A impureza Amoxicillin Related Compound 1 (HCl Salt) | CAS 127369-30-6 | é um composto relacionado identificado em lotes de amoxicilina como sal de cloridrato; ocorre por via de síntese ou degradação durante armazenamento. Caracteriza-se por propriedades físico-químicas distintas | solubilidade em água aumentada e perfil cromatográfico resolvível por HPLC reverso. Sua identificação e quantificação dependem de metodologias validadas como HPLC-UV e LC-MS/MS | com isolamento para confirmação por NMR. O controle analítico rigoroso | definição de limites de especificação e estudos de estabilidade são essenciais para mitigar riscos toxicológicos e assegurar conformidade com diretrizes regulatórias ICH relativas a impurezas.
Referências
Akhavan, Bobak J, and Praveen Vijhani. “Amoxicillin.†Nih.gov, StatPearls Publishing, 7 Mar. 2019, www.ncbi.nlm.nih.gov/books/NBK482250/.
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