The 9 references with contexts in paper V. Krylov I., S. Moiseev V., O. Knyazkina V., V. Yashkir A., V. Merkulov A., В. Крылов И., С. Моисеев В., О. Князькина В., В. Яшкир А., В. Меркулов А. (2018) “Колоночная хроматография в очистке образца генотоксичной примеси субстанции иматиниба мезилат // Column chromatography USED in purification of genotoxic impurity sample of imatinib mesylate substance” / spz:neicon:vedomostincesmp:y:2016:i:3:p:42-45

1
Mashkovsky MD. Medicines. 16th ed. Moscow; 2012 (in Russian).
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    Âåäîìîñòè Íàó÷íîãî öåíòðà ýêñïåðòèçû ñðåäñòâ ìåäèöèíñêîãî ïðèìåíåíèÿ 2016; (3): 42–45. ÂÂÅÄÅÍÈÅ Èìàòèíèáà ìåçèëàò (I) — ïðîòèâîîïóõîëåâûé ïðåïàðàò,ýôôåêòèâíîïðèìåíÿåìûéâíàïðàâëåííîé ïðîòèâîðàêîâîé òåðàïèè ïðè õðîíè÷åñêîì ìèåëîëåéêîçå
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    . Åãî ñèíòåç îñíîâàí íà âçàèìîäåéñòâèè N-(5-àìèíî-2-ìåòèëôåíèë)-4-(3-ïèðèäèë)-2-ïèðèìèäèíàìèíà (II) è 4-[(4-ìåòèëïèïåðàçèí-1-èë)ìåòèë]áåíçîéíîé êèñëîòû èëè åå ïðîèçâîäíûõ ñ äàëüíåéøåé îáðàáîòêîé îáðàçóþùåãîñÿ àìèäà ìåòàíñóëüôîêèñëîòîé è ïîñëåäóþùåé ïåðåêðèñòàëëèçàöèåé ïîëó÷åííîé ñîëè (ðèñ. 1) [2–4].

2
Patent WO-2008/112722 A2 (2008). Available from: http:// goo.gl/NV9vVa.
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    Åãî ñèíòåç îñíîâàí íà âçàèìîäåéñòâèè N-(5-àìèíî-2-ìåòèëôåíèë)-4-(3-ïèðèäèë)-2-ïèðèìèäèíàìèíà (II) è 4-[(4-ìåòèëïèïåðàçèí-1-èë)ìåòèë]áåíçîéíîé êèñëîòû èëè åå ïðîèçâîäíûõ ñ äàëüíåéøåé îáðàáîòêîé îáðàçóþùåãîñÿ àìèäà ìåòàíñóëüôîêèñëîòîé è ïîñëåäóþùåé ïåðåêðèñòàëëèçàöèåé ïîëó÷åííîé ñîëè (ðèñ. 1)
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    . Íåñìîòðÿ íà ïðîâåäåííóþ î÷èñòêó, ôàðìàöåâòè÷åñêàÿ ñóáñòàíöèÿ (I) ìîæåò ñîäåðæàòü íåêîòîðîå êîëè÷åñòâî èñõîäíûõ âåùåñòâ (ïîñòîðîííèõ ïðèìåñåé), êîíòðîëü ïðèñóòñòâèÿ êîòîðûõ îñóùåñòâëÿåòñÿ ïðè îöåíêå ïîêàçàòåëåé êà÷åñòâà ñóáñòàíöèè.

4
Patent WO-2004/099187 A1 (2004); Available from: http:// goo.gl/IJIv4m.
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    Óñëîâèÿ õðîìàòîãðàôèðîâàíèÿ: êîëîíêà Poroshell 120 EC C-18 50 ìì ́4,6 ìì ́2,7 ìêì; òåìïåðàòóðàêîëîíêè26°Ñ;ïîäâèæíàÿôàçà—àöåòîíèòðèë-âîäà â ñîîòíîøåíèè 1:1 ñ äîáàâëåíèåì 0,1 % ìóðàâüèíîé êèñëîòû; ñêîðîñòü ïîòîêà — 0,400 ìë/ìèí; îáúåì ïðîáû — 0,5 ìêë; ðàñòâîðèòåëü — àöåòîíèòðèë. Ñèíòåçèðîâàííûé ïî ìåòîäèêå
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    (II) â êîëè÷åñòâå 300 ìã ðàñòâîðÿëè â 1 ìë àöåòîíèòðèëà è õðîìàòîãðàôèðîâàëè íà êîëîíêå äèàìåòðîì 35 ìì ÷åðåç ñëîé âûñîòîé 100 ìì íåéòðàëüíîãî îêèñè àëþìèíèÿ ïðîèçâîäñòâà «Chemapol» ìàðêè L40/250.

