Informações adicionais sobre o Ampicillin EP Impurity L
Fármaco de origem
Amoxicillin
Nome IUPAC
(2R)-2-amino-2-phenylacetic acid
Sinônimos
D-Phenylglycine
Descrição
Ampicillin EP Impurity L | identificada também como D-Phenylglycine | é uma impureza de síntese relevante para o controle de qualidade de ampicilina conforme Farmacopeia Europeia. Apresenta características analíticas detectáveis por HPLC com detecção UV | confirmação por espectrometria de massa e análise estrutural por RMN. Pode originar-se de reações secundárias durante a etapa de acilação e requer monitorização por limites de aceitação e testes de estabilidade para avaliar sua formação ao longo do armazenamento. Suas propriedades físico-químicas | solubilidade e perfil de degradação influenciam a pureza do medicamento e orientam estratégias de purificação e validação de métodos analíticos.
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