【摘要】：為了更好地控制雷美替胺的質(zhì)量,設(shè)計并合成了雷美替胺的3種降解雜質(zhì)。分別為(S)-N-[2-(4-羥基-2,6,7,8-四氫-1H-茚并[5,4-b]呋喃-8-基)乙基]丙酰胺(IP1)、2-羥基-N-[2-[(S)-2,6,7,8-四氫-1H-茚并[5,4-b]呋喃-8-基]乙基]丙酰胺(IP2)和N-[2-(2,6-二氫-1H-茚并[5,4-b]呋喃-8-基)乙基]丙酰胺(IP3),所得產(chǎn)物經(jīng)~1HNMR、~(13)CNMR和HRMS確證結(jié)構(gòu)。破壞性試驗證明,酸性條件主要產(chǎn)生雜質(zhì)IP1與IP3,氧化條件下主要產(chǎn)生雜質(zhì)IP2。
[Abstract]:In order to better control the quality of remetidine, three kinds of degradation impurities were designed and synthesized. The products are (S) N- [2- (4-hydroxy-2oxy) -7- (tetrahydro-8-) -1H-indeno [54-b] furan-8- ethyl] propionamide (IP1), 2-hydroxy-N- [2- [(S) -2o _ 6N _ (7H) -tetrahydro-1H-) and [54-b] furan -8indenyl] ethyl] propionamide (IP2), respectively, and N- [2- (2- (2o 6- dihydro-1H-) and [54-b] furan-8-) ethyl] propionamide (IP3), respectively. The obtained products are as follows: N- [2- (2-) -dihydro-1H- and [54-b] furan-8-) ethyl] propionamide (IP3). The structure was confirmed by ~ 1HN MR13 CNMR and HRMS. The destructive test shows that the main impurity IP1 is produced under acidic condition and the impurity IP2. is produced under the condition of IP3, oxidation.
【作者單位】： 揚子江藥業(yè)集團有限公司;
【分類號】：R943

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