Limulus-Amöbozyten-Lysat-Test zum Nachweis von Endotoxinen in öligen Formulierungen
Andreas Schlösser, Lothar Bomblies, Labor L+S AG, Bad Bocklet
Korrespondenz: Dr. Andreas Schlösser, Labor L+S AG, Mangelsfeld 4, 97708 Bad Bocklet (Germany),
Limulus Amoebocyte Lysate Test for the Detection of Endotoxins in oily Formulations / Extraction of bacterial Endotoxins from oily parenterals by means of a shake-out extraction method
The verification of the absence of pyrogens along with sterility testing during the production of parenteralia are essential parameters for the release of pharmaceutical finished products. Bacterial endotoxins, the most common class of pyrogens are detected with the Limulus Amoebocyte Lysate (LAL) test in aqueous solutions. Using an extraction method with pyrogen-free water, bacterial endotoxins were extracted quantitatively from artificially contaminated oil into water for the bacterial endotoxin test. Thus oily formulations can be tested for endotoxin contamination with the aid of the LAL test.
Key words Ausschüttelverfahren • Endotoxine • Limulus-Amöbozyten-Lysat • Parenteralia, ölige • Spike