Äëÿ âíåäðåíèÿ ñóáñòàíöèè â ìåäèöèíñêóþ ïðàêòèêó â ðàìêàõ äîêëèíè÷åñêèõ èñïûòàíèé íåîáõîäèìî äîêàçàòåëüñòâî åå ÷èñòîòû. Îäíèì èç ïîêàçàòåëåé êîíòðîëÿ êà÷åñòâà ñóáñòàíöèè ÿâëÿåòñÿ ñîäåðaeàíèå îñòàòî÷íûõ îðãàíè÷åñêèõ ðàñòâîðèòåëåé, êîòîðûå ìîãóò âëèÿòü íà ôàðìàêîëîãè÷åñêóþ àêòèâíîñòü ëåêàðñòâåííîãî ïðåïàðàòà.  õîäå ñèíòåçà è âûäåëåíèÿ ñóáñòàíöèè èñïîëüçóþò ÷åòûðå ðàñòâîðèòåëÿ: äèõëîðìåòàí, ýòèëàöåòàò, ìåòèë-òðåò-áóòèëîâûé ýôèð (ÌÒÁÝ), í-ãåêñàí.  ðàáîòå ïðåäëîaeåíî äâà ñïîñîáà îïðåäåëåíèÿ îñòàòî÷íûõ îðãàíè÷åñêèõ ðàñòâîðèòåëåé ìåòîäîì ãàçîâîé õðîìàòîãðàôèè â ñóáñòàíöèè (2R,4R,4aR,7R,8aR)-4,7-äèìåòèë-2-(òèîôåí-2-èë)îêòàãèäðî-2H-õðîìåí-4-îë -ñ ââîäîì ãàçîâîé ïðîáû è ðàçäåëåíèåì îïðåäåëÿåìûõ êîìïîíåíòîâ íà êîì-ìåð÷åñêîé êàïèëëÿðíîé êîëîíêå HP-5ms (30 ì × 0,35 ìì × 0,25 ìêì); ñ ââîäîì aeèäêîé ïðîáû è ðàçäåëåíèåì íà êàïèëëÿðíîé êîëîíêå (30 ì × 0,32 ìì × 0,30 ìêì), çàïîëíåííîé ìîäèôèöèðîâàííûì ïîëè(1-òðèìåòèëñèëèë-1-ïðîïèíîì) (ÏÒÌÑÏ). Ïîñêîëüêó ïåðâûì ñïîñîáîì óäàëîñü îïðåäåëèòü òîëüêî í-ãåêñàí è ýòèëàöåòàò, áûëà ðàçðàáîòàíà è âàëèäèðîâàíà ìåòîäèêà îïðåäåëåíèÿ ÷åòûðåõ îñòàòî÷íûõ ðàñòâîðèòåëåé -äèõëîðìåòàíà, ýòèëàöåòàòà, ÌÒÁÝ, í-ãåêñàíà â èññëåäóåìîé ñóáñòàíöèè ìåòîäîì ãàçîâîé õðîìàòîãðàôèè íà êîëîíêå ñ ìîäèôèöèðîâàííîé ôàçîé íà îñíîâå ÏÒÌÑÏ. Îáíàðóaeåíû ñëåäîâûå êîëè÷åñòâà ýòèëàöåòàòà è ÌÒÁÝ, ñîäåðaeàíèÿ äèõëîðìåòàíà è í-ãåêñàíà â ñóáñòàíöèè -íèaeå ïðåäåëîâ îáíàðóaeåíèÿ. Ñðåäíèå ñîäåðaeàíèÿ ýòèëàöåòàòà è ÌÒÁÝ â ñóáñòàíöèè äëÿ 9 ïàðàëëåëüíûõ îïðåäåëåíèé ñîñòàâèëè 0,10 è 0,20 ppm, ÷òî íèaeå ÏÄÑ (5000 ppm) â 5 è 2,5 • 10 4 ðàç ñîîòâåòñòâåííî. Ïðîâåäåíà îöåíêà ðàçðàáîòàííîé ìåòîäèêè ïî ñëåäóþùèì õàðàêòåðèñòèêàì: ñïåöèôè÷íîñòü, ëèíåéíîñòü ãðàäóèðîâî÷íîãî ãðàôèêà, ïðàâèëüíîñòü, ïðåöèçèîííîñòü íà óðîâíå ïîâòîðÿåìîñòè è âíóòðèëàáîðàòîðíîé ïðåöèçèîííîñòè, óñòîé÷èâîñòü õðîìàòîãðàôè÷åñêîé ñèñòåìû. Ñòàíäàðòíûå îòêëîíåíèÿ ðåçóëüòàòîâ ïðè îïðåäåëåíèè ýòèëàöåòàòà è ÌÒÁÝ â ñóáñòàíöèè ñ èñïîëüçîâàíèåì ðàçðàáîòàííîé ìåòîäèêè íå ïðåâûøàþò 0,03 è 0,09 ñîîòâåòñòâåííî. Ìåòîäèêà ÿâëÿåòñÿ ñïåöèôè÷íîé, òî÷íîé è äîñòîâåðíîé äëÿ îïðåäåëåíèÿ îñòàòî÷íûõ îðãàíè÷åñêèõ ðàñòâîðèòåëåé â ñóáñòàíöèè.Êëþ÷åâûå ñëîâà: (2R,4R,4aR,7R,8aR)-4,7-äèìåòèë-2-(òèîôåí-2-èë)îêòàãèäðî-2H-õðîìåí-4-îë; ãàçîâàÿ õðîìàòîãðàôèÿ (ÃÕ); îñòàòî÷íûå îðãàíè÷åñêèå ðàñòâîðèòåëè; âàëèäàöèÿ.
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