RT Journal Article
SR Electronic
T1 Effect of Nonsterility on the Activity of Limulus Amebocyte Lysate
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 196
OP 200
VO 36
IS 5
A1 Frederick C. Pearson
A1 John Dubczak
A1 Cathy Nakashima
A1 David F. Carpenter
YR 1982
UL http://journal.pda.org/content/36/5/196.abstract
AB Lyophilized Limulus amebocyte lysate(LAV) was reconstituted with magnesium chloride inoculated with from 102 to I06 organisms of one of 10 different microorganisms, per milliliter to ascertain whether nonsterility would affect the lysate’s performance. The organisms used included Gram-positive and Gram-negative bacteria, yeasts, and molds. A concentration of 1O4 organisms of the Gram-negative bacteria per milliliter produced a positive LAL reaction; only one Gram-positive bacteria (B. subtilis) produced a positive response, and this only at the highest concentration (1O6 org/ml). A positive response was also observed with the highest concentrations of yeasts and molds. Because these levels are higher than those that would normally be encountered, it was concluded that nonsterility did not significantly affect the performance of LAL.