Santos-Oliveira Ralph
Nuclear Engineering Institute, Radiopharmaceutical Division, Rua Hélio de Almeida No. 75, Ilha do Fundao, Rio de Janeiro, 21.941-906, Brazil.
J AOAC Int. 2010 Sep-Oct;93(5):1458-61.
Radiopharmaceuticals play an important role in modern nuclear medicine, and 18F-FDG (2-[18F] fluoro-2-deoxy-D-glucose) is the most frequently used in imaging examinations today. The pyrogen test represents an important parameter for the quality of radiopharmaceuticals since most of them, 18F-FDG included, are injectable solutions. However, the standard test proposed by the U.S. Pharmacopeia using limulus amebocyte lysates takes too long (about 1 h). An alternative test is the Portable Test System, which takes no more than 15 min. In order to compare both tests, 10 batches of 18F-FDG produced in the Nuclear Engineering Institute, Rio de Janeiro, Brazil, were analyzed. The results showed that in 40% of the samples analyzed, different results were found. From the total analyzed, 20% showed totally diverging results, and 80% demonstrated partial similarity. These differences have a great impact in the choice of the test used for radiopharmaceutical injectable solutions and the importance of validation tests before the implementation in the daily routine.
放射性药物在现代核医学中发挥着重要作用，18F-FDG（2-[18F]氟-2-脱氧-D-葡萄糖）是当今成像检查中最常用的。热原检测是放射性药物质量的一个重要参数，因为它们中的大多数，包括18F-FDG，都是注射用溶液。然而，美国药典提出的使用鲎试剂的标准检测耗时过长（约1小时）。一种替代检测方法是便携式检测系统，耗时不超过15分钟。为了比较这两种检测方法，对巴西里约热内卢核工程研究所生产的10批18F-FDG进行了分析。结果显示，在分析的样本中，40%发现了不同的结果。在所有分析样本中，20%显示出完全不同的结果，80%表现出部分相似性。这些差异对用于放射性药物注射溶液的检测方法的选择以及在日常工作中实施前验证检测的重要性有很大影响。