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    ßÌÐ1Í (ÄÌÑÎ-d6),d, ì.ä.: 2,06 (ñ, 3Í, CH3), 4,84 (óø. ñ, 2Í, NH2), 6,33 (ää, J 8,0 Ãö, J 2,0 Ãö), 6,79 (ä, J 2,0 Ãö, 1Í), 6,86 (ä, J 8,0 Ãö, 1Í), 7,36 (ä, J 5,3 Ãö, 1Í), 7,54 (ää, J 8,0 Ãö, J 4,8 Ãö, 1Í), 8,41 (ì, 1Í), 8,46 (ä, J 5,3 Ãö, 1Í), 8,66 (ñ, 1Í, NH), 8,69 (ä, J 4,8 Ãö, 1Í), 9,24 (ñ, 1Í). ÐÅÇÓËÜÒÀÒÛ È ÎÁÑÓÆÄÅÍÈÅ Àíàëèç ðåçóëüòàòîâ ÂÝÆÕ è ßÌÐ ñîåäèíåíèÿ (II), ïîëó÷åííîãî ïî ìåòîäèêå
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    , ïîêàçàë ïðèñóòñòâèå çíà÷èòåëüíîãî êîëè÷åñòâà ïðèìåñåé: ñîäåðæàíèå îñíîâíîãî êîìïîíåíòà íå ïðåâûøàåò 92 % (ðèñ.2, à;3, à).Ìåòîäî÷èñòêèñîåäèíåíèÿ(II)âðàìêàõ ìåòîäèêè [4] ïðåäóñìàòðèâàåò ïðîìûâêó ïîëó÷åííîãîöåëåâîãîïðîäóêòàèçîïðîïàíîëîìèìåòàíîëîì.

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    ÐÅÇÓËÜÒÀÒÛ È ÎÁÑÓÆÄÅÍÈÅ Àíàëèç ðåçóëüòàòîâ ÂÝÆÕ è ßÌÐ ñîåäèíåíèÿ (II), ïîëó÷åííîãî ïî ìåòîäèêå [4], ïîêàçàë ïðèñóòñòâèå çíà÷èòåëüíîãî êîëè÷åñòâà ïðèìåñåé: ñîäåðæàíèå îñíîâíîãî êîìïîíåíòà íå ïðåâûøàåò 92 % (ðèñ.2, à;3, à).Ìåòîäî÷èñòêèñîåäèíåíèÿ(II)âðàìêàõ ìåòîäèêè
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    ïðåäóñìàòðèâàåò ïðîìûâêó ïîëó÷åííîãîöåëåâîãîïðîäóêòàèçîïðîïàíîëîìèìåòàíîëîì.Ñëåäóåòîòìåòèòü,÷òîñîåäèíåíèå(II)èåãîïðèìåñè îáëàäàþò áëèçêîé ðàñòâîðèìîñòüþ â äàííûõ ðàñòâîðèòåëÿõ, ÷òî îñëîæíÿåò ïîëó÷åíèå (II) âûñîêîéñòåïåíè÷èñòîòû.

