rmjournalЭталоны. Стандартные образцыMeasurement Standards. Reference Materials2687-0886D. I. Mendeleyev Institute for Metrology10.20915/2687-0886-2021-17-2-33-47rmjournal-299Research ArticleСтандартные образцыReference materialsСтандартные образцы растительных материалов – инструмент обеспечения единства химических измерений в геохимии, экологии, сельском хозяйстве и фармакологииPlant-matrix reference materials as a tool for ensuring the uniformity of chemical measurements in geochemistry, ecology, agriculture and pharmacologyhttps://orcid.org/0000-0001-6315-083XВасильеваИ. Е.Vasil’evaI. E.

Васильева Ирина Евгеньевна – д-р техн. наук, главный научный сотрудник группы атомно-эмиссионных методов анализа и стандартных образцов ФГБУН Институт геохимии им. А. П. Виноградова Сибирского отделения Российской академии наук (ИГХ СО РАН)

664033, г. Иркутск, ул. Фаворского, д. 1А

Researcher ID: E-7873–2013

Irina E. Vasil’eva – D. Sc. (Eng.), Chief researcher, group of atomic emission analysis methods and reference materials in P.Vinogradov Institute of Geochemistry, Siberian Branch of Russian Academy of Sciences (IGC SB RAS)

1А Favorsky str., Irkutsk, 664033

Researcher ID: E-7873–2013

vasira@igc.irk.ruhttps://orcid.org/0000-0002-6444-612XШабановаЕ. В.ShabanovaE. V.

Шабанова Елена Владимировна – д-р физ.-мат. наук, старший научный сотрудник, руководитель группы атомно-эмиссионных методов анализа и стандартных образцов ГБУН Институт геохимии им. А. П. Виноградова Сибирского отделения Российской академии наук (ИГХ СО РАН)

664033, г. Иркутск, ул. Фаворского, д. 1А

Researcher ID: E-4333–2013

Elena V. Shabanova – D. Sc. (Phys. and Mat.), Senior researcher, Head of the group of atomic emission analysis methods and reference materials in A. P. Vinogradov Institute of  Geochemistry, Siberian Branch of Russian Academy of Sciences (IGC SB RAS)

1А Favorsky str., Irkutsk, 664033

Researcher ID: E-4333–2013

shev@igc.irk.ruФГБУН Институт геохимии им. А. П. Виноградова Сибирского отделения Российской академии наукРоссияA. P. Vinogradov Institute of Geochemistry, Siberian Branch of Russian Academy of Sciences (IGC SB RAS)Russian Federation2021100820211723347Copyright © Васильева И.Е., Шабанова Е.В., 20212021Васильева И.Е., Шабанова Е.В.Vasil’eva I.E., Shabanova E.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rmjournal.ru/jour/article/view/299

В целях сохранения окружающей среды и её безопасности для населения нужна достоверная информация о химическом составе растений и разнообразной продукции из них. В связи с увеличением объемов трансграничной торговли растёт спрос на прослеживаемые результаты определения содержаний химических элементов в растениях, а не только белков, жиров, углеводов, пестицидов, влаги, витаминов и т. п., которые могут повлиять на качество жизни человека. Получение надежных измерений элементного состава сельскохозяйственных и дикорастущих растений, разнообразной продукции на их основе является актуальной, но сложной аналитической задачей. Стандартные образцы (СО) – общепризнанный инструмент обеспечения единства химических измерений – предназначены для аттестации (валидации) существующих и новых методов (методик) химического анализа, сертификационных исследований при разработке стандартных образцов и квалификационного тестирования лабораторий. В статье перечислены авторитетные производители референтных растительных материалов, в которых аттестованы содержания химических элементов. Оценено соотношение сертифицированных, референтных образцов растительной матицы и образцов для контроля качества. Приведена классификация сертифицированных стандартных образцов на основании типа растительного материала, применяемого по их пищевому назначению. Показан вклад разных стран в разработку растительных СО. Возможность выбора растений для разработки новых СО обсуждается с двух точек зрения, а именно: системы пищевых составов (AOAC INTERNATIONAL) и парадигмы создания отпечатка пальца «Референтных растений» (B. Markert). На основании обобщения исследований, посвященных разработке и применению матричных стандартных образцов растительных материалов, составлен список наиболее важных требований к референтным материалам, обеспечивающим надежность и сопоставимость результатов химического анализа в сферах биологии, геохимии, экологии, сельского хозяйства, медицины, а также в междисциплинарных исследованиях.

