{"id":7635,"date":"2018-06-12T01:00:00","date_gmt":"2018-07-27T09:26:14","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e5%88%b0%e5%ba%95%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e7%a1%ae%e8%ae%a4%e8%af%a5%e5%81%9a%e5%93%aa%e4%ba%9b%e9%a1%b9%e7%9b%ae%e5%91%a2%ef%bc%9f\/"},"modified":"2018-07-27T17:26:15","modified_gmt":"2018-07-27T09:26:15","slug":"%e5%88%b0%e5%ba%95%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e7%a1%ae%e8%ae%a4%e8%af%a5%e5%81%9a%e5%93%aa%e4%ba%9b%e9%a1%b9%e7%9b%ae%e5%91%a2%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/7635\/","title":{"rendered":"\u5230\u5e95\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u8be5\u505a\u54ea\u4e9b\u9879\u76ee\u5462\uff1f"},"content":{"rendered":"
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\u6458\u8981\uff1a<\/strong>\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\uff0c\u5e94\u8be5\u505a\u54ea\u4e9b\u9879\u76ee\uff0c\u624d\u4e0d\u88ab\u5b98\u65b9\u6311\u6218\u5462\uff1f\u4e00\u76f4\u4ee5\u6765\u6ca1\u6709\u660e\u786e\u7684\u5b9a\u8bba\u3002\u672c\u7bc7\u6587\u7ae0\uff0c\u5c0f\u7f16\u5bf9\u5386\u7248USP\u53caFDA\u6307\u5357\u5173\u4e8e\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u7684\u5185\u5bb9\u8fdb\u884c\u5256\u6790\uff0c\u5e0c\u671b\u5f97\u51fa\u79d1\u5b66\u7684\u7ed3\u8bba\u3002<\/span><\/span><\/span><\/p>\n

\u5341\u51e0\u5e74\u7684\u836f\u5178\u8ddf\u8e2a\u7ecf\u9a8c\u8868\u660e\uff0cUSP\u6536\u8f7d\u7684\u901a\u5219\uff0c\u521a\u5f00\u59cb\u7684\u65f6\u5019\u4f1a\u5c06\u5982\u4f55\u505a\uff0c\u63a5\u53d7\u6807\u51c6\u662f\u591a\u5c11\u90fd\u89c4\u5b9a\u7684\u5f88\u8be6\u7ec6\uff0c\u4f46\u5728\u4ee5\u540e\u7684\u7248\u672c\u4fee\u8ba2\u7684\u65f6\u5019\uff0c\u6162\u6162\u7684\u4f1a\u5c06\u8fd9\u4e9b\u89c4\u5b9a\u5220\u9664\uff0c\u53d8\u6210\u7531\u4f7f\u7528\u8005\u6839\u636e\u81ea\u5df1\u7684\u5b9e\u9645\u60c5\u51b5\u8fdb\u884c\u8bc4\u4f30\u786e\u5b9a\uff0c<\/span>\u6240\u4ee5\u7814\u7a76\u4e4b\u524d\u7248\u672c\u7684\u89c4\u5b9a\u5185\u5bb9\uff0c\u8fd8\u662f\u5f88\u6709\u610f\u4e49\u7684\u3002<\/span><\/p>\n

