Naphazoline EP Impurity C (CAS 132-75-2) é uma impureza identificada no perfil de Naphazoline conforme monografias europeias. Esta entidade apresenta propriedades físico-químicas e espectrais que a distinguem do princípio ativo | exigindo quantificação por cromatografia líquida de alta eficiência com detecção UV e confirmação por espectrometria de massas. A presença desta impureza acima dos limites especificados pode afetar pureza | estabilidade e segurança do lote | sendo necessária validação de métodos analíticos | estabelecimento de limites de especiação e procedimentos de controle de processo para redução. Relatórios de investigação de desvios e documentação de avaliação toxicológica são recomendados para conformidade regulatória.
Referências
LAHIRI, V. N. “Report on the Structure of Carbazole, C12H9N.†Zeitschrift Für Kristallographie – Crystalline Materials, vol. 127, no. 1-6, Dec. 1968, pp. 456–59, https://doi.org/10.1524/zkri.1968.127.16.456.?“Simultaneous Determination of Naphazoline Nitrate and Tetramethylthionine Base in Eye Drops by First-Derivative UV Spectrophotometry.†Taylor & Francis, 2021, www.tandfonline.com/doi/abs/10.1080/00032719908542826.?
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