{"id":59985,"date":"2018-10-23T01:00:00","date_gmt":"2018-12-07T02:52:18","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/9768e3993f\/"},"modified":"2018-12-07T10:52:24","modified_gmt":"2018-12-07T02:52:24","slug":"9768e3993f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/59985\/","title":{"rendered":"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5"},"content":{"rendered":"
\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

\u63ed\u5bc6\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5
<\/p>\n

\n
\n
\n


<\/p>\n

2005\u5e74\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08USFDA\uff09\u6307\u51fa\uff0c\u5728\u533b\u836f\u884c\u4e1a\u4f7f\u7528TOC\u65b9\u6cd5\u6765\u68c0\u6d4b\u6e05\u6d01\u8fc7\u7a0b\u540e\u7684\u6b8b\u7559\u7269\u662f\u53ef\u884c\u7684\u3002\u7136\u800c\u81ea1993\u5e74\u5f00\u59cb\uff0c\u5236\u836f\u884c\u4e1a\u4e00\u76f4\u4ee5\u6765\u90fd\u4f7f\u7528\u4ea7\u54c1\u4e13\u5c5e\u6027\u65b9\u6cd5\uff08HPLC\uff0cELISA\uff09\u6765\u68c0\u6d4b\u6b8b\u7559\u7269\uff0c\u6240\u4ee5\u5982\u4f55\u4f7f\u7528TOC\u65b9\u6cd5\u5efa\u7acb\u4e00\u4e2a\u5b8c\u6574\u7b80\u4fbf\u7684\u6e05\u6d01\u9a8c\u8bc1\u89c4\u7a0b\u5462\uff1f\u5236\u836f\u884c\u4e1a\u7684\u5c0f\u4f19\u4f34\u4eec\uff0c\u4e5f\u8bb8\u90fd\u60f3\u8981\u5bf9TOC\u6cd5\u6709\u4e00\u4e2a\u7cfb\u7edf\u6df1\u5165\u7684\u4e86\u89e3\u3002<\/span><\/p>\n

 <\/p>\n

\u4e2d\u56fd2010\u5e74\u65b0\u7248GMP\u8981\u6c42\u6240\u6709\u5236\u836f\u4f01\u4e1a\u9700\u8981\u5bf9\u751f\u4ea7\u8bbe\u5907\u8fdb\u884c\u6e05\u6d01\u9a8c\u8bc1\uff0c\u603b\u6709\u673a\u78b3TOC \uff08Total Organic Carbon\uff09\u5206\u6790\u662f\u975e\u5e38\u9002\u7528\u4e8e\u6e05\u6d01\u9a8c\u8bc1\u7684\u5206\u6790\u65b9\u6cd5\u3002<\/strong>\u4e0e\u4f20\u7edf\u7684HPLC\u65b9\u6cd5\u76f8\u6bd4\u8f83\uff0cTOC\u6cd5\u7684\u7075\u654f\u5ea6\u66f4\u9ad8\uff0c\u5bf9\u4e8e\u5c11\u6570\u4e0d\u6eb6\u4e8e\u6c34\u7684\u6709\u673a\u5316\u5408\u7269\u4e5f\u80fd\u68c0\u6d4b\u5230\u3002\u800c\u4e14\u9a8c\u8bc1\u8fc7\u7a0b\u7b80\u5355\u65b9\u4fbf\uff0c\u65e0\u9700\u8bbe\u7f6e\u5176\u4ed6\u53c2\u6570\u3002<\/strong><\/span><\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n
\n

\u9a8c\u8bc1\u6982\u8ff0<\/p>\n<\/section>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/span><\/section>\n

\n
<\/section>\n
<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

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

\u4e2d\u836f\u63d0\u53d6\u8f66\u95f4\u3001\u4e2d\u836f\u5236\u5242\u8f66\u95f4\uff0c\u4ee5\u53ca\u5171\u7ebf\u751f\u4ea7\u591a\u4e2a\u54c1\u79cd\u7684\u751f\u4ea7\u8bbe\u5907\uff0c\u4e3a\u4e86\u4fdd\u8bc1\u6700\u5927\u9650\u5ea6\u964d\u4f4e\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u6c61\u67d3\u53ca\u4ea4\u53c9\u6c61\u67d3\u7b49\u98ce\u9669\uff0c\u6839\u636eGMP\uff082010\u5e74\u7248\uff09\u7684\u8981\u6c42\uff0c\u5fc5\u987b\u8981\u5236\u5b9a\u5171\u7ebf\u751f\u4ea7\u8bbe\u5907\u6e05\u6d17\u9a8c\u8bc1\u65b9\u6848\u3002\u7531\u6b64\u53ef\u89c1\u6e05\u6d01\u9a8c\u8bc1\u7684\u91cd\u8981\u6027\u3002
<\/span><\/p>\n

 <\/span><\/p>\n

\u5bf9\u5bb9\u6613\u64e6\u62ed\u4e14\u8868\u9762\u5e73\u6574\u7684\u8bbe\u5907\uff0c\u91c7\u7528\u68c9\u7b7e\u64e6\u62ed\u6cd5\uff1b\u5bf9\u4e0d\u6613\u64e6\u62ed\u53d6\u6837\u7684\u8bbe\u5907\u53ca\u7ba1\u8def\uff0c\u91c7\u7528\u6dcb\u6d17\u6cd5\u3002\u6839\u636e\u8bbe\u5907\u7684\u5177\u4f53\u60c5\u51b5\uff0c\u786e\u5b9a\u53ef\u64cd\u4f5c\u7684\u6e05\u6d17\u65b9\u6cd5\uff0c\u8981\u6839\u636e\u4e0d\u540c\u7684\u6e05\u6d17\u65b9\u6cd5\uff0c\u901a\u8fc7\u6d4b\u5b9a\u5fae\u751f\u7269\u9650\u5ea6\u548c\u603b\u6709\u673a\u78b3\u786e\u5b9a\u6b8b\u7559\u6c61\u67d3\u7269\u7684\u9650\u5ea6\u3002 <\/strong><\/span><\/p>\n

 <\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n


<\/p>\n

\u8bbe\u5907\u6e05\u6d17\u4f7f\u7528\u64e6\u62ed\u6cd5\u8fdb\u884c\u6e05\u6d17\u9a8c\u8bc1\u7684\uff0c\u76f8\u5e94\u7684\u6b8b\u7559\u7269\u68c0\u67e5\uff0c\u4f7f\u7528\u68c9\u7b7e\u64e6\u62ed\u6cd5\u8fdb\u884c\u91c7\u96c6\u68c0\u67e5\u8bd5\u6837\uff0c\u52a0\u603b\u6709\u673a\u78b3\u68c0\u67e5\u7528\u6c34\u6eb6\u89e3\u7a00\u91ca\u540e\u6d4b\u5b9a\u603b\u6709\u673a\u78b3\uff1b\u8bbe\u5907\u6e05\u6d17\u4f7f\u7528\u6dcb\u6d17\u6cd5\u8fdb\u884c\u6e05\u6d17\u9a8c\u8bc1\u7684\uff0c\u76f8\u5e94\u7684\u6b8b\u7559\u7269\u68c0\u67e5\uff0c\u91c7\u96c6\u6dcb\u6d17\u6db2\u4f5c\u4e3a\u68c0\u67e5\u8bd5\u6837\u6d4b\u5b9a\u603b\u6709\u673a\u78b3\u3002 <\/span><\/p>\n