The population needs reliable information on the chemical composition of plants and products made from them in order to preserve the environment and its safety. With the increase in cross-border trade, there is a growing demand for traceable results of determining the content of chemical elements in plants and not only proteins, fats, carbohydrates, pesticides, moisture, vitamins, etc., which can affect the quality of human life. An urgent but difficult analytical task is to obtain reliable measurements of the elemental composition of agricultural and wild plants and various products made from them. Reference materials (RMs) are a widely recognized tool for ensuring the uniformity of chemical measurements. They are designed for certification (validation) of existing and new methods (techniques) of chemical analysis, certification studies in the development of reference materials, and professional testing of laboratories. The article lists the reputable manufacturers of plant RMs in which the content of chemical elements is certified. The ratio of certified, reference, and quality control samples of plant-matrix has been assessed. The classification of certified reference materials according to the type of plant material used for their food application is provided. The contribution of different countries to the development of plant CRMs is hown. The selection of plants for the development of new RMs is discussed from two points of view, namely food composition databases (AOAC INTERNATIONAL) and the ‘Reference Plant’ chemical fingerprinting (B. Markert). Based on the consolidation of studies devoted to the development and appliance of plant-matrix reference materials, a list of the most important requirements has been compiled for reference materials that ensure the reliability and comparability of the results of chemical analysis in the fields of biology, geochemistry, ecology, agriculture, medicine, and interdisciplinary research.

