The 16 references in paper E. Kovaleva L., O. Matveeva A., E. Kolganova E., M. Mironova M., Елена Ковалева Леонардовна, Оксана Матвеева Анатольевна, Екатерина Колганова Евгеньевна, Мария Миронова Михайловна (2018) “Актуальные вопросы оценки качества препаратов в лекарственной форме «таблетки» // Relevant issues of testing quality of drugs in the form of tablets” / spz:neicon:vedomostincesmp:y:2015:i:3:p:53-59

1
Draft Order of the Russian Ministry of Health «On approving the list of types of dosage forms». Available from: http://regulation.gov.ru/project/23007 (in Russian).
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2
European Pharmacopoeia 8th ed., Supplement 8.2. European Directorate for the Quality of Medicines. Available from: http:// online.edqm.eu/entry.htm.
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3
The State Pharmacopoeia of USSR. 11th ed. V. 2. Moscow: Meditsina; 1989 (in Russian).
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4
The State Pharmacopoeia of Russian Federation. 12th ed. V. 1. Moscow: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation; 2007 (in Russian).
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5
Good pharmacopoeial practices. Working document QAS/13.526/Rev.6 July 2015. Document for comments. Available from: http:// www.who.int/medicines/areas/quality_safety/quality_assurance/GPhP-QAS13-526-Rev6-meeting_24072015.pdf.
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6
OST 91500.05.001-00 «Standards for Quality of Medicines. Basic provisions» (approved by the order of the Ministry of Health dated November 1, 2001 No 388, repealed from 29 May 2015 on the basis of Order Ministry of Health of Russia on April 24th, 2015 No 209n) (in Russian).
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7
Mironov AN, ed. Guideline for expertise of drugs. V. II. Moscow: Grif i K; 2013 (in Russian).
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8
General Pharmacopeial article «Dissolution» OFS 42-0003-04 (approved by the Federal Service on Surveillance in Healthcare and Social Development Order from 13.09.2004 No 145-PR/04) (in Russian).
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9
Order of the Russian Ministry of Health on April 24, 2015 No 209n Invalidity of the order of the Ministry of Health of the Russian Federation dated November 1, 2001 No 388 «About the state quality standards of drugs» (in Russian).
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10
List of general pharmacopoeial articles and pharmacopoeial articles. Available from: http://www.rosminzdrav.ru/ministry/61/11/materialy-po-deyatelnosti-deparatamenta/stranitsa-856/spisok-obschih-farmakopeynyh-statey (in Russian).
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11
British Pharmacopoeia 2015th ed. The British Pharmacopoeia Commission. Available from: https:// www.pharmacopoeia.com.
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12
United States Pharmacopeia, 38th edition Available from: http://www.uspnf. com/uspnf.
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13
Specifications: Test Procedures and Acceptance Criteria for New Drug Sub-stances and New Drug Products: Chemical Substances Q6A ICH harmonized tripartite guideline. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf.
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14
OST 42-506-96 «Procedure for the development, coordination and approval of regulatory documents on medicines and medicinal herbs» (in Russian).
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15
Impurities in New Drug Products Q3B(R2) ICH harmonized tripartite guideline. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__Guideline.pdf.
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16
Impurities in Drug Substances and Drug Products (<1086>). Available from: http://www.usp.org/sites/default/files/usp_pdf/EN/chapter_1086.pdf. R E F E R E N C E S Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства
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