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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-7</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>РАЗРАБОТКА ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>DEVELOPMENT OF MEDICINES</subject></subj-group></article-categories><title-group><article-title>Новые возможности определения содержания действующих веществ в органических соединениях</article-title><trans-title-group xml:lang="en"><trans-title>New opportunities for the determination of active substances in organic compounds</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Митькина</surname><given-names>Л. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Mitkina</surname><given-names>L. I.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Научный центр экспертизы средств медицинского применения</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>13</day><month>02</month><year>2018</year></pub-date><volume>0</volume><issue>1</issue><fpage>19</fpage><lpage>21</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Митькина Л.И., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Митькина Л.И.</copyright-holder><copyright-holder xml:lang="en">Mitkina L.I.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.vedomostincesmp.ru/jour/article/view/7">https://www.vedomostincesmp.ru/jour/article/view/7</self-uri><abstract><p>В разработанной для Государственной фармакопеи Российской Федерации общей фармакопейной статье показана возможность применения прибора «элементный анализатор» для решения задач определения действующего вещества в лекарственных препаратах на основе определения элементов С, Н, N, S. Метод основан на высокотемпературном окислительном разложении в потоке гелия, либо в его смеси с кислородом в присутствии катализатора окисления до соответствующих этим элементам неорганических веществ, восстановлении окислов азота до молекулярного азота в присутствии катализатора восстановления и определении соответствующих продуктов разложения методом газовой хроматографии. Метод отличается быстротой определения и не требует использования стандартного образца действующего вещества.</p></abstract><trans-abstract xml:lang="en"><p>The general monograph developed for the Russian State Pharmacopoeia describes the opportunity for using special equipment called «elemental analyzer» to solve the problem of determining active ingredients in pharmaceuticals by determining the elements C, H, N, S. The method is based on the high-temperature oxidative decomposition in a stream of helium, or in its mixture with oxygen in the presence of an catalyst of oxidation to inorganic substances corresponding the mentioned elements, reduction of nitrogen oxides to molecular nitrogen in the presence of the respective reduction catalyst and determining the corresponding decomposition products by gas chromatography. This method is fast and does not require the analysis of a sample of an active substance.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>количественное определение</kwd><kwd>элементный анализ</kwd><kwd>содержание</kwd><kwd>assay</kwd><kwd>elemental analysis</kwd><kwd>content</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Государственная фармакопея СССР. 10-е изд. 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