 <\/span><\/p>\n

\u901a\u8fc7\u9a8c\u8bc1\u8be5\u5206\u6790\u65b9\u6cd5\u7684\u7cfb\u7edf\u9002\u7528\u6027\u3001\u7ebf\u6027\u3001\u51c6\u786e\u5ea6\u3001\u91cd\u590d\u6027\uff0c\u786e\u8ba4\u8be5\u65b9\u6cd5\u9002\u5408\u4e8e\u8bbe\u5907\u6e05\u6d17\u9a8c\u8bc1\u7684\u68c0\u6d4b\u8981\u6c42\uff0c\u53d6\u6837\u56de\u6536\u7387\u9a8c\u8bc1\u53d6\u6837\u65b9\u6cd5\u7684\u6709\u6548\u6027\u3002 <\/strong><\/span><\/p>\n

  <\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n
\n

\u9a8c\u8bc1\u76ee\u7684<\/p>\n<\/section>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/span><\/section>\n

\n
<\/section>\n
<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

\u901a\u8fc7TOC\u6cd5\u7684\u9a8c\u8bc1\uff0c\u786e\u4fdd\u8be5\u65b9\u6cd5\u80fd\u591f\u51c6\u786e\u53ef\u9760\u5730\u68c0\u6d4b\u51fa\u5171\u7ebf\u751f\u4ea7\u8bbe\u5907\u6e05\u6d17\u540e\u7684\u6b8b\u7559\u7684\u6c61\u67d3\u7269\uff0c\u80fd\u591f\u7b26\u5408\u9884\u671f\u7684\u9650\u5ea6\u6807\u51c6\u3002\u8fd9\u662f\u6bcf\u4e00\u4f4d\u5236\u836f\u884c\u4e1a\u7684\u540c\u4ec1\u90fd\u9700\u8981\u6ce8\u610f\u7684\u3002<\/span><\/p>\n

 <\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n
\n

\u9a8c\u8bc1\u8303\u56f4<\/p>\n<\/section>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/span><\/section>\n

\n
<\/section>\n
<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

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

\u9002\u7528\u4e8e\u4e2d\u836f\u63d0\u53d6\u8f66\u95f4\u3001\u4e2d\u836f\u5236\u5242\u8f66\u95f4\u7b49\u5171\u7ebf\u751f\u4ea7\u76f8\u5173\u8bbe\u5907\u6e05\u6d17\u540e\uff0c\u91c7\u96c6\u6837\u54c1\u7684TOC\u6d4b\u5b9a\u65b9\u6cd5\u7684\u9a8c\u8bc1\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u6240\u4ee5\uff0cTOC\u65b9\u6cd5\u8fdb\u884c\u6e05\u6d01\u9a8c\u8bc1\uff0c\u5728\u533b\u836f\u548c\u751f\u7269\u5236\u836f\u884c\u4e1a\u91cc\uff0c\u5230\u5e95\u5e94\u8be5\u600e\u6837\u5b9a\u4e49\u5462\uff1f<\/span><\/p>\n

 <\/p>\n

\u25c6 <\/span>\u6839\u636e\u6e05\u6d01\u8fc7\u7a0b\u800c\u975e\u4ea7\u54c1\u7b80\u5316\u9a8c\u8bc1\u65b9\u6cd5\uff1b<\/span><\/p>\n

\u25c6 <\/span>\u5feb\u901f\u8bc4\u4f30\u6e05\u6d01\u8fc7\u7a0b\u7684\u6e05\u6d01\u80fd\u529b\uff1b<\/span><\/p>\n

\u25c6 <\/span>\u901a\u8fc7\u64e6\u62ed\u548c\u6dcb\u6d17\u53d6\u6837\u6cd5\uff0c\u4f18\u5316\u5173\u952e\u6e05\u6d01\u53c2\u6570\uff08TACT\uff0c\u5373\u6e29\u5ea6\u3001\u52a8\u4f5c\u3001\u6d53\u5ea6\u4e0e\u65f6\u95f4\uff09\uff1b<\/span><\/p>\n

\u25c6 <\/span>\u4f30\u91cf\u6700\u574f\u7684\u60c5\u5f62\u4ee5\u53ca\u6210\u5206\u590d\u6742\u7684\u5316\u5408\u7269\uff0c\u4f8b\u5982\u6e05\u6d01\u5242\uff1b<\/span><\/p>\n

\u25c6 <\/span>\u52a0\u5feb\u4ea7\u54c1\u66f4\u6362\u901f\u5ea6\uff0c\u66f4\u597d\u5730\u6309\u8ba1\u5212\u751f\u4ea7\u3002<\/span><\/p>\n

 <\/span><\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n
\n

TOC\u6cd5\u7684\u72ec\u7279\u4f18\u52bf<\/p>\n<\/section>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/span><\/section>\n

\n
<\/section>\n
<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

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

\u5bf9\u4e8eTOC\u6cd5\u6765\u8bf4\uff0c\u5c06\u6709\u673a\u7269\u8bbe\u4e3a\u4e13\u5c5e\u7269\u8d28\u65f6\uff0c\u65e0\u8bba\u5176\u6765\u6e90\u662f\u4ea7\u54c1\u3001\u6e05\u6d01\u5242\u3001\u5316\u5b66\u54c1\u3001\u6eb6\u5242\uff0c\u8fd8\u662f\u526f\u4ea7\u7269\u53ca\u5fae\u751f\u7269\u6c61\u67d3\uff0c\u8981\u5224\u65ad\u51fa\u4efb\u4f55\u6b8b\u7559\u7269\u8d28\u662f\u5426\u5b58\u5728\uff0c\u90fd\u80fd\u591f\u5730\u5f88\u597d\u5b8c\u6210\u8fd9\u4e00\u4efb\u52a1\u3002\u53ea\u8981\u5176\u5206\u5b50\u7ed3\u6784\u4e2d\u5305\u542b\u78b3\uff0c\u5c31\u80fd\u591f\u68c0\u6d4b\u51fa\u4efb\u4f55\u7684\u6d3b\u6027\u5236\u836f\u6210\u5206\u6216\u8005\u6e05\u6d01\u7528\u7684\u6b8b\u7559\u7269\u8d28\u3002\u800c\u68c0\u6d4b\u7ed3\u679c\u5fc5\u987b\u4f4e\u4e8e\u76ee\u6807\u5316\u5408\u7269\u7269\u7684\u9650\u5ea6\uff0c\u63d0\u9ad8\u4e86\u6e05\u6d01\u9a8c\u8bc1\u7684\u4e25\u683c\u6027\u3002<\/strong><\/span><\/p>\n

 <\/span><\/p>\n

<\/span><\/strong>TOC\u6cd5\u5df2\u7ecf\u9010\u6e10\u88ab\u5236\u836f\u884c\u4e1a\u6240\u63a5\u53d7\uff0c\u6574\u4e2a\u884c\u4e1a\u7684\u6e05\u6d01\u9a8c\u8bc1\u7684\u4e25\u683c\u6027\u5f97\u5230\u4e86\u663e\u8457\u63d0\u9ad8\uff0c\u4e5f\u8d8a\u6765\u8d8a\u7b26\u5408\u884c\u4e1a\u7684\u6574\u4f53\u8981\u6c42\u3002TOC\u6cd5\u7684\u666e\u9002\u6027\uff0c\u4e3a\u5236\u836f\u4f01\u4e1a\u8282\u7701\u4e86\u65f6\u95f4\u548c\u4eba\u529b\u6210\u672c\u3002\u79d1\u5b66\u3001\u5408\u7406\u3001\u53ef\u884c\u7684\u6e05\u6d01\u9a8c\u8bc1\u8fc7\u7a0b\uff0c\u786e\u4fdd\u4e86\u836f\u54c1\u5b89\u5168\u751f\u4ea7\u6240\u9700\u8981\u7684\u6e05\u6d01\u5ea6\u3002<\/strong><\/span><\/p>\n


