A Impureza EP G de amlodipino, também designada Amlodipine Related Compound C, é uma impureza de प्रक्रिया definida e relacionada ao processo do bloqueador dos canais de cálcio diidropiridínico amlodipino. Com CAS 43067-01-2, fórmula molecular C17H18ClNO4 e massa molecular de 335,78 g/mol, corresponde a um derivado clorado de piridina compatível com arraste de intermediário de síntese ou formação de subproduto durante etapas de construção heterocíclica e esterificação. Sua determinação normalmente exige LC-MS/MS para perfis em nível de traço, com HPLC-UV para resolução cromatográfica e ensaio de impurezas. Não se trata de uma nitrosamina, mas permanece relevante para qualificação de impurezas segundo parâmetros farmacopeicos e orientações ICH.
Referências
Ananchenko, Gennady, et al. Amlodipine Besylate.†Profiles of Drug Substances, Excipients and Related Methodology, 2012, pp. 31–77, https://doi.org/10.1016/b978-0-12-397220-0.00002-7.?
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