\u9996\u5148\uff0c\u6211\u4eec\u6765\u4e86\u89e3\u4e00\u4e0bUSP\u836f\u5178\u5173\u4e8e\u300a1226\u300b\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u7ae0\u8282\u7684\u5386\u53f2\u5427\u3002\u300a1226\u300b\u836f\u5178\u65b9\u6cd5\u786e\u8ba4\u7ae0\u8282\u6700\u65e9\u662f\u88ab2006\u5e7405\u670801\u6267\u884c\u7684USP29\u6536\u8f7d\uff0c\u4f5c\u4e3a\u300a1225\u300b\u65b9\u6cd5\u9a8c\u8bc1\u7a0b\u5e8f\u7684\u8865\u5145\u3002\u7d27\u63a5\u7740\uff0c2008\u5e7412\u670801\u6267\u884c\u7684USP30\u7b2c2\u589e\u8865\u672c\uff0c2009\u5e7405\u670801\u6267\u884c\u7684USP32\u53ca2019\u5e7405\u670801\u65e5\u5373\u5c06\u6267\u884c\u7684USP42\u5747\u5bf9\u300a1226\u300b\u8fdb\u884c\u4e86\u4fee\u8ba2\uff0c\u5177\u4f53\u4fee\u8ba2\u4e86\u4ec0\u4e48\u5185\u5bb9\uff0c\u6211\u4e3a\u5927\u5bb6\u4e00\u4e00\u63ed\u6653\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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USP29<1226><\/strong>\u836f\u5178\u65b9\u6cd5\u786e\u8ba4<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u5f53\u65f6\u6536\u8f7d\u4e862\u5f20\u8868\uff0c\u8868\u4e2d\u6309\u9879\u76ee\u89c4\u5b9a\u4e86\u5177\u4f53\u9700\u8981\u5b8c\u6210\u7684\u786e\u8ba4\u9879\u76ee\u3002\u5177\u4f53\u5185\u5bb9\u5982\u4e0b\uff1a<\/span><\/p>\n

\u88681 \u539f\u6599\u836f\u53ca\u8f85\u6599\u65b9\u6cd5\u786e\u8ba4<\/span><\/p>\n

<\/span><\/p>\n\n\n\n\n\n\n\n\n\n
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\u6280\u672f<\/strong><\/span><\/span><\/p>\n<\/td>\n

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\u5206\u7c7b I<\/span><\/strong><\/p>\n

\u542b\u91cf<\/span><\/strong><\/p>\n<\/td>\n

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\u5206\u7c7b<\/span><\/strong> II<\/span><\/strong><\/p>\n

\u6709\u5173\u7269\u8d28<\/span><\/strong><\/p>\n<\/td>\n

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\u5206\u7c7b<\/span><\/strong> III<\/span><\/strong><\/p>\n

\u6eb6\u51fa\u5ea6<\/span><\/strong><\/p>\n

\u91ca\u653e\u5ea6<\/span><\/strong><\/p>\n<\/td>\n

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\u5206\u7c7b<\/span><\/strong> IV<\/span><\/strong><\/p>\n

\u9274\u522b<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

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\u5b9a\u91cf<\/span><\/p>\n<\/td>\n

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\u9650\u5ea6<\/span><\/p>\n<\/td>\n<\/tr>\n

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HPLC\/GC<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n

\u4e13\u5c5e\u6027<\/span><\/p>\n

\u5b9a\u91cf\u9650<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u68c0\u6d4b\u9650<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u5149\u8c31<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n

\u5b9a\u91cf\u9650<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u68c0\u6d4b\u9650<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u6ef4\u5b9a<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n<\/tr>\n

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TLC<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u5b9a\u91cf\u9650<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u68c0\u6d4b\u9650<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u51dd\u80f6\u7535\u6cf3<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u5b9a\u91cf\u9650<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u68c0\u6d4b\u7ebf<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/span>\u88682 \u5236\u5242\u65b9\u6cd5\u786e\u8ba4<\/span><\/p>\n

<\/span><\/p>\n\n\n\n\n\n\n\n\n\n
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\u6280\u672f<\/strong><\/span><\/span><\/p>\n<\/td>\n

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\u5206\u7c7b<\/span><\/strong> I<\/span><\/strong><\/p>\n

\u542b\u91cf<\/span><\/strong><\/p>\n<\/td>\n

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\u5206\u7c7b <\/span><\/strong>II<\/span><\/strong><\/p>\n

\u6709\u5173\u7269\u8d28<\/span><\/strong><\/p>\n<\/td>\n

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\u5206\u7c7b <\/span><\/strong>III<\/span><\/strong><\/p>\n

\u6eb6\u51fa\u5ea6<\/span><\/strong>\u91ca\u653e\u5ea6<\/span><\/strong><\/p>\n<\/td>\n

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\u5206\u7c7b<\/span><\/strong> IV<\/span><\/strong><\/p>\n

\u9274\u522b<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

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\u5b9a\u91cf<\/span><\/p>\n<\/td>\n

