TY - JOUR T1 - The Significance of Limulus Amebocyte Lysate Test Specificity on the Pyrogen Evaluation of Parenteral Drugs JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 103 LP - 108 VL - 34 IS - 2 AU - Frederick C. Pearson AU - Marlys Weary Y1 - 1980/03/01 UR - http://journal.pda.org/content/34/2/103.abstract N2 - Although the sensitivity of the Limulus Amebocyte Lysate (LAL) Test for gram-negative endotoxin is well established, several reports have appeared in the literature indicating that substances other than endotoxin can elicit positive LAL test reactions under certain conditions. This discussion of LAL test specificity deals with the impact these findings could have on the use of LAL for pyrogen testing in the parenteral drug industry, and concludes that false positive LAL test reactions due to substances other than endotoxin need not concern most parenteral drug manufacturers. These, however, can be ruled out by using appropriate controls. ER -