Desarrollo y validación de la prueba de endotoxinas bacterianas LAL (límulus Amebocyte lysate) por el método Gel-Clot en la solución inyectable de Hialuronato de sodio ALURONIC BLISPACK de Gisberg Ecuador S.A.

Abstract

The validation of the LAL (Limulus Amebocyte lysate) bacterial endotoxin test was performed by the GEL-CLOT gelation method, using the injectable solution of ALURONIC Blispack sodium hyaluronate, a process that was developed in the microbiological laboratory of the quality control department of the pharmaceutical industry GINSBERG S.A. in the city of Quito, province of Pichincha, to be applied in future analyses of the product. A validation protocol was elaborated based on the official methodology of bacterial endotoxin tests given by the United States Pharmacopoeia, edition 35, preliminary and validation tests were carried out, with a random sampling of three pilot lots of ALURONIC Blispack, the verification of the optimum pH of the sample, a verification test of the LAL reagent that was developed in parallel with the analyst's validation, calculation of the maximum dilution value, tests of inhibition, interference or enhancement factors and the coagulation limit test determining that the sample does not present more than 0. 25 units of bacterial endotoxins per ml of sodium hyaluronate. According to the results obtained, it is concluded that the product is free of bacterial endotoxins and that it is suitable for its administration in patients who require it and that the methodology mentioned above is validated. It is recommended the application of this process in future analyses of the product within the pharmaceutical industry and possible revalidations of the product.