<\/strong><\/p>\n


<\/p>\n

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

\n
\n
\n
\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n
\n

TOC\u6cd5\u5b66\u4e60\u7b14\u8bb0<\/p>\n<\/section>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/span><\/section>\n

\n
<\/section>\n
<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

\u7b2c\u4e00\u7ae0\u3000TOC\u57fa\u7840\u77e5\u8bc6<\/span><\/strong><\/p>\n

\u4e00\u3001\u4ec0\u4e48\u662fTOC\uff1f<\/p>\n

\u4e8c\u3001\u4e3a\u4ec0\u4e48\u5728\u6e05\u6d01\u9a8c\u8bc1\u548c\u5e38\u89c4\u7684\u6e05\u6d01\u76d1\u6d4b\u4e2d\u4f7f\u7528TOC\uff1f<\/p>\n

\u4e09\u3001\u6e05\u6d01\u9a8c\u8bc1\u4e2d\u7684TOC\u7684\u5e94\u7528<\/p>\n

\u56db\u3001\u4f55\u65f6\u53ef\u4f7f\u7528TOC\u6d4b\u5b9a<\/p>\n

\u4e94\u3001TOC\u6cd5\u4e0e\u5e38\u7528\u5206\u6790\u65b9\u6cd5\u7684\u6bd4\u8f83<\/p>\n

 <\/p>\n

\u7b2c\u4e8c\u7ae0\u3000HPLC\u4e0eTOC\u65b9\u6cd5\u7684\u5bf9\u6bd4<\/span><\/strong><\/p>\n

\u6b64\u5904\u7279\u522b\u9488\u5bf9HPLC\u4e0eTOC\u8fdb\u884c\u4e00\u4e0b\u8bb2\u89e3\uff1a<\/p>\n

\u4e00\u3001TOC\u4e0eHPLC\u6cd5\u7684\u6bd4\u8f83<\/p>\n

\u4e8c\u3001HPLC\u6cd5\u7684\u5c40\u9650\u6027<\/p>\n

\u4e09\u3001TOC\u66ff\u4ee3HPLC<\/p>\n

\u56db\u3001TOC\u6cd5\u7684\u4f18\u52bf<\/p>\n

\u4e94\u3001TOC\u6765\u68c0\u6d4b\u6cd5\u89c4\u4e0a\u7684\u652f\u6301<\/p>\n

 <\/p>\n

\u7b2c\u4e09\u7ae0TOC\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1<\/span><\/strong><\/p>\n

\u4e00\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u8981\u6c42<\/p>\n

\u4e8c\u3001TOC\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u524d\u63d0\uff1aTOC\u5206\u6790\u4eea\u7684\u6027\u80fd\u786e\u8ba4<\/p>\n

\u4e09\u3001\u7cfb\u7edf\u9002\u7528\u6027\u8bd5\u9a8c<\/p>\n

\u56db\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u8981\u70b9<\/p>\n

\u4e94\u3001TOC\u65b9\u6cd5\u9a8c\u8bc1\u7684\u5177\u4f53\u5185\u5bb9
<\/p>\n

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

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

\u27a4<\/span>\u4e13\u5c5e\u6027<\/p>\n

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

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

\u27a4<\/span>\u7ebf\u6027\u548c\u8303\u56f4<\/p>\n

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

\u27a4<\/span>\u7cbe\u5bc6\u5ea6\u548c\u51c6\u786e\u5ea6<\/p>\n

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

\u27a4<\/span>\u56de\u6536\u7387\u8bd5\u9a8c<\/p>\n

\u00d8  \u53d6\u6837\u65b9\u6cd5<\/p>\n

\u00d8  \u64e6\u62ed\u6cd5\u56de\u6536\u7387<\/p>\n

\u00d8  \u64e6\u62ed\u6280\u672f<\/p>\n

\u00d8  \u6dcb\u6d17\u6cd5\u56de\u6536\u7387<\/p>\n

\u00d8  \u56de\u6536\u7387\u63a5\u53d7\u7a0b\u5ea6<\/p>\n

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

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

\u27a4<\/span>\u6700\u4f4e\u68c0\u6d4b\u9650\uff08LOD\uff09\u3001\u6700\u4f4e\u5b9a\u91cf\u9650\uff08LOQ\uff09<\/p>\n

\u516d\u3001TOC\u5206\u6790\u65b9\u6cd5\u7684\u6ce8\u610f\u70b9<\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u7b2c\u4e00\u7ae0TOC\u57fa\u7840\u77e5\u8bc6<\/span><\/strong><\/span><\/p>\n

\u4e00\u3001\u4ec0\u4e48\u662f<\/span><\/strong>TOC<\/span><\/strong>\uff1f<\/span><\/strong><\/span><\/p>\n

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

TOC\u65b9\u6cd5\u68c0\u6d4b\u7684\u539f\u7406\uff1a<\/span><\/p>\n


<\/p>\n

\u603b\u6709\u673a\u78b3\uff08TOC\uff09\uff0c\u7531\u4e13\u95e8\u7684\u4eea\u5668\u2014\u2014\u603b\u6709\u673a\u78b3\u5206\u6790\u4eea\uff08\u4ee5\u4e0b\u7b80\u79f0TOC\u5206\u6790\u4eea\uff09\u6765\u6d4b\u5b9a\u3002TOC\u5206\u6790\u4eea\uff0c\u662f\u5c06\u6c34\u6eb6\u6db2\u4e2d\u7684\u603b\u6709\u673a\u78b3\u6c27\u5316\u4e3a\u4e8c\u6c27\u5316\u78b3\uff0c\u5e76\u4e14\u6d4b\u5b9a\u5176\u542b\u91cf\u3002\u5229\u7528\u4e8c\u6c27\u5316\u78b3\u4e0e\u603b\u6709\u673a\u78b3\u4e4b\u95f4\u78b3\u542b\u91cf\u7684\u5bf9\u5e94\u5173\u7cfb\uff0c\u4ece\u800c\u5bf9\u6c34\u6eb6\u6db2\u4e2d\u603b\u6709\u673a\u78b3\u8fdb\u884c\u5b9a\u91cf\u6d4b\u5b9a\u3002<\/span><\/p>\n


<\/p>\n

TOC\u6cd5\u5305\u62ec\u78b3\u7684\u6c27\u5316\u548c\u68c0\u6d4b\u751f\u6210\u7684\u4e8c\u6c27\u5316\u78b3\u4e24\u4e2a\u8fc7\u7a0b\u3002\u73b0\u6709\u591a\u79cd\u6c27\u5316\u6280\u672f\uff0c\u5305\u62ec\u5149\u89e6\u9176\u6c27\u5316\u3001\u5316\u5b66\u6c27\u5316\u53ca\u9ad8\u6e29\u707c\u70e7\u7b49\u3002<\/span><\/p>\n


<\/p>\n

\u4e8c\u3001\u4e3a\u4ec0\u4e48\u5728\u6e05\u6d01\u9a8c\u8bc1\u548c\u5e38\u89c4\u7684\u6e05\u6d01\u76d1\u6d4b\u4e2d\u4f7f\u7528TOC\uff1f<\/span><\/strong><\/span><\/p>\n

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

\u8bb8\u591a\u836f\u54c1\u5236\u9020\u573a\u6240\u76ee\u524d\u5df2\u7ecf\u4f7f\u7528TOC\u4f5c\u4e3aCV\u548c\u76d1\u6d4b<\/span><\/p>\n