обеспечение единства измеренийстандартные образцы растительных материаловэлементный состав растенийсписок требований к матричным растительным СОensuring the uniformity of measurementsplant-matrix certified reference materialselemental plant compositionrequirements for plant-matrix CRMsИсследование проведено в рамках выполнения государственного задания по Проектам IX.127.1.4. «Эколого-геохимические преобразования экосистем Восточной Сибири под воздействием природных и техногенных факторов» № 0350-2019-0005 и № 0284-2021-0005 «Развитие методов исследования химического состава и структурного состояния природных и техногенных сред в науках о Земле».References2010.1. IUCN red list of threatened species: summary statistics // International union for conservation of nature and natural resources. URL: https://www.iucnredlist.org2010.1. IUCN red list of threatened species: summary statistics. In: International union for conservation of nature and natural resources. Available at https://www.iucnredlist.org.Katz S. A. Bowen’s Kale: A brief review dedicated to the late Professor Humphry John Moule Bowen, 1929–2001. Journal of radioanalytical and nuclear chemistry. 2002. Vol. 251. № 1. Pp. 3–5. https://doi.org/10.1023/A:1015021823497Katz S. A. Bowen’s Kale: A brief review dedicated to the late Professor Humphry John Moule Bowen, 1929–2001. Journal of radioanalytical and nuclear chemistry. 2002;251(1):3–5. https://doi.org/10.1023/A:1015021823497.Об обеспечении единства измерений: Федер. закон Рос. Федерации от 26 июня 2008 г. № 102-ФЗ: принят Гос. Думой Федер. Собрания Рос. Федерации 11 июня 2008 г.: одобрен Советом Федерации Федер. Собр. Рос. Федерации 18 июня 2008 г. (в редакции от 27 декабря 2019 г. № 496-ФЗ) // Рос. газета. 2019. 31 декабря.Federal low «On ensuring the uniformity of measurements» No. FZ-102 of 26.06.2008. (In Russ.). Available at http://fundmetrology.ru/depository/01_npa/102-fz_2015.pdf.ГОСТ ISO/IEC17025–2019 Общие требования к компетентности испытательных и калибровочных лабораторий (Переиздание). Издание официальное. М.: Стандартинформ, 2020. 25 с.GOST ISO/IEC17025–2019 General requirements for the competence of testing and calibration laboratories. Moscow: Standartinform Publ.; 2020. 13 p. (In Russ.).Linsinger T. P. J., Emons H. The role of reference materials in chemical metrology. CHIMIA International journal for chemistry. 2009. Vol. 63. № 10. Pp. 629–631. https://doi.org/10.2533/chimia.2009.629Linsinger T. P. J., Emons H. The role of reference materials in chemical metrology. CHIMIA International journal for chemistry. 2009;63(10):629–631. https://doi.org/10.2533/chimia.2009.629Васильева И. Е., Шабанова Е. В. Стандартные образцы геологических материалов и объектов окружающей среды: проблемы и решения // Журнал аналитической химии. 2017. Т. 72. № 2. С. 129–146. https://doi.org/10.7868/S0044450217020141Vasil’eva, I. E., Shabanova, E. V. Certified reference materials of geological and environmental objects: Problems and solutions. Journal of analytical chemistry. 2017;72(2):99–118. https://doi.org/10.1134/S1061934817020149Trends in developments of certified reference materials for chemical analysis – focus on food, water, soil, and sediment matrices / I. R. B. Olivares [et al.] // TrAC Trends in analytical chemistry. 2018. № 100. Pp. 53–64. https://doi.org/10.1016/j.trac.2017.12.013Olivares I. R. B., Souza G. B., Nogueira A. R. A., Toledo G. T. K., Marcki D. C. Trends in developments of certified reference materials for chemical analysis – Focus on food, water, soil, and sediment matrices. TrAC Trends in analytical chemistry. 2018;100:53–64. https://doi.org/10.1016/j.trac.2017.12.013Hulme N., Hammond J. Is your spectrophotometer still «pharma compliant»? A review of the new European pharmacopoeia 10th edition // SPECTROSCOPY EUROPE. 