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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-42</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>ГОСУДАРСТВЕННАЯ ФАРМАКОПЕЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>STATE PHARMACOPOEIA</subject></subj-group></article-categories><title-group><article-title>Общие фармакопейные статьи и фармакопейные статьи Государственной фармакопеи Российской Федерации XIII издания</article-title><trans-title-group xml:lang="en"><trans-title>General monographs and pharmacopoeial monographs of the State pharmacopoeia of Russian Federation XIII edition</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>Меркулов</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Merkulov</surname><given-names>V. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Саканян</surname><given-names>Е. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Sakanyan</surname><given-names>E. I.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шемерянкина</surname><given-names>Т. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Shemeryankina</surname><given-names>T. B.</given-names></name></name-alternatives><email xlink:type="simple">Shemeryankina@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мочикина</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Mochikina</surname><given-names>O. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Бунятян</surname><given-names>Н. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Bunyatyan</surname><given-names>N. D.</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>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2015</year></pub-date><pub-date pub-type="epub"><day>13</day><month>02</month><year>2018</year></pub-date><volume>0</volume><issue>2</issue><fpage>54</fpage><lpage>58</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Меркулов В.А., Саканян Е.И., Шемерянкина Т.Б., Мочикина О.А., Бунятян Н.Д., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Меркулов В.А., Саканян Е.И., Шемерянкина Т.Б., Мочикина О.А., Бунятян Н.Д.</copyright-holder><copyright-holder xml:lang="en">Merkulov V.A., Sakanyan E.I., Shemeryankina T.B., Mochikina O.A., Bunyatyan N.D.</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/42">https://www.vedomostincesmp.ru/jour/article/view/42</self-uri><abstract><p>Государственная фармакопея Российской Федерации представляет собой свод общих фармакопейных статей и фармакопейных статей и подлежит переизданию не реже І раза в 5 лет. Очередное издание Государственной фармакопеи Российской Федерации, планируемое к выходу в свет в 2015 году, будет включать как впервые разработанные в практике отечественного, а в ряде случаев и мирового фармакопейного анализа общие фармакопейные статьи и фармакопейные статьи, так и статьи, представляющие собой обновленные и пересмотренные варианты общих фармакопейных статей и фармакопейных статей. Введение в действие общих фармакопейных статей и фармакопейных статей этого издания Государственной фармакопеи Российской Федерации позволит существенно повысить уровень отечественного фармакопейного анализа и обеспечит его соответствие требованиям мировых стандартов.</p></abstract><trans-abstract xml:lang="en"><p>The State Pharmacopoeia of the Russian Federation is a collection of general monographs and pharmacopoeial monographs. It should be reissued at least once in 5 years. The next scheduled edition of the State Pharmacopoeia of the Russian Federation is planned for publication in 2015. It will include both first developed in national and, in some cases, global pharmacopoeial analysis general and pharmacopoeial monographs, and updated revised general and pharmacopoeial monographs. The implementation of the general and pharmacopoeial monographs of the mentioned edition of the State Pharmacopoeia of the Russian Federation will significantly increase the level of national pharmacopoeial analysis and ensure its compliance with international standards.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>State Pharmacopoeia</kwd><kwd>general monograph</kwd><kwd>pharmacopoeial monograph</kwd><kwd>drug quality</kwd><kwd>pharmacopoeial analysis</kwd><kwd>государственная фармакопея</kwd><kwd>общая фармакопейная статья</kwd><kwd>фармакопейная статья</kwd><kwd>качество лекарственных средств</kwd><kwd>фармакопейный анализ</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. М.: Медицина; 1968.</mixed-citation><mixed-citation xml:lang="en">The State Pharmacopoeia of USSR. 10th ed. 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