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

\u27a4<\/span>\u975e\u4e13\u5c5e\u6027\u7684\u65b9\u6cd5\uff0c\u5728\u7406\u8bba\u4e0a\u80fd\u63a2\u6d4b\u5230\u6240\u6709\u542b\u6709\u6709\u673a\u78b3\u7684\u6b8b\u7559\u5206\u5b50\uff0c\u5bb9\u6613\u9a8c\u8bc1\u3002<\/span><\/p>\n

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

\u27a4<\/span>\u901a\u7528\u7684\u6837\u54c1\u5206\u6790\u65b9\u6cd5\uff1a\u6e05\u6d01\u9a8c\u8bc1\u548c\u786e\u8ba4\uff0c\u539f\u6750\u6599\u548c\u5de5\u5382\u7528\u6c34<\/span><\/p>\n

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

\u27a4<\/span>\u80fd\u5206\u6790\u5f88\u5927\u8303\u56f4\u7684\u6eb6\u89e3\uff0c\u201c\u4e0d\u6eb6\u201d\u53ca\u7edd\u5927\u90e8\u5206\u5236\u836f\u5382\u5de5\u4e1a\u4e2d\u7684\u5e38\u89c1\u5316\u5408\u7269<\/span><\/p>\n

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

\u27a4<\/span>TOC\u80fd\u63a2\u6d4b\u5230\u8bbe\u5907\u4e2d\u610f\u5916\u672a\u5b8c\u5168\u6e05\u6d01\u7684\u6709\u673a\u6742\u6280\u548c\u6b8b\u7559\u7269\u3002<\/span><\/p>\n

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

\u27a4<\/span>\u5f88\u9ad8\u5f88\u597d\u7684\u8d39\u7528\u8282\u7701\u3002\u7b80\u5355\u7684\u9a8c\u8bc1\u65b9\u6cd5\uff0c\u6613\u4e8e\u57f9\u8bad\u65b0\u4f7f\u7528\u8005\u3002<\/span><\/p>\n

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

\u27a4<\/span>\u63d0\u9ad8\u8bbe\u5907\u5468\u8f6c\u65f6\u95f4\u3002<\/span><\/p>\n


<\/p>\n

\u4e09\u3001\u6e05\u6d01\u9a8c\u8bc1\u4e2d\u7684TOC\u7684\u5e94\u7528<\/span><\/strong><\/span><\/p>\n

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

\u27a4<\/span>\u6d4b\u5b9a\u6e05\u6d01\u5242\u7684\u6b8b\u91cf<\/span><\/p>\n

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

\u27a4<\/span>\u4e0e\u7279\u5b9a\u5206\u6790\u76f8\u7ed3\u5408\u6765\u6d4b\u5b9a\u836f\u7684\u6210\u4efd<\/span><\/p>\n

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

\u27a4<\/span>\u4e3a\u5efa\u7acb\u6e05\u6d01\u7a0b\u5e8f\ufe50TOC\u88ab\u7528\u4f5c\u6e05\u6d01\u5ea6\u7684\u4e00\u822c\u6307\u793a<\/span><\/p>\n

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

\u27a4<\/span>\u6d4b\u5b9a\u6d3b\u6027\u6210\u4efd<\/span><\/p>\n

 <\/span><\/p>\n

\u56db\u3001\u4f55\u65f6\u53ef\u4f7f\u7528TOC\u6d4b\u5b9a<\/span><\/strong><\/span><\/p>\n

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

\u27a4<\/span>\u53d6\u51b3\u4e8e\u6b8b\u7559\u7269\u7684\u7c7b\u578b (\u6e05\u6d01\u5242\uff0c\u6d3b\u6027\u6210\u4efd\uff0c\u8d4b\u5f62\u5242)<\/span><\/p>\n

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

\u27a4<\/span>\u88ab\u6d4b\u7269\u662f\u5426\u662f\u6c34\u6eb6\u6027\u7684?<\/span><\/p>\n

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

\u27a4<\/span>\u88ab\u6d4b\u7269\u662f\u5426\u542b\u6709\u78b3?<\/span><\/p>\n

TOC\u975e\u4e13\u5c5e\u6027\u65b9\u6cd5\uff0cTOC\u6d4b\u5b9a\u7684\u662f\u975e\u786e\u5b9a\u7269<\/span><\/p>\n

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

\u27a4<\/span>TOC \u65b9\u6cd5\u53ef\u6d4b\u5b9a\u6837\u54c1\u4e2d\u7684\u6240\u6709\u6613\u6c27\u5316\u78b3\u542b\u91cf<\/span><\/p>\n

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

\u27a4<\/span>TOC \u65b9\u6cd5\u53ea\u9002\u7528\u4e8e\u6c34\u6eb6\u6db2\u6837\u54c1<\/span><\/p>\n

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

\u27a4<\/span>\u6d4b\u5b9a\u7ed3\u679c\u7684\u5355\u4f4d\u7528 ppb (ug\u78b3\/L) \u548c ppm (mg\u78b3\/L) \u6765\u8868\u793a<\/span><\/p>\n

 <\/span><\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n


<\/p>\n

Q\uff1a\u6b64\u5904\u5b58\u5728\u7591\u95ee\uff0c\u5982\u679c\u662f\u916f\u6eb6\u6027\u4ea7\u54c1\u80fd\u5426\u4f7f\u7528TOC\u6cd5\u8fdb\u884c\u6e05\u6d01\u9a8c\u8bc1\u7684\u68c0\u6d4b\uff1f<\/span><\/p>\n

A\uff1a\u901a\u8fc7\u67e5\u627e\u6587\u732e\u548c\u67e5\u9605\u76f8\u5173\u6750\u6599\uff0cTOC\u53ef\u4ee5\u68c0\u6d4b\u5230\u5728\u6c34\u4e2d\u6eb6\u89e3\u5ea6\u5f88\u4f4e\u7684\u6709\u673a\u7269\uff0c\u800c\u4e14\u51c6\u786e\u5ea6\u8fd8\u53ef\u4ee5\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4e94\u3001TOC\u6cd5\u4e0e\u5e38\u7528\u5206\u6790\u65b9\u6cd5\u7684\u6bd4\u8f83<\/span><\/strong><\/span><\/p>\n

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

\u27a4<\/span>TOC\u6cd5\u4e0eHPLC\u6cd5\u548cUV\/Vis\u5206\u5149\u5149\u5ea6\u6cd5\u4e0d\u540c\uff0c\u5c5e\u4e8e\u975e\u4e13\u5c5e\u6027\u65b9\u6cd5\uff0c\u662f\u68c0\u6d4b\u6240\u6709\u542b\u78b3\u5316\u5408\u7269\uff0c\u5305\u62ec\u6d3b\u6027\u7ec4\u5206\u3001\u8f85\u6599\u548c\u6e05\u6d01\u5242\u7684\u7406\u60f3\u65b9\u6cd5\u3002<\/span><\/p>\n

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

\u27a4<\/span>TOC\u6cd5\u7684\u7075\u654f\u5ea6\u53ef\u8fbe\u4ebf\u5206\u4e4b\u4e00\uff0c\u800c\u4e14\u4e0e HPLC\u6cd5\u548cUV\/Vis\u5206\u5149\u5149\u5ea6\u6cd5\u76f8\u6bd4\uff0e\u5177\u6709\u4e0d\u9700\u6478\u7d22\u6d3b\u6027\u6210\u5206\u7684\u68c0\u6d4b\u65b9\u6cd5\u548c\u8003\u8651\u6837\u54c1\u7684\u56e0\u7d20\uff0c\u8f83\u4e3a\u7701\u65f6\u7b49\u4f18\u70b9<\/span><\/p>\n\n\n\n\n\n\n\n\n\n
\n