5
Bhatt V, Prasad G, Bhatt H, Sharma A. Quantification of potential genotoxic impurity in imatinib mesylate by LC-MS/MS. Acta Chim Pharm Indica 2013;3(2): 182–91.
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    Îñîáîå âíèìàíèå ïðè ôàðìàêîïåéíîì àíàëèçå êà÷åñòâà ñóáñòàíöèè (I) óäåëÿåòñÿ êîíòðîëþ îñòàòî÷íûõêîëè÷åñòâàìèíà(II),êîòîðûé,êàêèáîëüøèíñòâî àðîìàòè÷åñêèõ àìèíîâ, ÿâëÿåòñÿ ãåíîòîêñè÷íûì ñîåäèíåíèåì, ñïîñîáíûì âûçûâàòü îíêîëîãè÷åñêèå çàáîëåâàíèÿ
    Exact
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    .Âñîîòâåòñòâèèñðåêîìåíäàöèÿìè Åâðîïåéñêîãî ìåäèöèíñêîãî àãåíòñòâà (ÅÌÀ), ñîäåðæàíèå ñîåäèíåíèÿ II â ôàðìàöåâòè÷åñêîé ñóáñòàíöèè (I) íå äîëæíî ïðåâûøàòü 3 ppm [7].  íàøåé ñòðàíå òðåáîâàíèÿ ê åãî ñîäåðæàíèþ âàðüèðóþò îò 0,001 äî 1,0 % [8] â çàâèñèìîñòè îò ôèðìû-ïðîèçâîäèòåëÿ.

6
Madireddy V, Babu SK, Narayanareddy P. Stability-indicative, validated, fast HPLC method for quantification of two genotoxic impurities in imatinib mesylate. Global J of Analit Chem. 2011;2(5): 198–207.
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    Îñîáîå âíèìàíèå ïðè ôàðìàêîïåéíîì àíàëèçå êà÷åñòâà ñóáñòàíöèè (I) óäåëÿåòñÿ êîíòðîëþ îñòàòî÷íûõêîëè÷åñòâàìèíà(II),êîòîðûé,êàêèáîëüøèíñòâî àðîìàòè÷åñêèõ àìèíîâ, ÿâëÿåòñÿ ãåíîòîêñè÷íûì ñîåäèíåíèåì, ñïîñîáíûì âûçûâàòü îíêîëîãè÷åñêèå çàáîëåâàíèÿ
    Exact
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    .Âñîîòâåòñòâèèñðåêîìåíäàöèÿìè Åâðîïåéñêîãî ìåäèöèíñêîãî àãåíòñòâà (ÅÌÀ), ñîäåðæàíèå ñîåäèíåíèÿ II â ôàðìàöåâòè÷åñêîé ñóáñòàíöèè (I) íå äîëæíî ïðåâûøàòü 3 ppm [7].  íàøåé ñòðàíå òðåáîâàíèÿ ê åãî ñîäåðæàíèþ âàðüèðóþò îò 0,001 äî 1,0 % [8] â çàâèñèìîñòè îò ôèðìû-ïðîèçâîäèòåëÿ.

7
Guideline on the limits of genotoxic impurities, CPMP/SWP/ 5199/02, EMEA/CHMP/QWP/251344/2006. London; 2006. Available from: http:// goo.gl/CaQzef.
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    âíèìàíèå ïðè ôàðìàêîïåéíîì àíàëèçå êà÷åñòâà ñóáñòàíöèè (I) óäåëÿåòñÿ êîíòðîëþ îñòàòî÷íûõêîëè÷åñòâàìèíà(II),êîòîðûé,êàêèáîëüøèíñòâî àðîìàòè÷åñêèõ àìèíîâ, ÿâëÿåòñÿ ãåíîòîêñè÷íûì ñîåäèíåíèåì, ñïîñîáíûì âûçûâàòü îíêîëîãè÷åñêèå çàáîëåâàíèÿ[5, 6].Âñîîòâåòñòâèèñðåêîìåíäàöèÿìè Åâðîïåéñêîãî ìåäèöèíñêîãî àãåíòñòâà (ÅÌÀ), ñîäåðæàíèå ñîåäèíåíèÿ II â ôàðìàöåâòè÷åñêîé ñóáñòàíöèè (I) íå äîëæíî ïðåâûøàòü 3 ppm
    Exact
    [7]
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    .  íàøåé ñòðàíå òðåáîâàíèÿ ê åãî ñîäåðæàíèþ âàðüèðóþò îò 0,001 äî 1,0 % [8] â çàâèñèìîñòè îò ôèðìû-ïðîèçâîäèòåëÿ. Äëÿ êîíòðîëÿ ñîäåðæàíèÿ îñòàòî÷íûõ êîëè÷åñòâ II èñïîëüçóþò ìåòîä âûñîêîýôôåêòèâíîé æèäêîñòíîé õðîìàòîãðàôèè (ÂÝÆÕ), êîòîðûé íåâîçìîæåí áåç íàëè÷èÿ ñîîòâåòñòâóþùåãî ñòàíäàðòà.

