Pyrogen Testing of Radiopharmaceuticals

No delay in testing Can be performed in radiopharmacy Container can be easily shielded No dilution of culture medium below normal strength Sample size variable Only one culture medium can be used Not officially recognized Not applicable if preservatives need to be diluted out 

For some products, a direct measurement of the level of bacterial endotoxins in the preparation is required. The test uses a lysate of amoebocytes from the horseshoe crab. 

MIBG metaidobenzoguanidine V maximum recommended dose in milliliters 

It is known that endotoxins are approximately 1000 times more toxic following intrathecal as opposed intravenous administration and this is recognized in the pharma-copeial monographs for products used intrathecally (e.g. Indium In -pentetate) since the maximum amount of endotoxin allowed is lower than for intravenous products. 

The use of commercially available products with marketing authorization that have been tested by the manufacturer will remove the need for routine determination of endotoxins. However, testing should be considered if it is thought that a particular product may be giving rise to problems. 

---