Year: 2025
Type: article
Abstract: Introduction: Endotoxin contamination poses a significant risk to the safety of pharmaceutical products, particularly those administered parenterally. Ensuring patient safety requires strict adherence to the regulatory standards for sterile and pyrogen-free pharmaceutical formulations. Objective: This study aimed to evaluate the feasibility of using the Recombinant Factor C (rFC) method, specifically Endolisa®, for detecting bacterial endotoxins in hyperimmune sera (pentavalent antibothropic, anti-rabies, and tetanus antitoxin). Method: Samples were spiked with endotoxin solutions at concentrations ranging from 0.05 to 10 EU/mL and analyzed using the rFC kit. The key performance parameters were thoroughly evaluated, such as specificity, detection and quantification limits, precision, accuracy, and linearity. Each concentration was tested a minimum of five times across six points. Results: The method demonstrated precision with relative standard deviations ranging from 3.5% to 19.0%, accuracy for endotoxin recovery between 94.0% and 134.0%, and linearity across the concentration range of 0.05 to 5 EU/mL for the three sera. The detection and quantification limits were established at 0.05 EU/mL. Conclusions: The results confirm that the rFC method provides accurate, precise, specific, and linear quantification of endotoxins in hyperimmune sera within the range of 0.05 to 5 EU/mL at 1:100 dilution. However, for samples spiked with 10 EU/mL (1:100 dilution), the method did not meet the compendial criteria.
Source: Vigilância Sanitária em Debate
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W4415477751