The core parts of the LAL test for endotoxin is described in the main pharmacopeia, but there are many things left out and others that are less clear, especially when training new staff.
This comprehensive guide describes how to:
- How to undertake method development.
- How to validate new samples.
- Explains concepts like maximum Valid Dilution and Endotoxin Limits.
- Outlines how to run a depyrogenation study.
- Looks at medical device testing.
- Contains a detailed trouble shooting guide.
This book provides a useful reference document for LAL users.