\u65b9\u6cd5<\/span><\/strong><\/p>\n<\/td>\n

\n

\u4e13\u5c5e<\/span><\/strong><\/p>\n<\/td>\n

\n

\u836f\u6b8b\u91cf<\/span><\/strong><\/p>\n<\/td>\n

\n

\u8d4b\u5f62\u5242<\/span><\/strong><\/p>\n<\/td>\n

\n

\u6e05\u6d01\u5242<\/span><\/strong><\/p>\n<\/td>\n

\n

\u751f\u7269\u5236\u54c1<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\u662f<\/span><\/p>\n<\/td>\n

\n

\u662f<\/span><\/p>\n<\/td>\n

\n

\u662f<\/span><\/p>\n<\/td>\n

<\/td>\n\n

\u662f<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\u662f<\/span><\/p>\n<\/td>\n

\n

\u662f<\/span><\/p>\n<\/td>\n

\n

\u662f<\/span><\/p>\n<\/td>\n

<\/td>\n<\/td>\n<\/tr>\n
\n

TOC<\/strong><\/p>\n<\/td>\n

\n

\u5426<\/span><\/strong><\/p>\n<\/td>\n

\n

\u662f<\/span><\/strong><\/p>\n<\/td>\n

\n

\u662f<\/span><\/strong><\/p>\n<\/td>\n

\n

\u662f<\/span><\/strong><\/p>\n<\/td>\n

\n

\u662f<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\u662f<\/span><\/p>\n<\/td>\n

\n

\u662f<\/span><\/p>\n<\/td>\n

\n

\u662f<\/span><\/p>\n<\/td>\n

<\/td>\n\n

\u662f<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\u5426<\/span><\/p>\n<\/td>\n

<\/td>\n<\/td>\n\n

\u662f<\/span><\/p>\n<\/td>\n

<\/td>\n<\/tr>\n
\n

\u7535\u5bfc\u7387<\/span><\/p>\n<\/td>\n

\n

\u5426<\/span><\/p>\n<\/td>\n

<\/td>\n<\/td>\n\n

\u662f<\/span><\/p>\n<\/td>\n

<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Source: K.M.Jenkens, A.J. Vandervielen, Pharmaceutical Technology, April 1994<\/span><\/p>\n

TOC = \u6d3b\u6027\u7269 + \u8d4b\u5f62\u5242 + \u6e05\u6d01\u5242  + \u6c34\u7cfb\u7edf\u4e2d\u7684\u6709\u673a\u7269<\/span><\/p>\n


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

\u7b2c\u4e8c\u7ae0\u3000HPLC\u4e0eTOC\u65b9\u6cd5\u7684\u5bf9\u6bd4<\/span><\/strong><\/span><\/p>\n

\u6b64\u5904\u7279\u522b\u9488\u5bf9<\/span><\/strong>HPLC<\/strong>\u4e0e<\/span><\/strong>TOC<\/strong>\u8fdb\u884c\u4e00\u4e0b\u8bb2\u89e3\uff1a<\/span><\/strong><\/p>\n

\u4e00\u3001TOC\u4e0eHPLC\u6cd5\u7684\u6bd4\u8f83<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n\n\n\n\n
\n

HPLC<\/strong>\u65b9\u6cd5<\/span><\/strong><\/p>\n<\/td>\n

\n

TOC<\/strong>\u65b9\u6cd5<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

l<\/span>\u5bf9\u6bcf\u4e00\u79cd\u6709\u673a\u5316\u5408\u7269\u90fd\u6709\u7279\u522b\u9488\u5bf9\u6027<\/span><\/strong><\/p>\n

l<\/span>HPLC<\/strong>\u65b9\u6cd5\u9700\u8981\u6bcf\u4e00\u4e2a\u5355\u4e00\u7684\u5b9e\u9a8c\u8fc7\u7a0b<\/span><\/strong><\/p>\n

l<\/span>\u7075\u654f\u5ea6\uff08\u53d7\u5236\u4e8e\u68c0\u6d4b\u5668\u548c\u5316\u5408\u7269\uff09<\/span><\/strong><\/p>\n

l<\/span>\u53ef\u4ee5\u68c0\u6d4b\u4e0d\u6eb6\u4e8e\u6c34\u7684\u7269\u8d28<\/span><\/strong><\/p>\n

l<\/span>\u516c\u8ba4\u7684\u65b9\u6cd5\uff0c\u5e94\u7528\u5e7f\u6cdb<\/span><\/strong><\/p>\n

 <\/strong><\/p>\n<\/td>\n

\n

l<\/span>\u9488\u5bf9\u6027\u662f\u5bf9\u6240\u6709\u7684\u6709\u673a\u7269\uff0c\u56e0\u4e3a\u6240\u6709\u7684\u6709\u673a\u7269\u90fd\u88ab\u6c27\u5316<\/span><\/strong><\/p>\n

l<\/span>\u4e00\u4e2a<\/span><\/strong>TOC<\/strong>\u65b9\u6cd5\u5bf9\u4ed8\u6240\u6709\u7684\u5b9e\u9a8c\u8fc7\u7a0b\uff0c\u65e0\u9700\u8bbe\u7f6e\u5176\u4ed6\u53c2\u6570<\/span><\/strong><\/p>\n

l<\/span>\u7075\u654f\u5ea6\u9ad8\uff08<\/span><\/strong>1ppb C<\/strong>\uff09<\/span><\/strong><\/p>\n

l<\/span>\u5c11\u6570\u4e0d\u6eb6\u4e8e\u6c34\u7684\u6709\u673a\u5316\u5408\u7269\u4e5f\u80fd\u88ab\u68c0\u6d4b\u5230<\/span><\/strong><\/p>\n

l<\/span>\u5df2\u88ab\u5236\u9020\u4e1a\u7684\u6e05\u6d01\u9a8c\u8bc1\u6240\u63a5\u53d7<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/p>\n

\u4e8c\u3001HPLC\u6cd5\u7684\u5c40\u9650\u6027<\/span><\/strong><\/span>
<\/p>\n


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

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

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

\u91cd\u8981\u4e8b\u9879<\/span><\/p>\n

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

\u27a4<\/span>\u4e13\u5c5e\u6027\u5316\u5408\u7269\u5b9e\u9a8c<\/span><\/p>\n

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

\u27a4<\/span>\u4f7f\u7528\u6709\u673a\u6eb6\u5242<\/span><\/p>\n

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

\u27a4<\/span>\u57fa\u4e8e\u5316\u5408\u7269\u7684\u4e0b\u9650\u8ba1\u7b97<\/span><\/p>\n

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

\u27a4<\/span>\u6709\u9650\u7684\u5316\u5408\u7269\u6eb6\u51fa\u5ea6<\/span><\/p>\n

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

\u27a4<\/span>\u6709\u7528\u6700\u7ec8\u4ea7\u54c1\u7684\u653e\u884c<\/span><\/p>\n


<\/p>\n

\u81f4\u547d\u7684\u7f3a\u70b9<\/span><\/p>\n

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

\u27a4<\/span>HPLC\u7075\u654f\u5ea6\u7684\u5c40\u9650\u6027<\/span><\/p>\n

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

\u27a4<\/span>\u6bcf\u4e00\u4e2a\u9a8c\u8bc1\u90fd\u5fc5\u987b\u6709\u5355\u72ec\u7684SOP<\/span><\/p>\n