2020. Vol. 32. № 1. Pp. 14–20. URL: https://www.spectroscopyeurope.com/article/your-spectrophotometer-still-»pharma-compliant»-review-new-european-pharmacopoeia-10thHulme N., Hammond J. Is your spectrophotometer still «pharma compliant»? A review of the new European pharmacopoeia 10th edition. SPECTROSCOPYEUROPE. 2020;32(1):14–20. Available from: https://www.spectroscopyeurope.com/article/your-spectrophotometer-still-»pharma-compliant»-review-new-european-pharmacopoeia-10thВасильева И. Е., Шабанова Е. В. Стандартные образцы растительных материалов – инструмент обеспечения единства химических измерений // Журнал аналитической химии. 2021. T. 76. № 2. С. 99–123. https://doi.org/10.31857/S0044450221020146 10.31857/S0044450221020146Vasil’eva, I. E., Shabanova, E. V. Plant-matrix certified reference materials as a tool for ensuring the uniformity of chemical measurements. Journal of analytical chemistry. 2021;76(2):137–155. https://doi.org/10.1134/S1061934821020143Каталог стандартных образцов состава природных и техногенных сред // ИГХ СО РАН [сайт]. URL: http://www.igc.irk.ru/images/Innovation/Standarts-obr/CATALOGUE_OF_CRMs_IGC_SB_RAS_-2017.pdfСatalogue of certified reference materials of natural and man-made media compositions from A. P. Vinogradov Institute of Geochemisty SB RAS. Available at: http://www.igc.irk.ru/images/Innovation/Standarts-obr/CATALOGUE_OF_CRMs_IGC_SB_RAS_-2017.pdfWolf W. R., Andrews K. W. A system for defining reference materials applicable to all food matrices // Fresenius journal of analytical chemistry. 1995. Vol. 352. № 1–2. Pp. 73–76. https://doi.org/10.1007/BF00322300Wolf W. R., Andrews K. W. A system for defining reference materials applicable to all food matrices Fresenius. Journal of analytical chemistry. 1995;352(1–2):73–6. https://doi.org/10.1007/BF00322300Wise S. A., Phillips M. M. Evolution of reference materials for the determination of organic nutrients in food and dietary supplements – a critical review. Analytical and bioanalytical chemistry. 2019. Vol. 411. № 1. Pp. 97–127. https://doi.org/10.1007/s00216-018-1473-0Wise S. A., Phillips M. M. Evolution of reference materials for the determination of organic nutrients in food and dietary supplements – a critical review. Analytical and bioanalytical chemistry. 2019;411(1):97–127. https://doi.org/10.1007/s00216-018-1473-0Markert B. Establishing of «Reference Plant» for inorganic characterization of different plant species by chemical fingerprinting // Water, air, soil pollut. 1992. Vol. 64. № 3–4. Pp. 533–538. https://doi.org/10.1007/BF00483363Markert B. Establishing of «Reference Plant» for inorganic characterization of different plant species by chemical fingerprinting. Water, Air, Soil Pollut. 1992;64(3–4):533–538. https://doi.org/10.1007/BF00483363Owen J. D., Kirton S. B., Evans S. J., Stair J. L. Elemental fingerprinting of Hypericum perforatum (St John’s Wort) herb and preparations using ICP-OES and chemometrics // Journal of pharmaceutical and biomedical analysis. 2016. Vol. 125. № 5. Pp. 15–21. https://doi.org/10.1016/j.jpba.2016.02.054.Owen J. D., Kirton S. B., Evans S. J., Stair J. L. Elemental fingerprinting of Hypericum perforatum (St John’s Wort) herb and preparations using ICP-OES and chemometrics. Journal of pharmaceutical and biomedical analysis. 2016;125(5):15–21. https://doi.org/10.1016/j.jpba.2016.02.054A chemometrics as a powerful tool in the elucidation of the role of metals in the biosynthesis of volatile organic compounds in Hungarian thyme samples / J. Arsenijević [et al.] // Plant physiology and biochemistry. 2013. Vol. 71. № 10. Pp. 298–306. https://doi.org/10.1016/j.plaphy.2013.08.002Arsenijević J., Marković J., Šoštarić I., Ražić S. A chemometrics as a powerful tool in the elucidation of the role of metals in the biosynthesis of volatile organic compounds in Hungarian thyme samples. Plant physiology and biochemistry. 2013;71(10):298–306. https://doi.org/10.1016/j.plaphy.2013.08.002.Elemental profiling and geographical differentiation of Ethiopian coffee samples through inductively coupled plasma-optical emission spectroscopy (ICP-OES), ICP mass spectrometry (ICP-MS) and direct mercury analyzer (DMA) / G. Habte [et al.] // Food chemistry. 