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\u9650\u5ea6<\/span><\/p>\n<\/td>\n<\/tr>\n

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HPLC\/GC<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n

\u4e13\u5c5e\u6027<\/span><\/p>\n

\u7ebf\u6027<\/span><\/p>\n

\u8303\u56f4<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n

\u4e13\u5c5e\u6027<\/span><\/p>\n

\u5b9a\u91cf\u9650<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u68c0\u6d4b\u9650<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n

\u7ebf\u6027<\/span><\/p>\n

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\u5b9a\u91cf\u9650<\/span><\/p>\n<\/td>\n

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\u68c0\u6d4b\u9650<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u6ef4\u5b9a<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n

\u7ebf\u6027<\/span><\/p>\n

\u8303\u56f4<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n<\/tr>\n

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TLC<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u5b9a\u91cf\u9650<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u68c0\u6d4b\u9650<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u51dd\u80f6\u7535\u6cf3<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u5b9a\u91cf\u9650<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n

\u68c0\u6d4b\u9650<\/span><\/p>\n<\/td>\n

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\u2014<\/span><\/p>\n<\/td>\n

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\u4e13\u5c5e\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/span>\u4ece\u4e0a\u8868\u6211\u4eec\u53d1\u73b0\uff0c\u5236\u5242\u542b\u91cf\uff08HPLC\/GC\uff0c\u5149\u8c31\uff0c\u6ef4\u5b9a\uff09\u6bd4\u539f\u6599\u836f\u53ca\u8f85\u6599\u7684\u542b\u91cf\uff08HPLC\/GC\uff0c\u5149\u8c31\uff0c\u6ef4\u5b9a\uff09\u786e\u8ba4\u7684\u9879\u76ee\u8fd8\u4e0d\u540c\uff0c\u591a\u51fa\u4e86\u7ebf\u6027\u53ca\u8303\u56f4\u4e24\u4e2a\u9879\u76ee\uff0c\u53ef\u80fd\u662f\u8003\u8651\u5230\u5236\u5242\u7684\u4e0d\u540c\u89c4\u683c\u5427\u3002\u6eb6\u51fa\u5ea6\u53ca\u91ca\u653e\u5ea6\u662f\u5236\u5242\u68c0\u6d4b\u9879\u76ee\uff0c\u6240\u4ee5\u5728\u539f\u6599\u836f\u53ca\u8f85\u6599\u7684\u8868\u683c\u4e2d\u5c31\u76f4\u63a5\u6760\u6389\u4e86\u3002<\/span><\/p>\n

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USP30<1226><\/strong>\u836f\u5178\u65b9\u6cd5\u786e\u8ba4<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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USP30\u5df2\u7ecf\u5c06USP29\u89c4\u5b9a\u7684\u8868\u683c\u53ca\u5176\u5185\u5bb9\u5168\u90e8\u90fd\u5220\u9664\u4e86\uff0c\u5e76\u4e14\u89c4\u5b9a\uff0c\u786e\u8ba4\u7684\u5e7f\u5ea6\u53ca\u6df1\u5ea6\u7531\u5b9e\u9a8c\u5ba4\u4eba\u5458\u7684\u7ecf\u9a8c\u53ca\u6c34\u5e73\uff0c\u65b9\u6cd5\u7c7b\u578b\u53ca\u5176\u76f8\u5173\u8bbe\u5907\u6216\u4eea\u5668\u3001\u5177\u4f53\u6536\u8f7d\u7684\u5206\u6790\u7a0b\u5e8f\u51b3\u5b9a\u3002\u540c\u65f6\u89c4\u5b9a\u4e13\u5c5e\u6027\u662f\u836f\u5178\u65b9\u6cd5\u662f\u5426\u9002\u7528\u7684\u5173\u952e\u53c2\u6570\uff0c\u6742\u8d28\u68c0\u6d4b\u65f6\uff0c\u68c0\u6d4b\u9650\u4e5f\u662f\u8bc4\u4f30\u836f\u5178\u65b9\u6cd5\u9002\u7528\u6027\u7684\u6709\u6548\u8bc4\u4f30\u53c2\u6570\u3002<\/span>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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USP32<1226>\u836f\u5178\u65b9\u6cd5\u786e\u8ba4<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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USP32\u867d\u7136\u5bf9\u300a1226\u300b\u6709\u505a\u4fee\u8ba2\uff0c\u4f46\u90fd\u662f\u4e00\u4e0b\u63cf\u8ff0\u6027\u7684\u4fee\u8ba2\uff0c\u4e0d\u6d89\u53ca\u6839\u672c\u5185\u5bb9\u3002<\/span><\/p>\n