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

\u27a4<\/span>\u5f88\u957f\u7684\u542f\u52a8\u65f6\u95f4<\/span><\/p>\n

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

\u27a4<\/span>\u957f\u7684\u6837\u54c1\u5206\u6790\u65f6\u95f4<\/span><\/p>\n

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

\u27a4<\/span>\u5bf9CV\u6765\u8bf4\uff0c\u8bb8\u591a\u7684\u529f\u80fd\u4e0d\u9700\u8981<\/span><\/p>\n

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

\u27a4<\/span>\u8981\u5904\u7406\u65b0\u7684\u672a\u77e5\u5cf0<\/span><\/p>\n


<\/strong><\/p>\n

Example<\/strong>\uff1a<\/span><\/strong><\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n


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

\u5728\u6807\u51c6\u54c1\u51fa\u5cf0\u4f4d\u7f6e\u6ca1\u6709\u51fa\u5cf0\u3002<\/span><\/p>\n

\u901a\u8fc7\u6e05\u6d01\u9a8c\u8bc1\uff0c\u6ca1\u6709\u95ee\u9898\uff01<\/span><\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

1\u3001\u51fa\u5cf0\u4f4d\u7f6e\u5f02\u5e38\uff1b<\/span><\/p>\n

2\u3001\u51fa\u73b0\u5f02\u5e38\u672a\u77e5\u5cf0\uff1b<\/span><\/p>\n

\u4e0d\u80fd\u901a\u8fc7\u6e05\u6d01\u9a8c\u8bc1\uff0c\u540c\u65f6 FDA\u8981\u6c42\u786e\u8ba4\u672a\u77e5\u5cf0\uff01\u786e\u8ba4\u5de5\u4f5c\u7e41\u7410\u3002<\/span><\/p>\n


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

\u4e09\u3001TOC\u66ff\u4ee3HPLC<\/span><\/strong><\/span><\/p>\n

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

\u27a4<\/span>HPLC\u6bd4\u8f83\u96be\u4e8e\u4f7f\u7528\u4e14\u5fc5\u987b\u9a8c\u8bc1\u6bcf\u4e00\u4e2a\u6709\u673a\u5316\u5408\u7269<\/span><\/p>\n

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

\u27a4<\/span>\u65e0\u672a\u77e5HPLC\u5cf0\u65f6\u624d\u6ca1\u6709\u95ee\u9898<\/span><\/p>\n

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

\u27a4<\/span>TOC\u6613\u4e8e\u9a8c\u8bc1<\/span><\/p>\n

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

\u27a4<\/span>TOC\u53ef\u7528\u4e8e\u8bbe\u5907\u522e\u64e6\u540e\u6216\u7528\u4e8e\u6700\u7ec8\u7684\u6f02\u6d17\u6c34<\/span><\/p>\n

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

\u27a4<\/span>TOC\u57fa\u4e8e\u201c\u6700\u574f\u60c5\u5f62\u4e0b\u7684TOC\u4e0b\u9650\u201d<\/span><\/p>\n

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

\u27a4<\/span>\u7b49\u4e8e\u76ee\u6807\u5316\u5408\u7269\u7528\u78b3\u8ba1\u91cf\u7684\u4e0a\u9650\u6d53\u5ea6\uff08\u4e0d\u7b49\u4e8e\u5316\u5408\u7269\uff09<\/span><\/p>\n

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

\u27a4<\/span>\u6240\u6709\u6709\u673a\u6c61\u67d3\u7269\u7684\u603b\u548c\u5fc5\u987b\u5c0f\u4e8e\u4e0b\u9650<\/span><\/p>\n

 \uff08<\/span>\u6e05\u6d01\u9a8c\u8bc1\u4e2dHPLC\u5230TOC\u63a2\u6d4b\u7684\u8f6c\u5316\uff0c\u975e\u5e38\u5bb9\u6613\u505a\u5230\uff09<\/span><\/p>\n

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

\u27a4<\/span>\u8f6c\u6362HPLC\u4e0b\u9650\u4e2d\u5df2\u786e\u5b9a\u7684\u76ee\u6807\u5316\u5408\u7269\u6d53\u5ea6\u7684\u603b\u6709\u673a\u78b3\u7684\u603b\u548c\u3002<\/span><\/p>\n

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

\u27a4<\/span>\u5982\u679c\u5fc5\u987b\uff0c\u8c03\u6574\u6e05\u6d01\u7a0b\u5e8f\uff0c\u4ee5\u4fdd\u8bc1TOC\u4f4e\u4e8eTOC\u4e0b\u9650\u3002<\/span><\/p>\n


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

\u56db\u3001TOC\u6cd5\u7684\u4f18\u52bf<\/span><\/strong><\/span><\/p>\n

\u610f\u5473\u7740\u5c06\u6709\u673a\u7269\u4f5c\u4e3a\u4e13\u5c5e\u7269\u8d28\uff0c\u4e0d\u7ba1\u5176\u6765\u6e90\uff08\u5305\u62ec\u4ea7\u54c1\u3001\u6e05\u6d01\u5242\u3001\u5316\u5b66\u54c1\u3001\u6eb6\u5242\u3001\u526f\u4ea7\u7269\u53ca\u5fae\u751f\u7269\u6c61\u67d3\uff09\uff0c\u8981\u5224\u65ad\u51fa\u4efb\u4f55\u6b8b\u7559\u7269\u8d28\u662f\u5426\u5b58\u5728\uff0c\u91c7\u7528TOC\u5206\u6790\u80fd\u591f\u5730\u5f88\u597d\u5b8c\u6210\u8fd9\u4e00\u4efb\u52a1\uff0c\u53ea\u8981\u5176\u5206\u5b50\u7ed3\u6784\u4e2d\u5305\u542b\u78b3\uff0c\u5c31\u80fd\u591f\u68c0\u6d4b\u51fa\u4efb\u4f55\u7684\u6d3b\u6027\u5236\u836f\u6210\u5206\u6216\u8005\u6e05\u6d01\u7528\u7684\u6b8b\u7559\u7269\u8d28\u3002\u800c\u68c0\u6d4b\u7ed3\u679c\u5fc5\u987b\u4f4e\u4e8e\u76ee\u6807\u5316\u5408\u7269\u7269\u7684\u9650\u5ea6\uff0c\u63d0\u9ad8\u4e86\u6e05\u6d01\u9a8c\u8bc1\u7684\u4e25\u683c\u6027\u3002     <\/span><\/p>\n


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

\u4e94\u3001TOC\u6765\u68c0\u6d4b\u6cd5\u89c4\u4e0a\u7684\u652f\u6301<\/span><\/strong><\/span><\/p>\n

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

\u27a4<\/span> \u201c\u7136\u800c, \u4e0d\u50cf\u6700\u7ec8\u4ea7\u54c1\u7684\u6b8b\u7559\u7269, \u5728\u6e05\u6d17\u540e\u6211\u4eec\u671f\u671b\u65e0\u4efb\u4f55(\u6216\u5bf9\u975e\u5e38\u654f\u611f\u7684\u5206\u6790\u6765\u8bf4\u975e\u5e38\u4f4e)\u6e05\u6d01\u5242\u6b8b\u7559\u3002\u201d<\/span><\/p>\n

FDA Guide to Inspections of Validation of CleaningProcesses<\/span><\/p>\n

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

\u27a4<\/span>FDA\u5728\u68c0\u6d4b\u6c61\u67d3\u7269\u6b8b\u7559\u7684\u89c4\u7ae0\u6307\u5357\u4e2d\uff0c\u5df2\u7ecf\u63a5\u53d7\u4e86TOC\u65b9\u6cd5\u3002<\/span><\/p>\n

