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

作者信息

Zeevaart Jan Rijn, Olsen Sylva

机构信息

Radiochemistry, Necsa (South African Nuclear Energy Corporation Ltd.), P.O. Box 582, Pretoria, 0001, South Africa.

出版信息

Appl Radiat Isot. 2006 Jul;64(7):812-4. doi: 10.1016/j.apradiso.2006.01.002. Epub 2006 Feb 28.

DOI:10.1016/j.apradiso.2006.01.002
PMID:16503145
Abstract

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.

摘要

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