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PF41(5)<1467> Residual Solvents Verification of Compendial Procedures and Validation of Alternative Procedures<\/strong><\/section>\n<\/section>\n

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PF 41(5)<\/span>\u6536\u8f7d\u7684<\/span>\u300a<\/span>1467<\/span>\u300b\u6b8b\u7559\u6eb6\u5242\u836f\u5178\u65b9\u6cd5\u786e\u8ba4\u53ca\u66ff\u4ee3\u65b9\u6cd5\u9a8c\u8bc1\uff0c\u867d\u7136\u6ca1\u6709\u88ab<\/span>USP41<\/span>\u7b2c<\/span>1<\/span>\u589e\u8865\u672c\u6536\u8f7d\uff0c\u8ddf\u6b8b\u7559\u6eb6\u5242\u65b9\u6cd5\u786e\u8ba4\u672c\u8eab\u7684\u5c40\u9650\u6027\u6709\u5173\uff0c\u4f17\u6240\u5468\u77e5\uff0c\u7531\u4e8e\u5404\u751f\u4ea7\u5546\u5de5\u827a\u4e0d\u540c\uff0c\u836f\u5178\u4e13\u8bba\u5f88\u5c11\u6536\u8f7d\u6b8b\u7559\u6eb6\u5242\u65b9\u6cd5\uff0c\u6240\u4ee5\u5c31\u66f4\u8c08\u4e0d\u4e0a\u6b8b\u7559\u6eb6\u5242\u65b9\u6cd5\u786e\u8ba4\u4e86\u3002\u4f46\u91cc\u9762\u5217\u7684\u5173\u4e8e\u65b9\u6cd5\u786e\u8ba4\u5e94\u505a\u7684\u9879\u76ee\u4ee3\u8868\u4e86\u6700\u65b0\u7684<\/span>USP<\/span>\u5173\u4e8e\u6b8b\u7559\u6eb6\u5242\u786e\u8ba4\u5e94\u5b8c\u6210\u7684\u9879\u76ee\uff0c\u9488\u5bf9\u4e8e\u6709\u5173\u7269\u8d28\u65b9\u6cd5\u786e\u8ba4\u8fd8\u662f\u5f88\u5177\u6709\u53c2\u8003\u610f\u4e49\u7684\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u9a8c\u8bc1<\/span>\/<\/span>\u786e\u8ba4\u9879\u76ee<\/span><\/p>\n<\/td>\n

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\u836f\u5178\u65b9\u6cd5\u786e\u8ba4<\/span><\/p>\n<\/td>\n

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\u66ff\u6362\u65b9\u6cd5\u9a8c\u8bc1<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u9650\u5ea6\u65b9\u6cd5<\/span><\/p>\n<\/td>\n

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\u5b9a\u91cf\u65b9\u6cd5<\/span><\/p>\n<\/td>\n

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\u9650\u5ea6\u65b9\u6cd5<\/span><\/p>\n<\/td>\n

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\u5b9a\u91cf\u65b9\u6cd5<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u51c6\u786e\u5ea6<\/span><\/p>\n<\/td>\n

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\u7cbe\u5bc6\u5ea6\uff08\u91cd\u590d\u6027\uff09<\/span><\/p>\n<\/td>\n

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\u7ebf\u6027<\/span><\/p>\n<\/td>\n

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\u00d7<\/span><\/p>\n<\/td>\n

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\u221a<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u8303\u56f4<\/span><\/p>\n<\/td>\n

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\u00d7<\/span><\/p>\n<\/td>\n

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\u7531\u51c6\u786e\u5ea6\u53ca\u7cbe\u5bc6\u5ea6\u786e\u5b9a<\/span><\/p>\n<\/td>\n

