{"id":1699,"date":"2026-04-16T01:12:48","date_gmt":"2026-04-16T01:12:48","guid":{"rendered":"https:\/\/www.thermofisher.com\/blog\/accelerating-science-in-china\/?p=1699"},"modified":"2026-04-30T08:42:45","modified_gmt":"2026-04-30T08:42:45","slug":"understanding-nitrosamine-drug-substance-related-impurities-ndsris","status":"publish","type":"post","link":"https:\/\/www.thermofisher.cn\/blog\/understanding-nitrosamine-drug-substance-related-impurities-ndsris\/","title":{"rendered":"\u7406\u89e3\u4e9a\u785d\u80fa\u7c7b\u836f\u7269\u7684\u76f8\u5173\u6742\u8d28\uff08NDSRIs\uff09"},"content":{"rendered":"\n
\"\"<\/a><\/figure>\n\n\n\n

\u7b80\u4ecb<\/strong><\/strong><\/h3>\n\n\n\n

\u4e9a\u785d\u80fa\u7c7b\u836f\u7269\u76f8\u5173\u6742\u8d28\uff08NDSRIs\uff09\u5df2\u6210\u4e3a\u5236\u836f\u884c\u4e1a\u7684\u91cd\u8981\u5173\u6ce8\u70b9\u3002\u8fd9\u4e9b\u6742\u8d28\u4e0e\u6f5c\u5728\u7684\u81f4\u764c\u98ce\u9669\u6709\u5173\uff0c\u56e0\u6b64\u5bf9\u5176\u68c0\u6d4b\u548c\u63a7\u5236\u5bf9\u4e8e\u786e\u4fdd\u836f\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u81f3\u5173\u91cd\u8981\u3002\u672c\u535a\u5ba2\u65e8\u5728\u6df1\u5165\u4ecb\u7ecdNDSRIs\u7684\u6982\u5ff5\u3001\u6765\u6e90\u3001\u76d1\u7ba1\u6307\u5357\u4ee5\u53ca\u68c0\u6d4b\u548c\u63a7\u5236\u65b9\u6cd5\u3002<\/p>\n\n\n\n

\"tablet<\/a><\/figure>\n\n\n\n

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\u836f\u54c1\u4e2dNDSRI\u7684\u6765\u6e90<\/strong><\/strong><\/h3>\n\n\n\n

NDSRI\u53ef\u901a\u8fc7\u591a\u79cd\u9014\u5f84\u5728\u836f\u54c1\u5236\u9020\u8fc7\u7a0b\u4e2d\u5f62\u6210\uff0c\u5305\u62ec\uff1a<\/p>\n\n\n\n

    \n
  1. \u4e8c\u7ea7\u6216\u4e09\u7ea7\u80fa\u4e0e\u4e9a\u785d\u5316\u5242\u53cd\u5e94\uff1a<\/strong>\u836f\u7269\u539f\u6599\u6216\u8f85\u6599\u4e2d\u7684\u4e8c\u7ea7\u6216\u4e09\u7ea7\u80fa\u53ef\u4e0e\u4e9a\u785d\u5316\u8bd5\u5242\uff08\u5982\u4e9a\u785d\u9178\u76d0\uff09\u53d1\u751f\u53cd\u5e94\uff0c\u751f\u6210NDSRIs\u3002<\/li>\n\n\n\n
  2. \u964d\u89e3\u9014\u5f84\uff1a<\/strong>\u67d0\u4e9b\u836f\u7269\u539f\u6599\u53ef\u80fd\u968f\u65f6\u95f4\u964d\u89e3\uff0c\u4ece\u800c\u751f\u6210NDSRIs\u3002<\/li>\n\n\n\n
  3. \u53d7\u6c61\u67d3\u7684\u539f\u6750\u6599\uff1a<\/strong>\u539f\u6750\u6599\u88abNDSRIs\u6216\u4e9a\u785d\u5316\u5242\u6c61\u67d3\u53ef\u80fd\u4f1a\u5c06\u8fd9\u4e9b\u6742\u8d28\u5f15\u5165\u6700\u7ec8\u4ea7\u54c1\u3002<\/li>\n\n\n\n
  4. \u4ea4\u53c9\u6c61\u67d3\uff1a<\/strong>\u5236\u9020\u8fc7\u7a0b\u4e2d\u53d1\u751f\u7684\u4ea4\u53c9\u6c61\u67d3\u4e5f\u53ef\u80fd\u5bfc\u81f4\u836f\u54c1\u4e2d\u51fa\u73b0NDSRIs\u3002<\/li>\n<\/ol>\n\n\n\n

