DETECTION OF BACTERIAL ENDOTOXINS IN DRUGS: DISTURBING FACTORS AND THEIR ELIMINATION

Introduction. It is important to ensure the absence of pyrogenic impurities in the manufacture of parenteral drugs. Control of pharmaceutical substances for bacterial endotoxins is a complex problem with the substances that are poorly water-soluble and/or have obstacles in carrying out the LAL test. Objective: to investigate the influence of the factors that may interfere with the detection of bacterial endotoxins via the gel-clot test, to search, and choose a method that eliminates the disturbing factors. Material and methods. The investigation objects were pharmaceutical substances, such as ascorbic acid and Teraftal, and blood drugs. The LAL-test in the modification of the gel-clot used tris-buffer (Tris-hydroxyethylaminomethyl hydrochloride), magnesium chloride solution, and the specific buffer β-glycan blocker. Results. Procedures were proposed to eliminate the factors interfering with the LAL-test. The most common causes of false results, such as inhibited gel formation due to a wrong pH value or the ability of substances to form complexes, were considered. A decision was proposed to prevent false-positive results in the index “Bacterial endotoxins” in experiments with blood preparations. Conclusion. Approaches to eliminating the influence of disturbing factors on the results of the LAL-test were elaborated.