Resumo

PERDOMO MORALES, Rolando  e  MONTERO ALEJO, Vivian. Estandarización del ensayo del lisado de amebocitos de Limulus (LAL):: método de gelificación. Rev Cubana Farm [online]. 2004, vol.38, n.1, pp. 1-1. ISSN 1561-2988.

The control of endotoxins in the final product of parenteral drugs is among the main applications of the limulus amebocyte lysate (LAL). For the successful application of this test, it is necessary to have a thorough knowledge of a series of abilities. That's why, it is usually made at specialized laboratories having a vast experience. In spite of the fact that it is already a widely established and known method, the application of the assay may be laborious, take time and consume reagents until the obtention of the right results. In the present paper, it is described the standardization of the LAL assay by the gelification method. Various strategies are evaluated in order to optimize and/or reduce the total time of the assay, the use of materials as certified endotoxin-free points, test tubes, and the substitution of endotoxin-free water, supplied by the manufacturers of LAL reagent, by injection water. The standardized procedure produces valid results according to the criteria of the U.S. Pharmacopoeia

Palavras-chave : LAL method; endotoxins; pyrogens; quality control; injections.