Sapropterin Inhouse Impurity G (CAS 100-63-0) | conhecida também como fenilhidrazina | é uma impureza orgânica relevante por sua reatividade do grupo hidrazina e potencial impacto na qualidade do produto final. Caracteriza-se por baixa massa molar | alta reatividade nucleofílica e sensibilidade à oxidação | exigindo monitorização sensível por HPLC acoplada a detectores UV e espectrometria de massas (LC-MS/MS ou GC-MS) para quantificação e identificação estrutural. A presença pode indicar vias de degradação ou reações secundárias durante síntese e purificação; portanto limites aceitáveis | estudos de estabilidade forçados e controles de processo são recomendados para mitigação e conformidade regulatória.
Referências
Muntau, Ania C., et al. “Long-Term Efficacy and Safety of Sapropterin in Patients Who Initiated Sapropterin at < 4 Years of Age with Phenylketonuria: Results of the 3-Year Extension of the SPARK Open-Label, Multicentre, Randomised Phase IIIb Trial.†Orphanet Journal of Rare Diseases, vol. 16, no. 1, Aug. 2021, https://doi.org/10.1186/s13023-021-01968-1. ?
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