    \u76d1\u7ba1\u6307\u5357<\/strong><\/strong><\/h3>\n\n\n\n

    \u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7b49\u76d1\u7ba1\u673a\u6784\u5df2\u53d1\u5e03\u76f8\u5173\u6307\u5357\uff0c\u4ee5\u63a7\u5236\u548c\u9650\u5236\u836f\u54c1\u4e2dNDSRIs\u7684\u542b\u91cf\u3002\u4e3b\u8981\u5185\u5bb9\u5305\u62ec\uff1a<\/p>\n\n\n\n

      \n
    1. \u98ce\u9669\u8bc4\u4f30\uff1a<\/strong>\u5236\u9020\u5546\u5fc5\u987b\u8fdb\u884c\u5168\u9762\u7684\u98ce\u9669\u8bc4\u4f30\uff0c\u4ee5\u8bc6\u522b\u6f5c\u5728\u7684NDSRIs\u6765\u6e90\u3002<\/li>\n\n\n\n
    2. \u5206<\/strong>\u6790\u68c0\u6d4b\uff1a<\/strong>\u91c7\u7528\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u5206\u6790\u65b9\u6cd5\u68c0\u6d4b\u548c\u5b9a\u91cf\u836f\u54c1\u4e2d\u7684NDSRIs\u3002<\/li>\n\n\n\n
    3. \u63a7\u5236\u7b56\u7565\uff1a<\/strong>\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5b9e\u65bd\u63a7\u5236\u7b56\u7565\uff0c\u4ee5\u51cf\u5c11NDSRIs\u7684\u751f\u6210\u3002<\/li>\n\n\n\n
    4. \u53ef\u63a5\u53d7\u6444\u5165\u91cf\uff08AI\uff09\u9650\u503c\uff1a<\/strong>\u9075\u5b88\u89c4\u5b9a\u7684NDSRIs\u53ef\u63a5\u53d7\u6444\u5165\u91cf\u9650\u503c\u4ee5\u786e\u4fdd\u60a3\u8005\u5b89\u5168\u3002\u8fd9\u5bf9NDSRIs\u6765\u8bf4\u662f\u4e00\u4e2a\u6311\u6218\uff0c\u56e0\u4e3a\u901a\u5e38\u7f3a\u4e4f\u5177\u4f53\u7684\u6bd2\u7406\u5b66\u6570\u636e\uff0c\u56e0\u6b64\u5efa\u7acbAI\u9650\u503c\u5b58\u5728\u56f0\u96be\u3002<\/li>\n<\/ol>\n\n\n\n

      \u68c0\u6d4b\u4e0e\u5206\u6790<\/strong><\/strong><\/h3>\n\n\n\n

      \u68c0\u6d4b\u548c\u5206\u6790NDSRIs\u9700\u8981\u7684\u5206\u6790\u6280\u672f\u3002\u6700\u5e38\u7528\u7684\u65b9\u6cd5\u5305\u62ec\uff1a<\/p>\n\n\n\n

        \n
      1. \u6c14\u76f8\u8272\u8c31<\/u>–<\/u>\u8d28\u8c31\u8054\u7528\uff08<\/u>GC-MS<\/u>\uff09\uff1a<\/u><\/a>GC-MS\u5bf9\u4e8e\u5206\u79bb\u548c\u9274\u5b9a\u6325\u53d1\u6027\u4e9a\u785d\u80fa\u975e\u5e38\u6709\u6548\u3002<\/li>\n\n\n\n
      2. \u6db2\u76f8\u8272\u8c31-\u8d28\u8c31\u8054\u7528\uff08LC-MS\uff09\uff1a<\/u><\/a>LC-MS\u9002\u7528\u4e8e\u975e\u6325\u53d1\u6027\u4e9a\u785d\u80fa\uff0c\u5e76\u5177\u6709\u9ad8\u7075\u654f\u5ea6\u548c\u7279\u5f02\u6027\u3002<\/li>\n\n\n\n
      3. \u9ad8\u6548\u6db2\u76f8\u8272\u8c31\uff08HPLC\uff09\uff1a<\/u><\/a>HPLC\u53ef\u4ee5\u4e0e\u5176\u4ed6\u68c0\u6d4b\u5668\u7ed3\u5408\u4f7f\u7528\uff0c\u7528\u4e8e\u5206\u6790\u4e9a\u785d\u80fa\u3002<\/li>\n\n\n\n
      4. \u79bb\u5b50\u8272\u8c31\u6cd5<\/u>\uff08<\/u>Ion Chromatography<\/u>\uff09<\/u>\uff1a<\/u><\/a>\u9002\u7528\u4e8e\u68c0\u6d4b\u4e9a\u785d\u9178\u76d0\u548c\u785d\u9178\u76d0\u79bb\u5b50\uff0c\u8fd9\u4e9b\u79bb\u5b50\u662f\u4e9a\u785d\u80fa\u5f62\u6210\u7684\u524d\u4f53\u3002<\/li>\n<\/ol>\n\n\n\n

