Impureza: sal tri-sódico do dímero da amoxicilina (forma de ácido penicilóico) | mistura de diastereómeros (CAS 210289-72-8) é um subproduto de degradação crítico em controles de qualidade de amoxicilina. Esta impureza reflete dimerização e abertura do anel betalactâmico | com impacto direto na pureza | potência e estabilidade da substância ativa. A sua identificação e quantificação exigem métodos analíticos robustos como HPLC com detecção UV | LC-MS e RMN para caracterização de diastereómeros e massas. Materiais de referência com este composto suportam desenvolvimento e validação de métodos | definição de limites de especificação e investigação de vias de degradação.
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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