Abstract

PERDOMO MORALES, Rolando  and  MONTERO ALEJO, Vivian. Validación de un ciclo de despirogenización por calor seco con el empleo del ensayo del lisado de amebocitos de limulus. Rev Cubana Farm [online]. 2003, vol.37, n.3, pp. 1-1. ISSN 1561-2988.

To fullfill the good laboratory and parenteral drugs manufacturing practices, one of the demands is the validation of the depyrogenation cycles that are used. In this paper, it is described the validation of a depyrogenation cycle by dry heat in a convection oven. The physical features of the equipment, such as the time required to reach the established temperature, its distribution, stability, and the influence of the charge on the heating pattern, were studied in the first stage. Taking into account the results of this phase, it was established a total process of 7 h at 180 °C. The second stage consisted in the determination of the degreee of depyrogenation, challenging the process with endotoxin bioindicators. The concentration of biotoxins in the control bioindicators, which were subjected to the depyrogenation process, was quantified by using the limulus amoebocytes flattening by gelification method.. The difference between the content of endotoxins in the control and the treatments was 2 400 U of endotoxins. That's why, the process yielded a minimum logarithmic reduction of 4.6 log that is higher that the limit of 3 log established by the US Pharmacopoeia.

Keywords : ENDOTOXINS; DENSITY FACTOR; LIMULUS TEST.