Sorting out of Interference in detection of Endotoxins in Parenteral Drugs

Ramesh Pennamareddy and Prabakar
Jamal Mohamed College (Autonomous), Tiruchirappalli, Tamil Nadu, India.

Abstract:

Bacterial Endotoxins test is one of the important test for parenteral drugs and medical devices which are coming in contact with the blood stream. When Endotoxins come in contact with the blood stream induces white blood cells to release cytokines which mediate a complex biological response including pyrogensity, shock, coagulation and inflammation, sometimes leads to death. So it is mandatory to test Endotoxins in parenteral drugs and medical devices.The Endotoxins are checked by Limulus Amoebocyte Lysate test but in most of the drugs due to some inhibitory factors the test is showing false negative/ positive results, upon injection of such drugs may leads to severe complications in patients. The factors responsible for these interference are investigated in some of the Cephalosporin dugs, medical devices and biologics.

Keywords: Interference, Limulus Amoebocyte Lysate (LAL), Control Standard Endotoxin (CSE).