Resumen

OSORIO ROJAS, Olga et al. Interferences in the validation of the Limulus amebocyte lysate for oxytetracyline 50 mg/mL. Rev Cubana Farm [online]. 2007, vol.41, n.1. ISSN 0034-7515.

The endotoxin analysis by the Limulus amebocyte lysate (LAL) assay is one of the main tests in the quality control of the manufacture of injectables due to their repercussion on human and animal health. That's why the validation of the technique is required for parenteral products. The LAL gel-clot method was used to validate the detection of bacterial endotoxin in the oxytetracycline produced by a veterinary pharmaceutical laboratory of Bogota-Colombia. To this end, samples were taken at the beginning, interval and end of 3 different batches of the medicine and the test of validation was made just as it is specified in the United States Pharmacopea XXV. The results for the Maximum Valid Dilution of the product (1:80) of the Spike test showed a 100 % of inhibition until dilution 1:16, and 0 % of inhibition in the following dilutions. In the Unspike test, it is seen an enhancement of the test from dilution 1:32. The label for a reagent of LAL with sensitivity (l) of 0.25 UE/mL and the operator who made the test made were validated.

Palabras clave : Endotoxin; Limulus Amebocyte Lysate (LAL),; maximum valid dilution; Spike; Unspike; validation.