Scientific research enabled the formulation of methodological approaches to the standardization of biological, herbal, and homeopathic drugs and their analytical methods included in the Russian Federation State Pharmacopoeia XIIIth Ed. The developed General Pharmacopoeial Articles and Pharmacopoeial Articles are fundamental elements of the standardization of medicines circulated on the Russian Federation pharmaceutical market.
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Federal Law of the Russian Federation dated Apr. 12, 2010, No. 61-FZ “On Circulation of Medicines,” Moscow (2010).
A. G. Tsyndymeev, Yu. V. Olefir, V. A. Merkulov, and E. I. Sakanyan, Vedom. NTsESMP, No. 2, 4 – 7 (2016).
WHO International Meeting of World Pharmacopoeias “Review of World Pharmacopoeias”, WHO, Geneva, Executive Board Room, Feb. 29-Mar. 2, 2012, Working Document QAS/12.512/Rev.1.
State Pharmacopoeia of the RF [in Russian], XIII Ed., Vols. 1 – 3 (2015); http://femb.ru
T. M. Kargina, I. G. Osipova, E. I. Sakanyan, and A. A. Movsesyants, Bioprep. Profil. Diagn. Lech., 16(3), 131 – 138 (2016).
I. G. Osipova, V. F. Evlashkina, D. S. Davydov, and E. I. Sakanyan, Mezhdunar. Zh. Prikl. Fundam. Issled., No. 6 – 2, 272 – 276 (2016).
United States Pharmacopoeia, 39th Ed., United States Pharmacopeial Convention; http://www.uspnf.com/uspnf/login (accession date Nov. 25, 2016).
European Pharmacopoeia, 9th Ed., EDQM; http://online.edqm.eu/entry.htm (accession date Nov. 25, 2016).
British Pharmacopoeia, 13th Ed.; http://fc4fs1/comfo1$/Pharmacopeia/BP2013/bp2013
The Japanese Pharmacopeia, 16th Ed., Pharmaceuticals and Medical Devices Agency, Tokyo (2011).
Pharmacopoeia of the People’s Republic of China, Vols. 1 and 2, China Medical Science Press, Beijing (2010).
Expert committee on biological standardization/WHO/BS/2015.2253
State Pharmacopoeia of the USSR, Xth Ed., Collection of Common State Standards and Positions Normalizing Drug Quality, M. D. Mashkovskii, Meditsina, Moscow (1968).
State Pharmacopoeia of the USSR, No. 1, 11th Ed. Suppl., General methods of analysis, Meditsina, Moscow (1987).
State Pharmacopoeia of the USSR, No. 2, 11th Ed. Suppl., General methods of analysis. Medicinal Plant Raw Material, Meditsina, Moscow (1989).
State Pharmacopoeia of the Russian Federation, XIIth Ed., Part 1, NTsESMP, Moscow (2007).
M. M. Mironova and E. L. Kovaleva, Khim.-farm. Zh., 50(12), 49 – 54 (2016).
I. V. Shilova, T. G. Khoruzhaya, and I. G. Samylina, Khim.-farm. Zh., 49(5), 42 – 46 (2013); Pharm. Chem. J., 49(5), 329 – 333 (2015).
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 51, No. 2, pp. 40 – 45, February, 2017.
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Sakanyan, E.I., Shemeryankina, T.B., Osipova, I.G. et al. Establishment of Pharmacopoeial Quality Standards for the State Pharmacopoeia of the Russian Federation. Pharm Chem J 51, 136–141 (2017). https://doi.org/10.1007/s11094-017-1572-9
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DOI: https://doi.org/10.1007/s11094-017-1572-9