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\u00d7<\/span><\/p>\n<\/td>\n

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\u7531\u51c6\u786e\u5ea6\u53ca\u7cbe\u5bc6\u5ea6\u786e\u5b9a<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u4e2d\u95f4\u7cbe\u5bc6\u5ea6<\/span><\/p>\n<\/td>\n

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\u00d7<\/span><\/p>\n<\/td>\n

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\u00d7<\/span><\/p>\n<\/td>\n

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\u00d7<\/span><\/p>\n<\/td>\n

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\u221a<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u6eb6\u6db2\u7a33\u5b9a\u6027<\/span><\/p>\n<\/td>\n

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\u221a<\/span><\/p>\n<\/td>\n

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\u221a<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u8010\u7528\u6027<\/span><\/p>\n<\/td>\n

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\u00d7<\/span><\/p>\n<\/td>\n

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\u221a<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u4e0a\u8868\u8868\u660e\uff0c\u836f\u5178\u9650\u5ea6\u65b9\u6cd5\u786e\u8ba4\uff0c\u5e94\u5b8c\u6210\u4e13\u5c5e\u6027\uff0c\u68c0\u6d4b\u9650\uff0c\u6eb6\u6db2\u7a33\u5b9a\u6027\u9879\u76ee\uff0c\u836f\u5178\u5b9a\u91cf\u65b9\u6cd5\u786e\u8ba4\uff0c\u5e94\u5b8c\u6210\u4e13\u5c5e\u6027\uff0c\u5b9a\u91cf\u9650\uff0c\u51c6\u786e\u5ea6\uff0c\u7cbe\u5bc6\u5ea6\uff08\u91cd\u590d\u6027\uff09\uff0c\u6eb6\u6db2\u7a33\u5b9a\u6027\u9879\u76ee\u3002\u5927\u5bb6\u6ce8\u610f\u4e86\uff0c\u8fd9\u91cc\u90fd\u89c4\u5b9a\u4e86\u8fdb\u884c\u6eb6\u6db2\u7a33\u5b9a\u6027\u7684\u7814\u7a76\uff0c\u8fd9\u8ddf\u5373\u5c06\u6267\u884c\u7684USP42\u7248\u300a1226\u300b\u836f\u5178\u65b9\u6cd5\u786e\u8ba4\u7ae0\u8282\u589e\u52a0\u201c\u4f7f\u7528\u8005\u6709\u8d23\u4efb\u5bf9\u8fd0\u884c\u671f\u95f4\u6837\u54c1\u6eb6\u6db2\u53ca\u6807\u51c6\u6eb6\u6db2\u7684\u6eb6\u6db2\u7a33\u5b9a\u6027\u8fdb\u884c\u8bc4\u4f30\u201d\u662f\u4e00\u76f4\u7684\u3002<\/span><\/p>\n

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USP42\u300a1226\u300b\u836f\u5178\u65b9\u6cd5\u786e\u8ba4<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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USP42\u4e8e2019.05.01\u6267\u884c\uff0c\u5c06\u5bf9\u300a1226\u300b\u836f\u5178\u65b9\u6cd5\u786e\u8ba4\u8fdb\u884c\u4fee\u8ba2\uff0c\u9664\u4e86\u4e4b\u524d\u89c4\u5b9a\u7684\uff0c\u836f\u5178\u65b9\u6cd5\u786e\u8ba4\u7684\u5e7f\u5ea6\u53ca\u6df1\u5ea6\u7531\u5b9e\u9a8c\u5ba4\u4eba\u5458\u7684\u7ecf\u9a8c\u53ca\u6c34\u5e73\uff0c\u65b9\u6cd5\u7c7b\u578b\u53ca\u5176\u76f8\u5173\u8bbe\u5907\u6216\u4eea\u5668\u3001\u5177\u4f53\u6536\u8f7d\u7684\u5206\u6790\u7a0b\u5e8f\u51b3\u5b9a\u3002\u540c\u65f6\u89c4\u5b9a\u4e13\u5c5e\u6027\u662f\u836f\u5178\u65b9\u6cd5\u662f\u5426\u9002\u7528\u7684\u5173\u952e\u53c2\u6570\uff0c\u6b64\u5916\u68c0\u6d4b\u9650\uff0c\u5b9a\u91cf\u9650\uff0c\u7cbe\u5bc6\u5ea6\u4e5f\u662f\u8bc4\u4f30\u836f\u5178\u65b9\u6cd5\u9002\u7528\u6027\u7684\u6709\u6548\u8bc4\u4f30\u53c2\u6570\u3002\u540c\u65f6\u589e\u52a0\u4e86\u4f7f\u7528\u8005\u6709\u8d23\u4efb\u5bf9\u8fd0\u884c\u671f\u95f4\u6837\u54c1\u6eb6\u6db2\u53ca\u6807\u51c6\u6eb6\u6db2\u7684\u6eb6\u6db2\u7a33\u5b9a\u6027\u8fdb\u884c\u8bc4\u4f30\u3002<\/span>
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\u5206\u6790\u5b8c\u4e86USP\u7684\u5185\u5bb9\uff0c\u63a5\u4e0b\u6765\uff0c\u6211\u4eec\u6765\u5206\u6790\u4e00\u4e0bFDA\u5173\u4e8e\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u7684\u5177\u4f53\u89c4\u5b9a\u5427\u3002<\/span><\/p>\n

