RT Journal Article
SR Electronic
T1 The Impact of Non–endotoxin LAL–Reactive Materials on Limulus Amebocyte Lysate Analyses
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 2
OP 6
VO 51
IS 1
A1 James F. Cooper
A1 Marlys E. Weary
A1 Foster T. Jordan
YR 1997
UL http://journal.pda.org/content/51/1/2.abstract
AB Limulus amebocyte lysate (LAL) is activated by bacterial endotoxins and certain glucans (β’D’glucan, LAL’RM). The potential for conflicting inter’laboratory results for LAL tests exists because commercial LAL reagents are highly variable in response to LAL’reactive glucans. The nature of β’D’glucan activation of LAL and means for rendering LAL non’responsive to glucan are reviewed to provide a background for resolving conflicting data. Kinetic LAL methods are particularly useful for screening materials potentially contaminated with glucan. The presence of β’D’glucan in parenterals is uncommon and is likely limited to products exposed to microbial or cellulosic materials. A scheme is suggested for identifying LAL’reactive glucans and for LAL release’testing without glucan interference.