In-process 20-minute endotoxin "limit test" for positron emission tomography radiopharmaceuticals.
In-process 20-minute endotoxin "limit test" for positron emission tomography radiopharmaceuticals.
复制标题
正电子发射断层扫描放射性药物的过程中 20 分钟内毒素“极限测试”。
DOI：
10.1331/154434506775268670
复制
发表时间：
2006
影响因子：
2.1
通讯作者：
J. Hung
中科院分区：
文献类型：
--
作者：
J. Hung
目标
讨论与美国药典总则823>；“用于正电子发射断层扫描的放射性药物--合成”中的20分钟内毒素“限度检查”(20分钟细菌内毒素检查[BET])有关的各种问题。
数据源
2005年USP的网络版，以及已出版的生物医学文献中的其他相关文章。
摘要
本文讨论了用于阳性对照的最低内毒素水平、最小允许给药量、上述试验的程序和解释，以及是否需要20分钟的BET以及是否适合使用物理半衰期小于20分钟的放射性核素标记的正电子发射断层扫描(PET)放射性药物。目前的USP和其他与20分钟BET成绩有关的出版物都没有就所讨论的问题提供完整的详细信息或解释。
结论
为了让最终用户准确，更重要的是，忠实地执行上述测试，需要随时提供关于20分钟BET的具体信息。
OBJECTIVES
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".
DATA SOURCES
The online version of 2005 USP, and other relevant articles from the published biomedical literature.
SUMMARY
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.
CONCLUSION
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.