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FDA\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5357\uff082008\u5e74\uff09<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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2008\u5e74FDA\u9881\u5e03\u7684\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5357\u4e2d\u660e\u786e\u89c4\u5b9a\uff0c\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u9700\u5bf9\u4e13\u5c5e\u6027\u3001\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\u53ca\u6eb6\u6db2\u7a33\u5b9a\u8fdb\u884c\u786e\u8ba4\u3002<\/span>
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FDA\u6307\u5357Analytical Procedures and Methods Validation for Drugs and Biologics\uff082015\u5e74\uff09<\/strong><\/section>\n<\/section>\n

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\u836f\u5178\u65b9\u6cd5\u786e\u8ba4\u7684\u5e7f\u5ea6\u53ca\u6df1\u5ea6\u5e94\u5728\u7a0b\u5e8f\u91cc\u89c4\u5b9a\uff08\u4f8b\u5982\uff1a\u4e13\u5c5e\u6027\uff0cLOD\uff0c LOQ\uff0c\u7cbe\u5bc6\u5ea6\uff0c\u51c6\u786e\u5ea6\uff09\u2026\u2026<\/span>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u5982\u679c\u6ca1\u6709\u53d1\u751f\u504f\u5dee\uff0c\u8010\u7528\u6027\u53ef\u4ee5\u4e0d\u7528\u7814\u7a76\u3002<\/span><\/p>\n


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\u5206\u6790\u4e86\u8fd9\u4e48\u591a\uff0c\u76f8\u4fe1\u5927\u5bb6\u5fc3\u91cc\u5df2\u7ecf\u6709\u8c31\u4e86\uff0c\u90a3\u63a5\u4e0b\u6765\uff0c\u6211\u4eec\u6765\u603b\u7ed3\u4e00\u4e0b\uff0c\u836f\u5178\u65b9\u6cd5\u786e\u8ba4\u5e94\u8be5\u505a\u7684\u9879\u76ee\uff1a<\/span><\/p>\n

\u542b\u91cf\uff1a\u4e13\u5c5e\u6027\u3001\u7cbe\u5bc6\u5ea6\uff08\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\uff09\u3001\u51c6\u786e\u5ea6\u3001\u6eb6\u6db2\u7a33\u5b9a\u6027\uff1b<\/span><\/p>\n

\u6709\u5173\u7269\u8d28\uff08\u5b9a\u6027\uff09\uff1a\u4e13\u5c5e\u6027\u3001\u68c0\u6d4b\u9650\u3001\u6eb6\u6db2\u7a33\u5b9a\u6027\uff1b<\/span><\/p>\n

