Valproic Acid EP Impurity J (CAS 5340-48-7) é uma impureza alifática carboxílica de cadeia curta associada ao ácido valpróico | caracterizada por elevada polaridade relativa e ponto de ebulição moderado. Quimicamente semelhante ao n-pentanoico | apresenta solubilidade em solventes orgânicos e água limitada; sua detecção exige técnicas sensíveis como HPLC com detecção por MS | GC-MS após derivatização e RMN para confirmação estrutural. Presente por degradação térmica ou reações secundárias durante síntese | esta impureza impacta o perfil de pureza | estabilidade e conformidade com Farmacopeia Europeia; o controle analítico e limites especificados são essenciais para garantia de qualidade e segurança do lote.
Referências
Alsarra, Ibrahim A., et al. “Valproic Acid and Sodium Valproate: Comprehensive Profile.” Profiles of Drug Substances, Excipients and Related Methodology, 2005, pp. 209–40, https://doi.org/10.1016/s0099-5428(05)32008-9. Zgouras, Dimitrios, et al. “Modulation of Angiogenesis-Related Protein Synthesis by Valproic Acid.” Biochemical and Biophysical Research Communications, vol. 316, no. 3, Apr. 2004, pp. 693–97, https://doi.org/10.1016/j.bbrc.2004.02.105.
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