Data presented in this study indicate that there is considerable variability in spike recoveries
between th~ ee different_ kinetic LAL methods as used for the testing of a variety of …

One of the most difficult problems facing the LAL user is assessing the variability of the test"
in our/my hands." I have taken some common sources of variability and divided them into …

While every effort has been made by the publisher and the author to ensure the accuracy of
the information expressed in this book, the organization accepts no responsibility for errors …

… Karen Zink McCullough is principal consultant at MMI Associates, a consulting firm
focusing on Quality System development and pharmaceutical microbiology. Ms McCullough is …

Analysts working on Bacterial Endotoxins Test (BET) method development are often presented
with new compounds or new products, and are asked to calculate an endotoxin limit, …

The initial studies of the “LER” phenomenon describe a sudden and irreversible loss of “endotoxin
activity” when Control Standard Endotoxin (CSE), in the form of chemically extracted …

We’ve all heard the expression,“the error of the gel clot test is one two-fold dilution.” This
assumption describes the range of 50-200% of nominal value of label claim or PPC in a kinetic …

The fifteenth anniversary of American Pharmaceutical Review prompted my reflection on
the 40+ years of evolution of the Limulus Amebocyte Lysate (LAL) test in our industry. This …

Why is a chapter on the bacterial endotoxin test (BET) included in a book on environmental
monitoring? Because endotoxins, which are potent pyrogens, or fever causing agents, are by-…

The use of Limulus amebocyte lysate (LAL) to detect and control the presence of pyrogenic
substances in pharmaceuticals and medical devices is a relatively recent development. …