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

\u27a4<\/span>PDA\u6280\u672f\u62a5\u544a29\u53f7\u548c 49\u53f7\u7684\u9644\u5f55\u63d0\u5230\u5728\u65b0\u6e05\u6d01\u8fc7\u7a0b\u4e2d\u91c7\u7528 TOC \u65b9\u6cd5\u5e76\u53d6\u4ee3\u4e13\u5c5e\u6027\u65b9\u6cd5<\/span><\/p>\n

 <\/span><\/p>\n

\u672c\u6587\u4ef6\u91c7\u7528\u7684\u6700\u574f\u60c5\u51b5\u65b9\u6cd5\u4e13\u6ce8\u4e8e\u6e05\u6d01\u8fc7\u7a0b\u7ed3\u675f\u65f6\u53ef\u80fd\u5b58\u5728\u7684\u6b8b\u4f59\u7269\uff08\u6e05\u6d01\u5242\uff09\u3002\u4f46\u5e38\u89c1\u7684\u505a\u6cd5\u662f\u4f7f\u7528\u5de5\u827a\u4e2d\u7684\u6c61\u6e0d\uff0c\u6216\u7c7b\u4f3c\u836f\u54c1\u6216\u611f\u5174\u8da3\u7684\u5316\u5408\u7269\u7684\u66ff\u4ee3\u54c1\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5f3a\u70c8\u63a8\u8350\u5728\u6e05\u6d01\u9a8c\u8bc1\u4e2d\u91c7\u7528TOC\u5206\u6790\uff1a<\/span><\/p>\n

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

\u25c0<\/span>\u76f8\u5bf9\u8f83\u4f4e\u7684\u521d\u671f\u6295\u8d44\u4ee5\u53ca\u5f88\u4f4e\u7684\u64cd\u4f5c\u548c\u7ef4\u62a4\u7684\u8d39\u7528<\/span><\/p>\n

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

\u25c0<\/span>\u4f7f\u7528\u65b9\u4fbf\uff0c\u6613\u4e8e\u57f9\u8bad\u65b0\u4f7f\u7528\u8005<\/span><\/p>\n

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

\u25c0<\/span>\u6781\u9ad8\u7684\u7075\u654f\u5ea6\uff0c\u80fd\u591f\u6267\u884c\u4f4e\u6d53\u5ea6\u7684\u68c0\u6d4b\uff0c\u76f8\u6bd4\u4e8e\u5176\u5b83\u7684\u65b9\u6cd5\u6210\u672c\u6781\u4f4e\u5e76\u4e14\u80fd\u591f\u68c0\u6d4b\u6240\u6709\u542b\u78b3\u7c7b\u7684\u6b8b\u7559\u7269\u8d28<\/span><\/p>\n

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

\u25c0<\/span>\u5feb\u901f\u7684\u5206\u6790\u65f6\u95f4\u3002<\/span><\/p>\n

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

\u25c0<\/span>\u5e72\u6270\u6781\u5c0f<\/span><\/p>\n

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

\u25c0<\/span>\u63d0\u9ad8\u8bbe\u5907\u5468\u8f6c\u65f6\u95f4\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u7b2c\u4e09\u7ae0TOC\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1<\/span><\/strong><\/span><\/p>\n

\u4e00\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u8981\u6c42<\/span><\/strong><\/span><\/p>\n

\u5206\u6790\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u5305\u62ec\u7ebf\u6027\u3001\u68c0\u6d4b\u9650( MD )\u3001\u5b9a\u91cf\u9650 (COG)\u3001\u51c6\u786e\u5ea6\u3001\u7cbe\u786e\u5ea6\u4ee5\u53ca\u64e6\u62ed\u56de\u6536\u7387\u3002<\/span><\/p>\n

Refrence:USP<1226>and ICHQ2(R1)<\/span><\/p>\n

 <\/span><\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n


<\/p>\n

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

\u279c<\/span>\u53ea\u6709\u5728\u5206\u6790\u65b9\u6cd5\u662f\u53ef\u9760\u7684\u548c\u53ef\u91cd\u590d\u7684\u65f6\uff0c\u9a8c\u8bc1\u624d\u53ef\u901a\u8fc7\u3002<\/span><\/p>\n

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

\u279c<\/span>USP<1226>\u4e0eICH Q2\uff08R1\uff09\u9610\u8ff0\u4e86\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1\u7a0b\u5e8f\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4e8c\u3001TOC\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u524d\u63d0\uff1aTOC\u5206\u6790\u4eea\u7684\u6027\u80fd\u786e\u8ba4<\/span><\/strong><\/span><\/p>\n

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

\u27a4<\/span>\u5206\u6790\u4eea\u5668\u786e\u8ba4\u662f\u4e00\u4e2a\u8fc7\u7a0b\uff0c\u786e\u4fdd\u5bf9\u7279\u5b9a\u6d4b\u8bd5\u4f7f\u7528\u5206\u6790\u65b9\u6cd5\u662f\u80fd\u7b26\u5408\u76ee\u6807\u7528\u9014\u7684\u3002<\/span><\/p>\n

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

\u27a4<\/span>\u6839\u636ecGMP\u89c4\u5b9a\uff0c\u201c\u4f01\u4e1a\u6240\u4f7f\u7528\u7684\u68c0\u6d4b\u65b9\u6cd5\u7684\u51c6\u786e\u5ea6\u3001\u7075\u654f\u5ea6\uff08\u68c0\u6d4b\u9650\uff09\u3001\u4e13\u5c5e\u6027\u548c\u91cd\u73b0\u6027\uff08\u7cbe\u786e\u5ea6\uff09\u5fc5\u987b\u786e\u7acb\u5e76\u6709\u6587\u4ef6\u8bc1\u660e\u3002\u201d\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\u7528TOC\u6cd5\u8fdb\u884c\u6e05\u6d01\u8fc7\u7a0b\u9a8c\u8bc1\u7684\u6d4b\u8bd5\u4e4b\u524d\uff0c\u5bf9\u5206\u6790\u4eea\u5668\u8fdb\u884c\u4e25\u683c\u7684\u786e\u8ba4\u5c31\u5c24\u4e3a\u91cd\u8981\u3002\u6b64\u65b9\u6cd5\u5305\u62ec\u7531USP<1058>\u6240\u5efa\u8bae\u7684\u5b89\u88c5\u786e\u8ba4\u3001\u8fd0\u884c\u786e\u8ba4\u548c\u6027\u80fd\u786e\u8ba4\uff08IQ\/OQ\/PQ\uff09\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u300a\u4e2d\u56fd\u836f\u5178\u300b\uff082015\u7248\uff09\u56db\u90e8 <\/span>0682 <\/span>\u5236\u836f\u7528\u6c34\u4e2d\u603b\u6709\u673a\u78b3\u6d4b\u5b9a\u6cd5<\/span><\/p>\n

 <\/span><\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

\u4e09\u3001\u7cfb\u7edf\u9002\u7528\u6027\u8bd5\u9a8c<\/span><\/strong><\/span><\/p>\n

\u8981\u6c42\uff1a<\/span>\u54cd\u5e94\u6548\u7387\u5e94\u4e3a85\uff05\uff5e115\uff05\u3002<\/span><\/p>\n

\u8bd5\u5242\uff1a<\/span><\/p>\n

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

\u279c<\/span>\u8517\u7cd6\u6807\u51c6\u6eb6\u6db2\uff08\u542b\u78b3\u91cf0.500mg\/L\uff09<\/span><\/p>\n