2016. Vol. 212(Dec 1). Pp. 512–520. https://doi.org/10.1016/j.foodchem.2016.05.178Habte G., Hwang I. M., Kim J. S., Hong J. H., Hong Y. S., Choi J. Y. et al. Elemental profiling and geographical differentiation of Ethiopian coffee samples through inductively coupled plasma-optical emission spectroscopy (ICP-OES), ICP mass spectrometry (ICPMS) and direct mercury analyzer (DMA). Food chemistry. 2016;212(Dec 1):512–520. https://doi.org/10.1016/j.foodchem.2016.05.178Jurkin D., Zgorelec Z., Rinkovec J. Concentrations of Pt, Pd and Rh in soil and vegetation: A review. // Journal of central European agriculture. 2019. Vol. 20. № 2. Pp. 686–699. https://doi.org//10.5513/JCEA01/20.2.2199Jurkin D., Zgorelec Z., Rinkovec J. Concentrations of Pt, Pd and Rh in soil and vegetation: A review. Journal of central European agriculture. 2019;20(2):686–699. https://doi.org//10.5513/JCEA01/20.2.2199Nagajyoti P. C., Lee K. D., Sreekanth T. V. M. Heavy metals, occurrence and toxicity for plants: A review // Environmental chemistry letters. 2010. Vol. 8. № 3. Pp. 199–216. https://doi.org/10.1007/s10311-010-0297-8Nagajyoti P. C., Lee K. D., Sreekanth T. V. M. Heavy metals, occurrence and toxicity for plants: a review. Environmental chemistry letters. 2010;8(3):199–216. https://doi.org/10.1007/s10311-010-0297-8Comparison of the element composition in several plant species and their substrate from a 1500000-km2 area in Northern Europe / C. Reimann [et al.] // Science of the Total Environment. 2001. Vol. 278. № 1–3. Pp. 87–112. https://doi.org/10.1016/S0048–9697(00)00890-1Reimann C., Koller F., Frengstad B., Kashulina G., Niskavaara H., Englmaier P. Comparison of the element composition in several plant species and their substrate from a 1500000-km2 area in Northern Europe. Science of the Total Environment. 2001;278(1–3): 87–112. https://doi.org/10.1016/S0048–9697(00)00890-1Application of X-ray fluorescence analytical techniques in phytoremediation and plant biology studies / M. Nečemer [et al.] // Spectrochimica acta part B: atomic spectroscopy. 2008. Vol. 63. № 11. Pp. 1240–1247. https://doi.org/10.1016/j.sab.2008.07.006Nečemer M., Kump P., Ščančar J., Jaćimović R., Simčič J., Pelicon P., Budnar M., Jeran Z., Pongrac P., Regvar M., Vogel-Mikuš K. Application of X-ray fluorescence analytical techniques in phytoremediation and plant biology studies. Spectrochimica acta part B: atomic spectroscopy. 2008;63(11):1240–1247. https://doi.org/10.1016/j.sab.2008.07.006Kroukamp E. M., Wondimu T., Forbes P. B. C. Metals and metalloids speciation in plants: overview, instrumentation, approaches and commonly assessed elements // Trends in analytical chemistry. 2016. Vol. 77. Pp. 87–99. https://doi.org/10.1016/j.trac.2015.10.007Kroukamp E. M., Wondimu T., Forbes P. B. C. Metals and metalloids speciation in plants: Overview, instrumentation, approaches and commonly assessed elements. Trends in analytical chemistry. 2016;77:87–99. https://doi.org/10.1016/j.trac.2015.10.007.Eggen O. A., Reimann C., Flem B. Reliability of geochemical analyses: deja vu all over again // Science of the total environment. 2019. Vol. 670. Pp.138–148. https://doi.org/10.1016/j.scitotenv.2019.03.185Eggen O. A., Reimann C., Flem B. Reliability of geochemical analyses: deja vu all over again. Science of the total environment. 2019;670:138–148. https://doi.org/10.1016/j.scitotenv.2019.03.185The uptake and bioaccumulation of heavy metals by food plants, their effects on plants nutrients, and associated health risk: a review / A. Khan [et al.] // Environmental science and pollution research. 2015. Vol. 22. № 18. Pp. 13772–13799. https://doi.org/10.1007/s11356-015-4881-0Khan A., Khan S., Khan M. A., Qamar Z., Waqas M. The uptake and bioaccumulation of heavy metals by food plants, their effects on plants nutrients, and associated health risk: a review. Environmental science and pollution research. 