\u6709\u5173\u7269\u8d28\uff08\u5b9a\u91cf\uff09\uff1a\u4e13\u5c5e\u6027\u3001\u5b9a\u91cf\u9650\u3001\u7cbe\u5bc6\u5ea6\uff08\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\uff09\u3001\u51c6\u786e\u5ea6\u3001\u6eb6\u6db2\u7a33\u5b9a\u6027\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u4ee5\u4e0a\u4ec5\u4ee3\u8868\u4f5c\u8005\u4e2a\u4eba\u89c2\u70b9\u3002<\/span><\/p>\n

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\u6392\u7248\uff1a\u6885\u5e0c<\/span><\/strong><\/span><\/p>\n

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\u5e7f\u800c\u544a\u4e4b<\/section>\n<\/section>\n<\/section>\n
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\u2299 <\/span>\u540c\u5199\u610f\u57f9\u8bad\uff1a<\/span><\/strong><\/p>\n

\u65b0\u836f\u4e2d\u7f8e\u53cc\u62a5\u4e4b\u6cd5\u89c4\u628a\u63a7\u4e0e\u7533\u62a5\u5b9e\u8df5<\/span><\/a><\/p>\n

\u6ce8\u5c04\u5242\u4e00\u81f4\u6027\u8bc4\u4ef7\u653f\u7b56\u6cd5\u89c4\u4e0e\u5173\u952e\u6280\u672f<\/a><\/span><\/p>\n

\u5c0f\u5206\u5b50\u521b\u65b0\u836f\u7269\u53d1\u73b0\u2014\u2014\u7406\u8bba\u3001\u5b9e\u8df5\u3001\u8fc7\u7a0b\u4e0e\u5c55\u671b<\/a><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\"\u5230\u5e95\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u8be5\u505a\u54ea\u4e9b\u9879\u76ee\u5462\uff1f\"<\/a><\/p>\n

\n


<\/p>\n

\u836f\u4e8b\u7eb5\u6a2a\u662f\u4e00\u4e2a\u5f00\u653e\uff0c\u7531\u81ea\u613f\u8005\u7ec4\u6210\u7684\u56e2\u4f53\uff0c\u73b0\u6709\u6210\u545840\u540d\uff0c\u5206\u522b\u4e3aVoyager88\uff08\u9b4f\u5229\u519b\uff09\uff0c\u96f7\u8bfa\u5c9b\uff0c\u4e09\u5206\u8bdd\uff0cHerman\uff0c\u6885\u5e0c\uff0c\u6587\u7af9\uff0cduke\uff0cyhqqqqq\uff0c\u5360\u5c0f\u5175\uff0c\u98ce\u4e00\u6837\u7684\u5c4e\u58f3\u90ce\uff0c\u9526\u5fc3\u7ee3\u53e3\uff0cflydp511\uff0cChololate\uff0c\u4e91\u6c34\u9053\u4eba\uff0c\u9621\u4e0a\u964c\u964c\uff0c\u591a\u5df4\u80fa\uff0c\u745c\u513f\uff0cKailyn\uff0cSmall fish\uff0c\u5b50\u708e\uff0c\u514b\u683c\u83ab\uff0cVicky\uff0c\u4e07\u4e8b\u7686\u4e3a\u7a7a\uff0cPandada\uff0c\u83ab\u5306\u5306\uff0cSophia \uff0c\u4f9d\u7136\u7279\u96f7\u897f\uff0c\u5076\u9635\u96e8\uff0cAimee\uff0c\u4ed6\u5c71\u4e4b\u77f3\uff0c\u5510\u5c0f\u7396\uff0c\u96f6\u4e0b274\u2103\uff0cGloria\uff0c\u6ce2\u6ce2\uff0cBreathless\uff0cD.1\u53f7\uff0c\u80e1\u4e0d\u559c\uff0c Helen\uff0c\u843d\u843d\uff0cHERMIT\u3002\u6b22\u8fce\u6709\u5fd7\u4e4b\u58eb\u52a0\u5165\u6211\u4eec\u56e2\u961f\u3002\u6295\u7a3f\u3001\u5408\u4f5c\u3001\u52a0\u4e13\u4e1a\u7fa4\u8bf7\u52a0\u5fae\u4fe1442015666\uff0c\u836f\u4e8b\u7eb5\u6a2a\u4e8c\u5343\u4ebaQQ\u7fa422711855\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n

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