Keywords
Endotoxins
In Vitro Test
Saline Solution
How to Cite
Abstract
Endotoxin contamination is a threat to the safety of pharmaceutical products, especially parenteral drugs. Any sterile and/or pyrogen-free pharmaceutical product requires regulatory specifications to ensure safe patient use. This study covers theperformance evaluation study of an endotoxinquantitat ion commercial kit by recombinant Factor C (rFC),Endozyme II® Go, for 0.9% sodium chloride injection. The samples were spiked with endotoxin solutions between 0.0005 and 10 EU/mL and tested by the rFC kit to evaluate precision, accuracy, detection and quantification limits, linearity, and robustness. Each of the six points was assayed at least five times. The relative standard deviation for precision testing ranged from 1.9 to 8.3%. The recovery accuracy values of endotoxin were between 61% and 125% for the range from 0.005 to 10 EU/mL. The results demonstrated that the rFC method allows endotoxin quantification with accuracy, precision, specificity, and linearity for the range of 0.005 and 10 EU/mL for 0.9% sodium chloride injection.
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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