Pharmacopoeial Requirements for Elemental Impurities in Radiopharmaceuticals (Review)

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Pharmacopoeial Requirements for Elemental Impurities in Radiopharmaceuticals (Review)

INTRODUCTION. Current risk-based general strategies for the control of elemental impurities in medicinal products, as documented in the elemental impurity monographs of national and world pharmacopoeias, do not apply to radiopharmaceuticals. Manufacturers of radiopharmaceuticals have to determine an...

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Bibliographic Details
Main Authors:	V. M. Shchukin, N. E. Kuz'mina, R. D. Ruziev, D. A. Pripadchev, M. A. Kuznetsov
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’) 2023-08-01
Series:	Регуляторные исследования и экспертиза лекарственных средств
Subjects:	pharmacopoeial requirements radiopharmaceuticals pet precursors chemical precursors elemental impurities metal impurities elemental impurity level
Online Access:	https://www.vedomostincesmp.ru/jour/article/view/751
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