Relevant issues of testing quality of drugs in the form of tablets
The article reviews major ways of streamlining approaches to testing the following quality parameters of drugs presented in the dosage form oftablets: “Identification”, “Dissolution”, “Disintegration”, “Related impurities”, “Residual organic solvents”, “Assay”. The article describes results of a com...
Main Authors: | , , , |
---|---|
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/54 |
id |
doaj-609bc6a675f64656bae85f76144b6864 |
---|---|
record_format |
Article |
spelling |
doaj-609bc6a675f64656bae85f76144b68642021-07-28T14:04:07ZrusOOO “Vashe Tsifrovoe Izdatelstvo”Ведомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-0103535952Relevant issues of testing quality of drugs in the form of tabletsE. L. Kovaleva0O. A. Matveeva1E. E. Kolganova2M. M. Mironova3Federal 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 FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationThe article reviews major ways of streamlining approaches to testing the following quality parameters of drugs presented in the dosage form oftablets: “Identification”, “Dissolution”, “Disintegration”, “Related impurities”, “Residual organic solvents”, “Assay”. The article describes results of a comparative analysis of requirements laid down in the leading world pharmacopoeias, WHO documents and national requirements for tablets standardization. The analysis covers such issues as classification of drugs, terms used to describe various tablet groups, differences in the choice of test methods, as well as in approaches to assessment of parameters and use of reference standards. The analysis makes it possible to define national requirements for tablets quality, which is particularly important in view of the future work on the development of pharmacopoeial monographs on drugs for the State Pharmacopoeia of the Russian Federation.https://www.vedomostincesmp.ru/jour/article/view/54лекарственные препаратытаблеткикачествопримесирастворениераспадаемостьорганические растворителиdrugstabletsqualityimpuritiesdissolutiondisintegrationorganic solvents |
collection |
DOAJ |
language |
Russian |
format |
Article |
sources |
DOAJ |
author |
E. L. Kovaleva O. A. Matveeva E. E. Kolganova M. M. Mironova |
spellingShingle |
E. L. Kovaleva O. A. Matveeva E. E. Kolganova M. M. Mironova Relevant issues of testing quality of drugs in the form of tablets Ведомости Научного центра экспертизы средств медицинского применения лекарственные препараты таблетки качество примеси растворение распадаемость органические растворители drugs tablets quality impurities dissolution disintegration organic solvents |
author_facet |
E. L. Kovaleva O. A. Matveeva E. E. Kolganova M. M. Mironova |
author_sort |
E. L. Kovaleva |
title |
Relevant issues of testing quality of drugs in the form of tablets |
title_short |
Relevant issues of testing quality of drugs in the form of tablets |
title_full |
Relevant issues of testing quality of drugs in the form of tablets |
title_fullStr |
Relevant issues of testing quality of drugs in the form of tablets |
title_full_unstemmed |
Relevant issues of testing quality of drugs in the form of tablets |
title_sort |
relevant issues of testing quality of drugs in the form of tablets |
publisher |
OOO “Vashe Tsifrovoe Izdatelstvo” |
series |
Ведомости Научного центра экспертизы средств медицинского применения |
issn |
1991-2919 2619-1172 |
publishDate |
2018-02-01 |
description |
The article reviews major ways of streamlining approaches to testing the following quality parameters of drugs presented in the dosage form oftablets: “Identification”, “Dissolution”, “Disintegration”, “Related impurities”, “Residual organic solvents”, “Assay”. The article describes results of a comparative analysis of requirements laid down in the leading world pharmacopoeias, WHO documents and national requirements for tablets standardization. The analysis covers such issues as classification of drugs, terms used to describe various tablet groups, differences in the choice of test methods, as well as in approaches to assessment of parameters and use of reference standards. The analysis makes it possible to define national requirements for tablets quality, which is particularly important in view of the future work on the development of pharmacopoeial monographs on drugs for the State Pharmacopoeia of the Russian Federation. |
topic |
лекарственные препараты таблетки качество примеси растворение распадаемость органические растворители drugs tablets quality impurities dissolution disintegration organic solvents |
url |
https://www.vedomostincesmp.ru/jour/article/view/54 |
work_keys_str_mv |
AT elkovaleva relevantissuesoftestingqualityofdrugsintheformoftablets AT oamatveeva relevantissuesoftestingqualityofdrugsintheformoftablets AT eekolganova relevantissuesoftestingqualityofdrugsintheformoftablets AT mmmironova relevantissuesoftestingqualityofdrugsintheformoftablets |
_version_ |
1721268591927492608 |