Abstract

BURGUET LAGO, Nancy; REYES TUR, María Isabel; BRITO GODOY, Lázaro C  and  TROCHE CONCEPCION, Yenilen. Assessment of bacterial endotoxins in Zoledronic acid injectable drug by using Limulus amebocyte lysate test. Rev Cubana Farm [online]. 2012, vol.46, n.3, pp. 320-328. ISSN 0034-7515.

Objective: To asses the presence of bacterial endotoxins in Zoledronic Acid injectable drug by using the Limulus amebocyte lysate test, particularly by the gelling procedure. Methods: The assay was performed in two tests: the first was the confirmation of labeled lysate sensitivity by preparing a standard curve with serial double dilutions of endotoxins four times, and the second was the inhibition product test in which serial double dilutions of endotoxins were prepared with apyrogenic water and with samples from the batches to be tested, without exceeding the maximum valid dilution. The end point was determined and the geometric mean was calculated. Working dilution was defined and then validated four times in three consecutive batches. Results: The lysate sensitivity was 0.03125 EU/mL). The maximum valid dilution and the working dilution were 112 EU/mL and 1/100 EU/mL) respectively. The amount of bacterial endotoxins present in three batches of the injectable drug did not exceed the set limit, so it complied with the quality specifications for this test. Conclusions: The standardization of the gelling method conditions makes it possible to state that this method is effective, reliable, quick and easy-to-perform, so it can be used as a regular test in the quality control of the analyzed parenteral drug.

Keywords : Bacterial endotoxins; gelling; maximum valid dilution; Limulus amebocyte lysate.

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