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

snafu2000 said:

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

Dear,
thanks for the information!