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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OOO “Vashe Tsifrovoe Izdatelstvo”
2018-02-01
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Series: | Ведомости Научного центра экспертизы средств медицинского применения |
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Online Access: | https://www.vedomostincesmp.ru/jour/article/view/29 |
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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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1721268627206832128 |