2015;22(18):13772–13799. https://doi.org/10.1007/s11356-015-4881-0Understanding element composition of medicinal plants used in herbalism – a case study by analytical atomic spectrometry / P. Pohl [et al.] // Journal of pharmaceutical and biomedical analysis. 2018. Vol. 159. Pp. 262–271. https://doi.org/10.1016/j.jpba.2018.06.017Pohl P., Bielawska-Pohl A., Dzimitrowicz A., Greda K., Jamroz P., Lesniewicz A. et al. Understanding element composition of medicinal plants used in herbalism – A case study by analytical atomic spectrometry. Journal of pharmaceutical and biomedical analysis. 2018;159:262–271. https://doi.org/10.1016/j.jpba.2018.06.017Pr inciples of plant nutrition. 5th ed. / Eds. K. Mengel [et al.]. Dordrecht: Springer Netherlands; 2001. 849 p. https://doi.org/10.1007/978-94-010-1009-2Mengel K., Kirkby E. A., Kosegarten H., Appel T. Principles of Plant Nutrition. 5th ed. Dordrecht: Springer Netherlands; 2001. 849 p. https://doi.org/10.1007/978-94-010-1009-2.Pl ant analysis procedures. 2nd ed. / Eds. E. E. J. M. Temminghoff [et al.]. Dordrecht: Springer Netherlands; 2004. 179 p. https://doi.org/10.1007/978-1-4020-2976-9Temminghoff E. E. J. M., Houba V. J. G. Plant Analysis Procedures. 2nd Ed. Dordrecht: Springer Netherlands; 2004. 179 p. https://doi.org/10.1007/978-1-4020-2976-9Gr eenberg R. R., Bode P., Fernandes E. A. N. Neutron activation analysis: a primary method of measurement // Spectrochimica acta part B: atomic spectroscopy. 2011. Vol. 66. № 3–4. Pp. 193–241. https://doi.org/10.1016/j.sab.2010.12.011Greenberg R. R., Bode P., Fernandes E. A. N. Neutron activation analysis: A primary method of measurement. Spectrochimica acta part B: atomic spectroscopy. 2011;66(3–4):193–241. https://doi.org/10.1016/j.sab.2010.12.011Vanhoo f C., Bacon J. R., Ellis A. T., Fittschen U. E. A., Vincze L. 2019 atomic spectrometry update – A review of advances in X-ray fluorescence spectrometry and its special applications // Journal of analytical atomic spectrometry. 2019. Vol. 34. № 9. Pp. 1750– 1767. https://doi.org/10.1039/C9JA90042JVanhoof C., Bacon J. R., Ellis A. T., Fittschen U. E. A., Vincze L. 2019 atomic spectrometry update – a review of advances in X-ray fluorescence spectrometry and its special applications. Journal of analytical atomic spectrometry. 2019;34(9):1750–1767. https://doi.org/10.1039/C9JA90042JRecent adva nces and future trends in LIBS applications to agricultural materials and their food derivatives: An overview of developments in the last decade (2010–2019). Part II. Crop plants and their food derivatives / G. S. Senesi // Trends in Analytical Chemistry. 2019. Vol. 118. Pp. 453–469. https://doi.org/10.1016/j.trac.2019.05.052Senesi G. S., Cabral J., Menegatti C. R., Marangoni B., Nicolodelli G. Recent advances and future trends in LIBS applications to agricultural materials and their food derivatives: An overview of developments in the last decade (2010–2019). Part II. Crop plants and their food derivatives. Trends in Analytical Chemistry. 2019;118;453–469. https://doi.org/10.1016/j.trac.2019.05.052Цизин Г. И., Статкус М. А., Золотов Ю. А. Сорбционное и экстракционное концентрирование микрокомпонентов в проточных системах анализа // Журнал аналитической химии. 2015. Т. 70. № 11. С. 1123. https://doi.org/10.7868/S0044450215110171Tsizin G. I., Statkus M. A., Zolotov Yu. A. Adsorption and extraction preconcentration of trace components in flow analytical systems. Journal of analytical chemistry. 