Browsing by Author "Naranjo Chamorro, Adriana Marcela"
Now showing 1 - 1 of 1
Results Per Page
Sort Options
Item Evaluación de la presencia de factores de interferencia en agua estéril para inyección mediante la técnica Gel-Clot en Laboratorios EDO S.A.S(Universidad Santiago de Cali, 2025-12-05) Naranjo Chamorro, Adriana Marcela; Velez Salazar, Andrea; Martínez Garay, Carlos Andrés (Director); Cruz Bolaños, Yimy William (Director)The microbiological safety of parenteral products is essential to ensure their safety, as bacterial endotoxins pose a critical health risk. These toxins, components of the outer membrane of Gram-negative bacteria, can cause fever, septic shock, or death, and are not always eliminated by conventional sterilization processes. In order to verify the quality of the “Sterile Water for Injection” produced by Laboratorios EDO S.A.S., the presence of possible interference factors in the detection of endotoxins was evaluated using the Gel-Clot technique described in USP <85>, using LAL reagent and positive and negative controls. The results demonstrated the absence of endotoxins and confirmed that there were no inhibitory or enhancing effects that affected the sensitivity of the assay. It is concluded that the analyzed water complies with pharmacopoeial specifications and is suitable for the manufacture of sterile drugs, supporting good manufacturing practices.