        \u63a7\u5236\u4e0e<\/strong>\u964d\u4f4e<\/strong>\u7b56\u7565<\/a><\/strong><\/strong><\/h3>\n\n\n\n

        \u4e3a\u4e86\u63a7\u5236\u548c\u51cf\u5c11NDSRIs\u7684\u5f62\u6210\uff0c\u5236\u9020\u5546\u53ef\u4ee5\u91c7\u53d6\u591a\u79cd\u7b56\u7565\uff1a<\/p>\n\n\n\n

          \n
        1. \u5de5\u827a\u4f18\u5316\uff1a<\/strong>\u4f18\u5316\u5236\u9020\u5de5\u827a\uff0c\u5c3d\u91cf\u51cf\u5c11\u4e9a\u785d\u5316\u8bd5\u5242\u548c\u80fa\u7c7b\u7684\u4f7f\u7528\u3002\u8fd9\u4e5f\u662f\u4e00\u4e2a\u6311\u6218\uff0c\u56e0\u4e3a\u8bb8\u591a\u539f\u6599\u836f(API)\u672c\u8eab\u542b\u6709\u4e8c\u7ea7\u6216\u4e09\u7ea7\u80fa\u529f\u80fd\u56e2\u3002<\/li>\n\n\n\n
        2. \u539f<\/strong>\u6750\u6599\u8d28\u91cf\u63a7\u5236\uff1a<\/strong>\u786e\u4fdd\u539f\u6750\u6599\u4e0d\u542bNDSRIs\u3002<\/li>\n\n\n\n
        3. \u73af\u5883\u63a7\u5236\uff1a<\/strong>\u5b9e\u65bd\u73af\u5883\u63a7\u5236\u4ee5\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u3002<\/li>\n\n\n\n
        4. \u7a33\u5b9a\u6027\u7814\u7a76\uff1a<\/strong>\u5f00\u5c55\u7a33\u5b9a\u6027\u7814\u7a76\uff0c\u4ee5\u4e86\u89e3\u964d\u89e3\u8def\u5f84\u548cNDSRIs\u5f62\u6210\u7684\u53ef\u80fd\u6027\u3002<\/li>\n\n\n\n
        5. \u914d\u65b9\u8c03\u6574\uff1a<\/strong>\u8c03\u6574\u914d\u65b9\u4ee5\u66ff\u6362\u6216\u51cf\u5c11\u80fa\u7c7b\u6216\u4e9a\u785d\u5316\u8bd5\u5242\u7684\u4f7f\u7528\u3002<\/li>\n<\/ol>\n\n\n\n

          \u7ed3\u8bba<\/a><\/strong><\/strong><\/h3>\n\n\n\n

          NDSRIs\u4e3a\u5236\u836f\u884c\u4e1a\u5e26\u6765\u4e86\u91cd\u5927\u6311\u6218\uff0c\u5bf9\u836f\u54c1\u5b89\u5168\u548c\u5408\u89c4\u76d1\u7ba1\u4ea7\u751f\u5f71\u54cd\u3002\u901a\u8fc7\u4e86\u89e3NDSRIs\u7684\u6765\u6e90\u3001\u9075\u5faa\u76d1\u7ba1\u6307\u5357\uff0c\u5e76\u91c7\u7528\u5f3a\u6709\u529b\u7684\u5206\u6790\u4e0e\u63a7\u5236\u7b56\u7565\uff0c\u5236\u9020\u5546\u80fd\u591f\u6709\u6548\u7ba1\u7406\u8fd9\u4e9b\u6742\u8d28\uff0c\u786e\u4fdd\u5176\u836f\u54c1\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u968f\u7740\u5206\u6790\u6280\u672f\u7684\u4e0d\u65ad\u53d1\u5c55\u4ee5\u53ca\u6301\u7eed\u7684\u98ce\u9669\u76d1\u63a7\uff0c\u5e94\u5bf9\u4e9a\u785d\u80fa\u6742\u8d28\u95ee\u9898\u4ecd\u5c06\u662f\u4e00\u4e2a\u957f\u671f\u4e14\u52a8\u6001\u7684\u8fc7\u7a0b\u3002<\/p>\n\n\n\n

          \u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c<\/strong>\u7acb\u5373\u4e0b\u8f7d\u6211\u4eec\u5173\u4e8e\u4e9a\u785d\u80fa\u6742\u8d28\u5206\u6790\u7684\u5168\u9762\u89e3\u51b3\u65b9\u6848\u6307\u5357\uff1a\u4e9a\u785d\u80fa\u6742\u8d28\u5206\u6790\u89e3\u51b3\u65b9\u6848\u6307\u5357<\/u><\/a>\u5e76\u8bbf\u95ee\u6211\u4eec\u7684\u7f51\u7ad9\u4e9a\u785d\u80fa\u6742\u8d28\u5206\u6790<\/u><\/a>\u3002<\/p>\n\n\n\n

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