2015;70(11):1289–1306. https://doi.org/10.1134/S1061934815110167ISO Guide 33:2015 Reference materials. Good practice in using reference materials. Geneva: BSI. 2015. URL: https://www.iso.org/standard/46212.htmlISO Guide 33:2015. Reference materials. Good practice in using reference materials. Geneva; BSI: 2015. Available at https://www.iso.org/standard/46212.htmlISO/IEC Guide 98–3:2008 Uncertainty of measurement – Part 3: Guide to the expression of uncertainty in measurement (GUM:1995). Geneva: BSI. 2008. URL: https://www.iso.org/standard/50461.html.ISO/IEC Guide 98–3:2008. Uncertainty of measurement – Part 3: Guide to the expression of uncertainty in measurement (GUM:1995). Geneva; ISO: 2008. Available at: https://www.iso.org/standard/50461.htmlГОСТ ISO Guide 35–2015 Стандартные образцы. Общие и статистические принципы сертификации (аттестации). М.: Стандартинформ. 2016. 6 с.ISO Guide 35–2015 Reference materials – General and statistical principles of certification. Moscow; Standartinform: 2016. (In Russ.).World Health Organizati on. National policy on traditional medicine and regulation of herbal medicines: Report of a WHO global survey. Geneva, 2005. URL: https://apps.who.int/iris/bitstream/handle/10665/43229/9241593237.pdf?sequence=1World Health Organization. National policy on traditional medicine and regulation of herbal medicines: Report of a WHO global survey. Geneva, 2005.Государственная фармакоп ея Российской Федерации. XIII издание: Материал опубликован 06 ноября 2015. Обновлён 24 ноября 2015 // Министерство здравоохранения РФ [сайт]. URL: https://www.rosminzdrav.ru/poleznye-resursy/gosudarstvennaya-farmakopeya-rossiyskoy-federatsii-xiii-izdaniyaState Pharmacopoeia of the Russian Federation, XIII edn. Moscow, 2016. Available at: https://www.rosminzdrav.ru/poleznye-resursy/gosudarstvennaya-farmakopeya-rossiyskoy-federatsii-xiii-izdaniya.Государственная фармакопея Российской Федерации. XIV издание. М: 2018 // Министерство здравоохранения РФ [сайт]. URL: http://www.femb.ru/femb/pharmacopea.phpState Pharmacopoeia of the Russian Federation, XIV edn. Moscow, 2018. Available at: http://www.femb.ru/femb/pharmacopea.php.О введении в действие санитарных правил: пост. Главного государственного санитарного врача РФ от 14 ноября 2001 г. № 36 (в ред. от 6 июля 2011 г.) // Портал ГАРАНТ.РУ [сайт]. URL: https://base.garant.ru/4178234/Resolution of the chief state sanitary doctor of the Russian Federation «On the introduction of sanitary rules» dated November 14, 2001 No 36 (as amended on July 6, 2011). SanPiN2.3.2.1078–01. Hygienic requirements for food safety and nutritional value. Available at: https://base.garant.ru/4178234/Elemental Impuritie s – Limits: First Supplement of USP 40-NF35, Official December 1, 2017 // United States Pharmacopeia. General Chapter. URL: https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/key-issues/232–40–35–1s.pdfUnited States Pharmacopeia. General Chapter <232> Elemental Impurities – Limits: First Supplement of USP 40-NF35, Official December 1, 2017. Available at: https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/keyissues/232–40–35–1s.pdf.Elemental Impu rities – Procedures. Chemical Tests: Second Supplement to USP 38–NF 33 // United States Pharmacopeia. General Chapter. URL: https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/key-issues/c233.pdfUnited States Pharmacopeia. General Chapter <233> Elemental Impurities – Procedures / Chemical Tests: Second Supplement to USP 38–NF 33. Available at: https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/key-issues/c233.pdf.ICH International Council for Harmonisation of Technical Requirement for Pharmaceuticals for Human Use, Harmonised Guideline , Guideline for Elemental Impurities Q3D (R1) (Final version Adopted on 22 March 2019). URL: https://www.ema.europa.eu/e/documents/scintific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-32.pdf^mICH International Council for Harmonisation of Technical Requirement for Pharmaceuticals for Human Use, Harmonised Guideline, Guideline for Elemental Impurities Q3D (R1) (Final version Adopted on 22 March 2019). Available at: https://www.ema.europa.eu/e/documents/scintific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-32.pdf^m

The authors declare that there are no conflicts of interest present.