Teste de endotoxina por Fator C recombinante para solução injetável de cloreto de sódio 0,9%
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Palavras-chave

Fator C Recombinante
Endotoxinas
Técnicas In Vitro
Solução Salina

Como Citar

1.
Hilinski E, Ghisleni DDM, Utescher CL de A, Quintilio W, Almodovar AAB, Bugno A, Pinto T de JA. Teste de endotoxina por Fator C recombinante para solução injetável de cloreto de sódio 0,9%. Rev Inst Adolfo Lutz [Internet]. 13º de junho de 2024 [citado 4º de dezembro de 2024];83:1-11,e40325. Disponível em: https://periodicos.saude.sp.gov.br/RIAL/article/view/40325

Resumo

A contaminação por endotoxinas é uma ameaça à segurança dos produtos farmacêuticos, especialmente dos medicamentos parenterais. Qualquer produto farmacêutico estéril e/ou livre de pirogênios requer especificações regulatórias para garantir a segurança de uso para o paciente. Este estudo abrange o estudo de avaliação de desempenho empregando o kit comercial Endozyme II® Go para quantificação de endotoxina, por Fator C recombinante (FCr), em amostras de cloreto de sódio 0,9% para uso parenteral. As amostras foram fortificadas com cinco concentrações distintas de soluções de endotoxina na faixa entre 0,0005 e 10 UE/mL. Cada um dos cinco níveis foi testado pelo menos cinco vezes para avaliação dos critérios de precisão, exatidão, limites de detecção e quantificação, linearidade e robustez. O desvio padrão relativo para os testes de precisão variou de 1,9 a 8,3%. Os valores de recuperação de endotoxina para o parâmetro exatidão estiveram compreendidos entre 61% e 125%. Os resultados demonstraram que o método por FCr permite a quantificação de endotoxinas com exatidão, precisão, especificidade e linearidade para a faixa de 0,005 e 10 UE/mL em amostras de cloreto de sódio 0,9% para uso parenteral.

https://doi.org/10.53393/rial.2024.v.83.40325
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Copyright (c) 2024 Ellen Hilinski, Daniela Dal Molim Ghisleni, Carla Lilian de Agostini Utescher, Wagner Quintilio , Adriana Aparecida Buzzo Almodovar , Adriana Bugno, Terezinha de Jesus Andreoli Pinto

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