8
Lutseva AI, Bokovikova TN, Stronova LA, Agapkina MV, Bunyatyan ND. The relevance of development of a unified approach to standardization of imatinib. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2014; (3): 9–12 (in Russian).
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    îñòàòî÷íûõêîëè÷åñòâàìèíà(II),êîòîðûé,êàêèáîëüøèíñòâî àðîìàòè÷åñêèõ àìèíîâ, ÿâëÿåòñÿ ãåíîòîêñè÷íûì ñîåäèíåíèåì, ñïîñîáíûì âûçûâàòü îíêîëîãè÷åñêèå çàáîëåâàíèÿ[5, 6].Âñîîòâåòñòâèèñðåêîìåíäàöèÿìè Åâðîïåéñêîãî ìåäèöèíñêîãî àãåíòñòâà (ÅÌÀ), ñîäåðæàíèå ñîåäèíåíèÿ II â ôàðìàöåâòè÷åñêîé ñóáñòàíöèè (I) íå äîëæíî ïðåâûøàòü 3 ppm [7].  íàøåé ñòðàíå òðåáîâàíèÿ ê åãî ñîäåðæàíèþ âàðüèðóþò îò 0,001 äî 1,0 %
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    â çàâèñèìîñòè îò ôèðìû-ïðîèçâîäèòåëÿ. Äëÿ êîíòðîëÿ ñîäåðæàíèÿ îñòàòî÷íûõ êîëè÷åñòâ II èñïîëüçóþò ìåòîä âûñîêîýôôåêòèâíîé æèäêîñòíîé õðîìàòîãðàôèè (ÂÝÆÕ), êîòîðûé íåâîçìîæåí áåç íàëè÷èÿ ñîîòâåòñòâóþùåãî ñòàíäàðòà.

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Crouch R, Russell D. Easy, Precise and Accurate Quantitative NMR Application note. Agilent Technologies Inc., USA; 2011. Available from: http:// goo.gl/6is1lW.
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    Àíàëèçèðóåìûå îáðàçöû â êîëè÷åñòâå 10 ìã ðàñòâîðÿëèâ0,5 ìëäåéòåðèðîâàííîãîäèìåòèëñóëüôîêñèäà (Cambridge Isotope Laboratories, Inc.), øêàëó õèìè÷åñêèõ ñäâèãîâ ãðàäóèðîâàëè ïî îòíîøåíèþ ê ñèãíàëó äåéòåðèðîâàííîãî ðàñòâîðèòåëÿ. Ñîäåðæàíèå (II) â îáðàçöå îïðåäåëÿëè ìåòîäîì êîëè÷åñòâåííîé ñïåêòðîñêîïèè ßÌÐ ñ èñïîëüçîâàíèåì âíåøíåãî ñòàíäàðòà ïî ìåòîäèêå
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    . Ýêñïåðèìåíò ïðîâîäèëè ïðè ñëåäóþùèõóñëîâèÿõ[10]:óãîëïîâîðîòàíàìàãíè÷åííîñòè90 °,âðåìÿðåëàêñàöèè30 ñ,1íàêîïëåíèå,÷èñëî òî÷åê àíàëîãî-öèôðîâîãî ïðåîáðàçîâàíèÿ 64 ê, ýêñïîíåíöèàëüíîå óìíîæåíèå 0,3 Ãö, àâòîìàòè÷åñêàÿ êîððåêöèÿ áàçîâîé ëèíèè ñïåêòðà, ðó÷íàÿ íàñòðîéêà ôàçû â äèàïàçîíå ñïåêòðà 0–10 ì.ä., äèàïàçîí èíòåãðèðîâàíèÿ çàäàâàëè âðó÷íóþ.

