PT  - JOURNAL ARTICLE
AU  - Christine W. Twohy
AU  - Mark L. Nierman
AU  - Anthony P. Ouran
AU  - Terry E. Munson
TI  - Comparison of Limulus Amebocyte Lysates from Different Manufacturers
DP  - 1983 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 93--96
VI  - 37
IP  - 3
4099  - http://journal.pda.org/content/37/3/93.short
4100  - http://journal.pda.org/content/37/3/93.full
SO  - PDA J Pharm Sci Technol1983 May 01; 37
AB  - The variability of product compatibility and inhibition endpoints with commercially available limulus amebocyte lysate (LAL) reagents was determined by testing nine different drug products with three lots ofLALfrom each of four manufacturers and one lot from a fifth manufacturer. Only LAL reagents designed for the gel-clot method were used in this study; EC-5 was used as the endotoxin standard. Endpoints for three of the nine drug products were within a twofold dilution among the LAL reagents, two drug products were compatible in only two of five LAL reagents, and endpoints of the remaining four drug products varied among the five LAL reagents. Some of the drug products tested varied from lot-to-lot with LAL reagents from two manufacturers. With two of the LAL reagents, the pH of one drug product affected its compatibility. LAL reagents also varied in their ability to change the pH of drug product/LAL combinations. These results emphasized the need to revalidate the LAL test for each drug product when LAL manufacturers and/or LAL reagent lots are changed.