Evaluation of the cromogenetic kinetic methodto determinate bacteria endotoxins in the infant injectable succinylcholine 100 mg.

Abstract

The aim of this study was to evaluate the method of the Limulus amebocyte lysate (LAL) in its kinetic chromogenic variant for the determination of bacterial endotoxins in infant succinylcholine injection 100 mg. This variant do a monitoring of the color development across time and uses a standard curve plotted for the reaction time according to the known endotoxin, in the range of 0.005 to 50 EU / mL concentration. The rating analyst for reliable results was confirmed by the standardization of the method. It was carried out the characterization of the product being obtained 1:8000 as dilution factor when calculating the maximum valid dilution. The selection of the working dilution was evaluated in preliminary inhibition and enhancement testing and 1:4000 have being defined as the optimal dilution. The chosen dilution was validated in three consecutive batches of the product and the percentages observed in all cases recovered framed in the limits (50-200%) and lower coefficient of approved acceptance criteria for this parameter variation. The method was applied to the three pilot batches. In the conclusion we can state that it was shown that this standardization and validation allow its application as a routine test for determination of bacterial endotoxins as part of the quality control and stability study of this product.