Experience in Validation of Methods for Determination of Radiochemical Impurities in Radiopharmaceuticals
Most important quality attributes of any radiopharmaceutical (RPh) are its radiochemical purity (RCP) or content of radiochemical impurities (RCIs) that have to comply with respective norms and limits. However, at present, there is no unified approach to validation of analytical methods in the conte...
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Main Authors: | A. O. Malysheva, G. E. Kodina, E. A. Lyamtseva, N. A. Taratonenkova, A. S. Lunev |
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Format: | Article |
Language: | Russian |
Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2020-12-01
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Series: | Регуляторные исследования и экспертиза лекарственных средств |
Subjects: | |
Online Access: | https://www.vedomostincesmp.ru/jour/article/view/313 |
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