PT  - JOURNAL ARTICLE
AU  - Adner, Niklas
AU  - Flinik, Ola
AU  - Nystrand, Rolf
AU  - Pihl, Berthil
AU  - Vegis, Peter
TI  - Collaborative Study of a Control Standard Endotoxin Using the Limulus Amebocyte (Gel-Clot) Test
DP  - 1991 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 88--93
VI  - 45
IP  - 2
4099  - http://journal.pda.org/content/45/2/88.short
4100  - http://journal.pda.org/content/45/2/88.full
SO  - PDA J Pharm Sci Technol1991 Mar 01; 45
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).