Arginina EP Impurity B (CAS 372-75-8) é uma impureza polar e hidrossolúvel observada em lotes de L-arginina descrita também por sinônimos como citrulina | Delta-ureidonorvalina | N5-(aminocarbonyl)-L-ornitina e N5-carbamoyl-L-ornitina. Estruturalmente caracterizada pela presença de um grupo carbamoíla ligado a um resíduo aminoácido | esta impureza altera o perfil cromatográfico e requer identificação e quantificação rigorosas por HPLC com detecção por espectrometria de massas | cromatografia iônica e RMN. A sua monitorização é crítica para conformidade com especificações da Farmacopeia Europeia | investigação de origem durante síntese e purificação e avaliação de possíveis impactos na segurança e estabilidade do produto.
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