Recent trends in the concept of specific activity: Impact on radiochemical and radiopharmaceutical producers

In the radiochemical and radiopharmaceutical industry, the concepts and subsequent specification used for determining the purity of the radiopharmaceutical product are of concern to both the regulator and the producer. It is therefore of profound importance that these concepts such as specific radioactivity are used correctly and their meaning fully understood. Recent changes in the pharmacopoeias are evaluated and the implications thereof discussed. On the basis thereof suggestions are made for definitions, specifications and tests.