Pharmacy Inspection Podcast

Learning Objectives Discuss the importance of low levels of endotoxins in parenteral preparations Discuss the limits for endotoxins for various routes of administration Discuss ways to control the levels of endotoxins in final preparations In this weeks' 483 we're going to be talking about Bacterial Endotoxins and the testing related to endotoxins. Let's first take a look at the observation then we'll discuss what endotoxins are and why it's important to keep them out of your preparations. First thing that should be talked about specific to this 483 is that we're dealing with preparations that are intrathecals or will be injected into the spinal fluid. One thing to know about intrathecal injections in particular is that they have a lower limit for endotoxins than other injections. When performing final testing for preparations one of the tests is a bacterial endotoxin test. This test is performed according to USP Chapter Bacterial Endotoxins Test. For parenterals that are not intended for