Validación de la determinación de endotoxinas bacterianas por el método LAL en la solución estéril dextrosa al 5% en solución salina al 0.9% de la empresa Ginsberg Ecuador S.A.

Abstract

Limulus amebocyte lysate (LAL) analysis was used to determine the endotoxin bacterial validation, in the sterile solution 5% Dextrose in a 0.9% saline solution. The development of the research was applied in Ginsberg Ecuador S.A. Company located in Quito- Pichincha. In which three samples from each pilot batch were taken; which were selected from the beginning, middle and the end of production for each lot. With each of the samples it was possible to carry out a bulk, to obtain three sublots which have to be analyzed. LAL reagent sensitivity of 0.25 UE/mL was confirmed, and the analyst was graded to get reliable results. The limit of endotoxin for dextrose 5% in saline solution 0.9%, being equal to 10 UE/g, was taken from the pharma-record of the United States No 35, which allowed calculating the Maximum Dilution Valid (MVD) that was equal to 2.36; sequentially, testing procedure Spike and Unspike (preliminary) were conducted, and no interference was detected in the pharmaceutical product, so it was determined that the working dilution is 1: 2.36. Routine tests were developed, which allowed determining the bacterial endotoxins in each sublot previous mixture, obtaining a geometric average equal to 0.35, and a standard deviation of 0.18 < 0.365, this general data are within the limits described in the pharma-record of the United States No 35. It is concluded that Limulus amebocyte lysate about the determination of endotoxin bacterial is a validated to Quality Control of the sterile solution 5% Dextrose in a 0.9% saline solution, it is recommended to apply this method every six months to obtain reliable results in the detemination.