RT Journal Article
SR Electronic
T1 Collaborative Study of a Control Standard Endotoxin Using the Limulus Amebocyte (Gel-Clot) Test
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 88
OP 93
VO 45
IS 2
A1 Adner, Niklas
A1 Flinik, Ola
A1 Nystrand, Rolf
A1 Pihl, Berthil
A1 Vegis, Peter
YR 1991
UL http://journal.pda.org/content/45/2/88.abstract
AB A collaborative study was undertaken to determine the potency in endotoxin Units (EU) and International Units (IU) of a control standard endotoxin, LIF-1. Five laboratories from the Swedish Pharmaceutical Industry participated in the study. As reference preparations, two official standards, USP reference standard endotoxin, EC-5 (expressed in EU) and WHOs international standard endotoxin (expressed in IU),were used. The study was performed using the Limulus Amebocyte Lysate (LAL), gel-clot test. The test protocol included dilutions of the endotoxin in steps of 1:1.25 instead of the conventional 1:2 step dilution method. This gave more precise and standardized results. The content of one vial of LIF-1 (CSE) was calculated to be 22 EU and 16IUwhich indicates that I EU (USP) corresponds to 0.7 IU (WHO).