In-process 20-minute endotoxin "limit test" for positron emission tomography radiopharmaceuticals

To discuss various issues related to the in-process 20-minute endotoxin "limit test" (20-minute bacterial endotoxin test [BET]) per the United Stated Pharmacopeia (USP) general chapter <823>, "Radiopharmaceuticals for Positron Emission Tomography--Compounding".

The online version of 2005 USP, and other relevant articles from the published biomedical literature.

The minimum endotoxin level to be used for the positive controls, minimum allowable volume for administration, procedure and interpretation of the above test, and whether the 20-minute BET is required and suitable for use with any positron emission tomography (PET) radiopharmaceutical labeled with a radionuclide having a physical half-life less than 20 minutes are discussed in this article. Neither the current USP nor other publications related to the performance of the 20-minute BET provide complete detailed information or explanation with regard to the issues discussed.

To allow end users to accurately and, more importantly, faithfully execute the above testing, specific information needs to be made readily available concerning the 20-minute BET.