The 18 references in paper N. Epshtein A., Н. Эпштейн А. (2018) “О допустимых значениях порога игнорирования примесей и отношения сигнал/шум при проверке чувствительности хроматографической системы // On acceptable values of disregard limits for impurities and signal-to-noise ratio when checking chromatographic system sensitivity” / spz:neicon:vedomostincesmp:y:2017:i:2:p:85-91

1
State Pharmacopoeia of the Russian Federation. 13th ed. V. I. Moscow; 2015. Available from: http://femb.ru/feml (in Russian).
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2
European Pharmacopoeia. 9th ed. Strasbourg; 2017.
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3
Frequently Asked Questions about the EDQM and Helpdesk List. Topics: 04. European Pharmacopoeia & International Harmonisation. 01. General Chapters and Monographs. 06. Impurities Chromatography. 05. How to determine the total impurities? Which peaks can be disregarded? Available from: https:// goo.gl/9AfcqH.
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4
Technical Guide for the Elaboration of Monographs. 7th ed. EDQM. European Pharmacopoeia; 2015. Available from: https:// goo.gl/EVp8kf.
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5
ICH Harmonised Tripartite Guideline. Q3A(R2). Impurities in New Drug Substances. ICH; 2006.
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6
ICH Harmonised Tripartite Guideline. Q3B(R2). Impurities in New Drug Products. ICH; 2006.
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7
Meyer C, Seiler P, Bies C, Cianciulli C, Watzig H, Meyer VR. Minimum required signal-to-noise ratio for optimal precision in HPLC and CE. Electrophoresis 2012; 33(11): 1509–16.
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8
Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC Method Development. 2nd ed. New York: J. Wiley; 1997.
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9
United States Pharmacopoeia. National Formulary USP 39 — NF 34. Rockville; 2016.
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10
Kuss H-J, Kromidas S, eds. Quantification in LC and GC. A practical guide to good chromatographic data. Wheinheim: WILEY-VCH Verlag GmbH& Co, KGaA; 2009.
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11
ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1). ICH; 2005.
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12
Epshtein NA. Validation of HPLC Techniques for Pharmaceutical Analysis. Pharmaceutical Chemistry Journal 2004; 38(4): 40–56 (in Russian).
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13
Beregovykh VV, ed. Validation of analytical procedures for drug manufacturers. Guiding principles for drug manufacturers. Moscow: Litterra; 2008 (in Russian).
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14
HPLC Simulator 6.0. Available from: http:// hplc-simulator.software.informer.com/6.0/.
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15
Meyer VR. Practical High-Performance Liquid Chromatography. 5th ed. Chichester: John Wiley and Sons; 2010.
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16
Pauls RE, McCoy RW, Ziegel ER, Wolf T, Fritz GT, Marmion DM. Results of a Cooperative Study Comparing the Precision of Peak Height and Area Measurements in Liquid Chromatography. Part II. J Chromatogr Sci 1986; 24(7): 273–7.
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17
Commentary USP 39 — NF 34. US Pharmacopeial Convention. November 2, 2015. Available from: https:// goo.gl/wPovtY.
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18
Chambers D, Kelly G, Limentani G, Lister A, Lung KR, Warner E. Analytical method equivalency: An acceptable analytical practice. Pharmaceut Technol. 2005; 29: 64–80. AUTHORS Autonomous corporation «STADA PharmDevelopment», JSC «NIZHPHARM», Avtomobilny passage 6, Moscow 109029, Russian Federation.
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