杂质检查分析方法建立过程中破坏性试验的意义和存在的问题分析.pdfVIP

Ch ine e Journal of New D rug 2008, Vol. 17 N o. 17 2008 17 17 ( 国家食品药品监督管理局药品审评中心, 北京 100038) [] 破坏性试验是杂质检测方法建立时验 专属性检测灵敏度的重要试验内容之 一, 能提供药 品可能的降解途径和降解产物的信息由于破坏性试验的实验过程复杂, 在技术审评过程中经常发现该项 实验的实验条件设计不合理实验参数确定依据不充分实验结果评价分析不全面等问题现对如何有效 全面测定破坏性试验中产生的降解产物, 合理开展破坏性试验研究做一分析 [] 破坏性试验; 杂质; 分析方法 [] R927. 12 [] C [] 1003- 3734( 2008) 17- 1548- 02 E ffects of stressing test for determ ination of im purities during validation of the ana lytical procedure CHENG H aiping ( Centerf or D rug E valuation, State Food and D rug A dm in istration, Be ij ing 100038, Ch ina) [ Ab stract] The tre ing te t i one of the key te t validated pecificity and en itiv ity of analytical proce dure of determ ination of mi puritie , and can prov ide inform ation about degradation proce and degradation product of drug ub tance and drug product . Due to com plex ity of the tre ing te t, there are a lot of prob lem in te t de ign, confirm ation of te t param eter and te t re ult evaluation. Th i article de cribed how to effectively detect deg radation product in the tre ing te t. [ Key w ord s] tre ing te t; mi purity; analyticalm ethod , te t) [ 2- 4] , , , , , , , , , : 0. 1~ 1m ol L- 1 , , ; 0. 1~ 1m ol L- 1 , ; , 3, , , ; 10 , 50 60 , , , pH ; , 4 500 lx, , , , , , , , , , , ( HPLC, GC, TLC) , , HPLC [ 1] , ( tre ing , 1548 Ch ine e Journal of New D rug 2008, Vol. 17 N o. 17 2008 17 17