Valproic Acid EP Impurity A (CAS 109-52-4) | também conhecida como ácido valérico ou n-valeric acid | é uma impureza relevante no controle de qualidade do ácido valproico. Quimicamente um ácido carboxílico de cadeia linear | sua presença em níveis superiores aos limites monografados pode indicar degradação do princípio ativo ou falhas no processo de síntese. Caracteriza-se por polaridade e solubilidade em solventes orgânicos | detectável por HPLC com detecção UV | GC-MS e RMN para confirmação estrutural. O monitoramento quantitativo e a validação de métodos analíticos são essenciais para garantir conformidade com limites estabelecidos e minimizar riscos de estabilidade e segurança do produto final.
Referências
Reddy, S. Raghavender, et al. “Reliable GC Method for Related Substances in Divalproex Sodium Drug.” Journal of Chromatographic Science, vol. 55, no. 9, July 2017, pp. 891–98, https://doi.org/10.1093/chromsci/bmx057. ?
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