The 11 references in paper N. Kuz’Mina E., S. Moiseev V., V. Krylov I., A. Kutin A., E. Zhukov A., V. Yashkir A., V. Merkulov A., Н. Кузьмина Е., С. Моисеев В., В. Крылов И., А. Кутин А., Е. Жуков А., В. Яшкир А., В. Меркулов А. (2018) “Валидация методики определения аминокислотного состава фармацевтической субстанции «Глатирамера ацетат» методом13C ЯМР-спектроскопии // Validation of the procedure for determination of amino acids composition of glatiramer acetate by C-13 NMR spectroscopy” / spz:neicon:vedomostincesmp:y:2017:i:3:p:175-181

1
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Kuz’mina NE, Moiseev SV, Krylov VI, Kutin AA, Yashkir VA, Merkulov VA. Development of the procedure for determination of amino acids composition of glatiramer acetate by NMR spectroscopy. Pharmaceutical Chemistry Journal 2017; 51(3); 45–8 (in Russian).
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3
Kuz’mina NE, Moiseev SV, Yashkir VA, Osintseva EV. The possibility of the nuclear magnetic resonance methods using for reference standards certification. Reference materials 2014; (2): 19–25 (in Russian).
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Malz F, Jancke H.Validation of quantitative nuclear magnetic resonance. J Pharm Biomed Anal. 2005; 38(5): 813–23.
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Yurgel NV, ed. Guideline for Analytical Methods Validation for Drugs. Methodological Recommendations. Moscow: Sport i Kul’tura-2000; 2007 (in Russian).
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Beregovykh VV, ed. Validation of analytical methods by drug manufacturers. Guiding principles for drug manufacturers. Moscow: Litterra; 2008 (in Russian).
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General monograph 1.1.0012.15. Validation of analytical procedures. State Pharmacopoeia of the Russian Federation. 13th ed. V. I. Moscow; 2015. Available from: http://femb.ru/feml (in Russian).
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Nuclear Magnetic Resonance. United States Pharmacopoeia. National Formulary USP 40 — NF 35. Rockville; 2016.
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RMG 61–2003 GSI. Accuracy, trueness and precision of quantitative chemical analysis. Methods of evaluation. Moscow: Izdatelstvo standartov; 2004 (in Russian).
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State Standard R ISO 5725-2–2002. Accuracy (trueness and precision) of measurement methods and results. Part 2. Basic method for determination of repeatability and reproducibility of a standard method of measurement. Moscow: Izdatelstvo standartov; 2002 (in Russian).
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11
Dolittski B-Z. Method of preparation of polypeptide mixtures using purified hydrobromic acid. Patent RF, ¹ 2388764 C2; 2010 (in Russian). AUTHORS Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health
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