RT Journal Article
SR Electronic
T1 Variability in the LAL Test: Comparison of Three Kinetic Methods for the Testing of Pharmaceutical Products
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 69
OP 72
VO 46
IS 3
A1 Karen Zink Mccullough
A1 Cindy Weidner–Loeven
YR 1992
UL http://journal.pda.org/content/46/3/69.abstract
AB Data presented in this study indicate that there is considerable variability in spike recoveries between three different kinetic LAL methods as used for the testing of a variety of parenteral products. However, successful spike recoveries were observed for each of the thirteen products under test on at least one of the three kinetic methods used, suggesting that problems caused by spike recovery variability may be easily controlled in the laboratory by flexibility in the choice of method.