolvimento de métodos analíticos robustos e estabelecimento de limites de aceitação.
Referências
Qu, Jinghan, et al. “Efficacy and Safety of Sapropterin Dihydrochloride in Patients with Phenylketonuria: A Meta-Analysis of Randomized Controlled Trials.†British Journal of Clinical Pharmacology, vol. 85, no. 5, Mar. 2019, pp. 893–99, https://doi.org/10.1111/bcp.13886. ?
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