On the issue of assessing the quality of preservatives used in current practice of immunobiological preparations production

The analysis of national and foreign normative documents regulating modern requirements for preservative quality assessment has been performed. The need for elaboration of modern requirements for quality assessment and standardization of preservatives used in the production of immunobiological prepa...

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Main Authors: V. P. Bondarev, T. M. Kargina, E. I. Sakanyan
Format: Article
Language:Russian
Published: OOO “Vashe Tsifrovoe Izdatelstvo” 2018-02-01
Series:Ведомости Научного центра экспертизы средств медицинского применения
Subjects:
Online Access:https://www.vedomostincesmp.ru/jour/article/view/29
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spelling doaj-ad251af06e814c85b65503aa91a0aba12021-07-28T14:04:07ZrusOOO “Vashe Tsifrovoe Izdatelstvo”Ведомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-0101535827On the issue of assessing the quality of preservatives used in current practice of immunobiological preparations productionV. P. Bondarev0T. M. Kargina1E. I. Sakanyan2Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationThe analysis of national and foreign normative documents regulating modern requirements for preservative quality assessment has been performed. The need for elaboration of modern requirements for quality assessment and standardization of preservatives used in the production of immunobiological preparation in accordance with the good manufacturing and laboratory practice (GMP and GLP) has been justified. The conducted analysis has shown that the most common preservatives in immunobiological preparations are thiomersal, phenol and formaldehyde. The requirements for these preservatives have been elaborated and systematized. International and national assay methods and requirements for thiomersal, phenol, formaldehyde, have been characterized. The results of the studies have been used in elaboration of general chapters related to the assay of thiomersal, phenol and formaldehyde in immunobiological preparations. The projects of general chapters have been approved the minutes of the Board of the Ministry of Health of the Russian Federation on the State Pharmacopoeia and proposed for inclusion in the State Pharmacopoeia of the Russian Federation XIII edition. The constant increase in the range of immunobiological preparations shows the need for further research of preservatives as a part of their content, as well as for studying their properties, mechanism of action and combinations with other preservatives.https://www.vedomostincesmp.ru/jour/article/view/29консервантытиомерсалфенолформальдегидиммунобиологический лекарственный препаратpreservativesthiomersalphenolformaldehydeimmunobiological preparation
collection DOAJ
language Russian
format Article
sources DOAJ
author V. P. Bondarev
T. M. Kargina
E. I. Sakanyan
spellingShingle V. P. Bondarev
T. M. Kargina
E. I. Sakanyan
On the issue of assessing the quality of preservatives used in current practice of immunobiological preparations production
Ведомости Научного центра экспертизы средств медицинского применения
консерванты
тиомерсал
фенол
формальдегид
иммунобиологический лекарственный препарат
preservatives
thiomersal
phenol
formaldehyde
immunobiological preparation
author_facet V. P. Bondarev
T. M. Kargina
E. I. Sakanyan
author_sort V. P. Bondarev
title On the issue of assessing the quality of preservatives used in current practice of immunobiological preparations production
title_short On the issue of assessing the quality of preservatives used in current practice of immunobiological preparations production
title_full On the issue of assessing the quality of preservatives used in current practice of immunobiological preparations production
title_fullStr On the issue of assessing the quality of preservatives used in current practice of immunobiological preparations production
title_full_unstemmed On the issue of assessing the quality of preservatives used in current practice of immunobiological preparations production
title_sort on the issue of assessing the quality of preservatives used in current practice of immunobiological preparations production
publisher OOO “Vashe Tsifrovoe Izdatelstvo”
series Ведомости Научного центра экспертизы средств медицинского применения
issn 1991-2919
2619-1172
publishDate 2018-02-01
description The analysis of national and foreign normative documents regulating modern requirements for preservative quality assessment has been performed. The need for elaboration of modern requirements for quality assessment and standardization of preservatives used in the production of immunobiological preparation in accordance with the good manufacturing and laboratory practice (GMP and GLP) has been justified. The conducted analysis has shown that the most common preservatives in immunobiological preparations are thiomersal, phenol and formaldehyde. The requirements for these preservatives have been elaborated and systematized. International and national assay methods and requirements for thiomersal, phenol, formaldehyde, have been characterized. The results of the studies have been used in elaboration of general chapters related to the assay of thiomersal, phenol and formaldehyde in immunobiological preparations. The projects of general chapters have been approved the minutes of the Board of the Ministry of Health of the Russian Federation on the State Pharmacopoeia and proposed for inclusion in the State Pharmacopoeia of the Russian Federation XIII edition. The constant increase in the range of immunobiological preparations shows the need for further research of preservatives as a part of their content, as well as for studying their properties, mechanism of action and combinations with other preservatives.
topic консерванты
тиомерсал
фенол
формальдегид
иммунобиологический лекарственный препарат
preservatives
thiomersal
phenol
formaldehyde
immunobiological preparation
url https://www.vedomostincesmp.ru/jour/article/view/29
work_keys_str_mv AT vpbondarev ontheissueofassessingthequalityofpreservativesusedincurrentpracticeofimmunobiologicalpreparationsproduction
AT tmkargina ontheissueofassessingthequalityofpreservativesusedincurrentpracticeofimmunobiologicalpreparationsproduction
AT eisakanyan ontheissueofassessingthequalityofpreservativesusedincurrentpracticeofimmunobiologicalpreparationsproduction
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