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    â êà÷åñòâåñîðáåíòàíåïðèâîäèòêäåñòðóêöèèèïîçâîëÿåò ïîëó÷èòü ñîåäèíåíèå (II) âûñîêîé ñòåïåíè ÷èñòîòû: íà õðîìàòîãðàììå (ðèñ. 2, á) ïðèñóòñòâóåò òîëüêî åãî ïèê (âðåìÿ âûõîäà 0,918 ìèí), â ñïåêòðå1H ßÌÐ (ðèñ. 3, á) íàáëþäàþòñÿ ñèãíàëû òîëüêî îñíîâíîãî ñîåäèíåíèÿ, â ìàññ-ñïåêòðå ïðèñóòñòâóåò èîí ñ m/z 278,1 Äà (ðèñ. 4). Ìåòîäîìêîëè÷åñòâåííîéñïåêòðîñêîïèè1HßÌÐ ñ èñïîëüçîâàíèåì âíåøíåãî ñòàíäàðòà
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    óñòàíîâëåíî, ÷òî ñîäåðæàíèå îñíîâíîãî êîìïîíåíòà â î÷èùåííîì ñîåäèíåíèè (II) ñîñòàâëÿåò 99,69 ± 0,16 %. ÇÀÊËÞ×ÅÍÈÅ Òàêèì îáðàçîì, èñïîëüçîâàíèå êîëîíî÷íîé õðîìàòîãðàôèè íà íåéòðàëüíîì îêñèäå àëþìèíèÿ ïîçâîëÿåò ïîëó÷èòü (II) ñ êîëè÷åñòâåííûì ñîäåðæàíèåì îñíîâíîãî êîìïîíåíòà ñâûøå 99 %, ÷òî äàåò âîçìîæíîñòü åãî èñïîëüçîâàíèÿ â ôàðìàêîïåéíîì àíàëèçå â êà÷åñòâå îòå÷åñòâåííîãî ñòàíäàðòíîãî îáðàçöà äëÿ

10
Kuzmina NE, Moiseev SV, Krylov VI, Yashkir VA, Merkulov VA. Possibilities of NMR spectrometry in determining trace components of mixtures. Zhurnal analiticheskoy himii 2014;69(11): 1052–60 (in Russian). AUTHORS
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    Àíàëèçèðóåìûå îáðàçöû â êîëè÷åñòâå 10 ìã ðàñòâîðÿëèâ0,5 ìëäåéòåðèðîâàííîãîäèìåòèëñóëüôîêñèäà (Cambridge Isotope Laboratories, Inc.), øêàëó õèìè÷åñêèõ ñäâèãîâ ãðàäóèðîâàëè ïî îòíîøåíèþ ê ñèãíàëó äåéòåðèðîâàííîãî ðàñòâîðèòåëÿ. Ñîäåðæàíèå (II) â îáðàçöå îïðåäåëÿëè ìåòîäîì êîëè÷åñòâåííîé ñïåêòðîñêîïèè ßÌÐ ñ èñïîëüçîâàíèåì âíåøíåãî ñòàíäàðòà ïî ìåòîäèêå [9]. Ýêñïåðèìåíò ïðîâîäèëè ïðè ñëåäóþùèõóñëîâèÿõ
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    :óãîëïîâîðîòàíàìàãíè÷åííîñòè90 °,âðåìÿðåëàêñàöèè30 ñ,1íàêîïëåíèå,÷èñëî òî÷åê àíàëîãî-öèôðîâîãî ïðåîáðàçîâàíèÿ 64 ê, ýêñïîíåíöèàëüíîå óìíîæåíèå 0,3 Ãö, àâòîìàòè÷åñêàÿ êîððåêöèÿ áàçîâîé ëèíèè ñïåêòðà, ðó÷íàÿ íàñòðîéêà ôàçû â äèàïàçîíå ñïåêòðà 0–10 ì.ä., äèàïàçîí èíòåãðèðîâàíèÿ çàäàâàëè âðó÷íóþ.