Experience in Validation of Methods for Determination of Radiochemical Impurities in Radiopharmaceuticals

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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Bibliographic Details
Main Authors:	A. O. Malysheva, G. E. Kodina, E. A. Lyamtseva, N. A. Taratonenkova, A. S. Lunev
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
Series:	Регуляторные исследования и экспертиза лекарственных средств
Subjects:	radiopharmaceutical validation pharmacopoeia radionuclide technetium-99m radiochemical impurities quality control equivalent dose
Online Access:	https://www.vedomostincesmp.ru/jour/article/view/313

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