Dear colleagues,
could anyone tell me which are the limits of endotoxin present in antigenic preparations to stimulate cell cultures allowed in Europe and/or in USA?
Thanks in advance,
Elisabeth

Guideline on Validation of LAL test as an end-product endotoxin test for human and animal parenetnal drugs, biological products, and medical devices........Appendix E

US Dept. of Heath and Human Services
Public Health Service
FDA

Has everything you need to know (if not, it will tell you where to get) reguarding Endotoxin testing and limits