Prior to testing for the presence of bacterial endotoxin, parenteral products are handled and
stored in a variety of ways. Two incidents, detected by the US Food and Drug Administration …

From January 1980 to October 1983, the Food and Drug Administration (FDA) examined
2526 samples, including 333 different drug products, by the limulus amebocyte lysate (LAL) …

For release of parenteral drug products, bacterial endotoxin testing is one of a panel of
necessary tests. In order to ensure the validity of such tests, various controls are performed …

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 …

A precise, efficient, automated method to perform Limulus Amebocyte Lysate (LAL) tests has
been developed by using a new Toxinometer ET-201, which measures the turbidity change …

A new method is described for the quantitative detection of endotoxins in large volume
parenterals, based on the use of limulus amoebocyte lysate in combination with a …

The current status of the Limulus Amebocyte Lysate (LAL) test for final release of drug
products and devices in the United States and abroad is discussed. The principal problem …

A variety of large and small volume parenteral drugs were screened for amenability to
automated pyrogen testing with Limulus Amebocyte Lysate (LAL). The multiple …

The robot automated chromogenic substrate LAL assay method was evaluated for endotoxin
testing using three lots each of 12 pharmaceutical products. As many as 216 assays …

The observation that endotoxin caused gelation in extracts of Limulus amebocytes has been
expanded to the development of an in vitro kinetic, quantitative chromogenic LAL assay …