Abacavir EP Impurity D (sal de HCl) (CAS 267668-71-3) é uma impureza trans do abacavir que pode formar-se durante etapas de síntese | purificação ou armazenamento do princípio ativo; como sal di-hidroclorídrico | apresenta solubilidade e perfil de cristalização distintos que influenciam a extração e o controlo analítico. A sua monitorização exige métodos validados | tipicamente HPLC com deteção UV e confirmação por LC-MS e RMN | além de estudos de estabilidade e degradação forçados para identificar vias de formação. A caracterização completa | estabelecimento de limites aceitáveis e avaliação toxicológica são necessárias para suportar conformidade com monografias farmacopéicas e requisitos regulatórios.
Referências
Foster RH, Faulds D. Abacavir. Drugs. 1998 May;55(5):729-36; discussion 737-8. DOI: 10.2165/00003495-199855050-00018. PMID: 9585869. Kurmi, Moolchand, et al. “Stability Behaviour of Antiretroviral Drugs and Their Combinations. 5: Characterization of Novel Degradation Products of Abacavir Sulfate by Mass and Nuclear Magnetic Resonance Spectrometry.” Journal of Pharmaceutical and Biomedical Analysis, vol. 134, Feb. 2017, pp. 372–84, https://doi.org/10.1016/j.jpba.2016.10.019.
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