Resumen

MONTANO E, Dolly E; ALVARADO R, Moisés G  y  BURGOS Q, Maritza J. Method validation clot formation for determining bacterial endotoxins national immunoglobulin (IgG). INHRR [online]. 2016, vol.47, n.1-2, pp.76-94. ISSN 0798-0477.

Bacterial endotoxins are lipopolysaccharides (LPS) located exclusively in the outer membrane of gram-negative bacteria, their entry into the body through parenteral products can cause fever, tachycardia, increased blood pressure and in some cases cause death. There are international standards for endotoxin limit for injectable pharmaceuticals, such as immunoglobulins (IgG), which may be exposed to contamination during the production process and therefore it is necessary to test for determination of bacterial endotoxins. The method of the Limulus amebocyte lysate (LAL) is one of them. This method is based on the LAL reaction, which is an extract of blood cells which interact with endotoxin, triggering the cascade of the coagulation process and causing the formation of coagulin. On several occasions some proteins involved in the activation or deactivation of this waterfall, either by enhancing or inhibiting clot formation. In the case of empowerment, the warming is one of those recommended by the US Pharmacopoeia (USP) to eliminate interference, since denatures proteins that cause endotoxin enhancement lossless methods. In this paper the determination of bacterial endotoxins in IgG was standardized by the LAL method, which is quick and easy to implement method, which can be implemented as a routine test in quality control and thus allows us to streamline releases Lots of these products.

Palabras clave : Bacterial endotoxins; Limulus amoeboid lysate (LAL); Immunoglobulin G (IgG); Lipopolysaccharides; Reaction potentiation; Interference in reaction.