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

\u279c<\/span>1\uff0c4-\u5bf9\u82ef\u918c\u6807\u51c6\u6eb6\u6db2\uff08\u542b\u78b3\u91cf0.500mg\/L\uff09<\/span><\/p>\n


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

\u56db\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u8981\u70b9<\/span><\/strong><\/span><\/p>\n

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

\u27a4<\/span>\u4e13\u5c5e\u6027\uff08%\u78b3\uff09<\/span><\/p>\n

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

\u27a4<\/span>\u7ebf\u6027\u5ea6\uff1a5\u70b9<\/span><\/p>\n

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

\u27a4<\/span>\u8303\u56f4\uff1a\u6700\u9ad8\u548c\u6700\u4f4e\u4e4b\u95f4\u7684\u6d53\u5ea6\u8986\u76d6\u57df<\/span><\/p>\n

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

\u27a4<\/span>\u51c6\u786e\u5ea6\uff1a\uff08\u603b\u6709\u673a\u78b3\uff09<\/span><\/p>\n

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

\u27a4<\/span>\u7cbe\u786e\u5ea6\uff1a%RSD\u767e\u5206\u6807\u51c6\u504f\u5dee<\/span><\/p>\n

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

\u27a4<\/span>\u6700\u4f4e\u68c0\u6d4b\u9650\uff08LOD\uff09\u3001\u6700\u4f4e\u5b9a\u91cf\u9650\uff08LOQ\uff09<\/span><\/p>\n

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

\u27a4<\/span>\u53ef\u9760\u6027\uff1a\u5728\u4e0d\u540c\u7684\u4f7f\u7528\u6761\u4ef6<\/span><\/p>\n


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

\u4e94\u3001TOC\u65b9\u6cd5\u9a8c\u8bc1\u7684\u5177\u4f53\u5185\u5bb9<\/span><\/strong><\/span><\/p>\n

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

\n
\n
\n
\n

\u27a4<\/span>\u4e13\u5c5e\u6027<\/p>\n


<\/p>\n

\u4e13\u5c5e\u6027\uff1a\u4e13\u5c5e\u6027\u662f\u80fd\u80fd\u975e\u5e38\u51c6\u786e\u5730\u786e\u5b9a\u6240\u5b58\u88ab\u6d4b\u7269\u8d28\u3002ICH Q2\uff08R1\uff09\u5982\u80fd\u5bf9\u76ee\u6807\u7269\u8d28\u8fdb\u884c\u51c6\u786e\u7684\u5b9a\u91cf\u68c0\u6d4b\uff0c\u6709\u673a\u78b3\uff0c\u5c31\u663e\u793a\u51fa\u8fd9\u5206\u6790\u65b9\u6cd5\u5bf9\u6709\u673a\u78b3\u5177\u6709\u4e13\u5c5e\u6027\u3002\u8fd9\u53ef\u901a\u8fc7\u68c0\u6d4b\u5177\u6709\u4ee3\u8868\u6027\u7684\u4e00\u4e9b\u6709\u673a\u2014\u2014\u53ef\u9009\u4e00\u4e9b\u542b\u6709\u9664\u78b3\u3001\u6c22\u3001\u6c27\u4ee5\u5916\u5143\u7d20\u7684\u6709\u673a\u7269\uff0c\u6bd4\u5982\u542b\u6709\u6c2f\u3001\u786b\u3001\u6c2e\u6216\u78f7\u7684\u6709\u673a\u7269<\/p>\n


<\/p>\n

Example\uff1aFDA\u7f3a\u9677\u4f8b\u5b50<\/p>\n


<\/p>\n

\u201cYour firm failed to establish and follow writtenprocedures to assure the cleaning and maintenance of equipment used in themanufacturing of drug products.  Forexample, cleaning validation for the CIP process vessel, which is utilized inthe aseptic formulation of the CIP process vessel, which is utilized in theaseptic formulation of trivalent bulk influenza vaccine\u2026 The study did notinclude swab sampling of the product transfer lines.\u201d<\/p>\n


<\/p>\n

\u8d35\u53f8\u672a\u80fd\u5efa\u7acb\u548c\u9075\u5faa\u5df2\u5199\u7684\u64cd\u4f5c\u89c4\u7a0b\uff0c\u5728\u836f\u54c1\u5236\u9020\u4e2d\u786e\u4fdd\u6e05\u6d01\u548c\u7ef4\u62a4\u8bbe\u5907\u3002\u4f8b\u5982\uff0c\u6d41\u611f\u75ab\u82d7\u7684CIP\u8fc7\u7a0b\u7f50\u6e05\u6d01\u9a8c\u8bc1\u672a\u5305\u62ec\u5bf9\u751f\u4ea7\u7ebf\u7684\u68c9\u7b7e\u53d6\u6837\u5b9e\u9a8c\u3002<\/p>\n


<\/p>\n

\u27a4<\/span>\u7ebf\u6027\u548c\u8303\u56f4<\/p>\n


<\/p>\n

\u7ebf\u6027\uff1a\u662f\u6307\u6d4b\u5b9a\u7ed3\u679c\u4e0e\u8bd5\u6837\u4e2d\u88ab\u6d4b\u7269\u6d53\u5ea6\u5448\u6b63\u6bd4\u5173\u7cfb\u7684\u7a0b\u5ea6\u3002<\/p>\n


<\/p>\n

\u8303\u56f4\uff1a\u662f\u6307\u80fd\u8fbe\u5230\u4e00\u5b9a\u7cbe\u5bc6\u5ea6\u3001\u51c6\u786e\u5ea6\u548c\u7ebf\u6027\uff0c\u6d4b\u8bd5\u65b9\u6cd5\u9002\u7528\u7684\u9ad8\u4f4e\u9650\u6d53\u5ea6\u6216\u91cf\u7684\u533a\u95f4\u3002<\/p>\n


<\/p>\n

\u279c<\/span>\u5b9a\u91cf\u68c0\u67e5\u5e94\u81f3\u5c11\u6d4b\u8bd55\u4e2a\u6d53\u5ea6\u8303\u56f4\u5e76\u4e14\u5305\u542b\u6e05\u6d01\u7684\u6700\u4f4e\u9650\u548c\u6700\u9ad8\u9650\u5ea6\u3002<\/p>\n

\u279c<\/span>\u7ebf\u6027\u7684\u76f8\u5173\u7cfb\u6570\u5e94\u4e0d\u4f4e\u4e8e0.98%\u3002<\/p>\n

\u279c<\/span>\u6d53\u5ea6\u8303\u56f4\u5e94\u8fbe\u5230\u6b8b\u7559\u7269\u9650\u5ea6\u768450%-150%\u3002<\/p>\n

\u279c<\/span>\u6dcb\u6d17\u6cd5\u548c\u68c9\u7b7e\u6cd5\u7528\u4e8e\u9650\u5ea6\u68c0\u67e5\u65f6\u4e0d\u9700\u505a\u7ebf\u6027\/\u8303\u56f4\u9a8c\u8bc1\u3002<\/p>\n


<\/p>\n

Example\uff1aTOC\u6d4b\u91cf\u503c\u548c\u76ee\u6807\u7269\u6d53\u5ea6\u7684\u76f8\u5173\u6027<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

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

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

\u53c2\u8003\u6587\u732e\uff1a\u300a\u836f\u7269\u5206\u6790\u6742\u5fd7\u300b 2013.33.\uff083\uff09<\/span><\/p>\n


<\/p>\n

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

\u27a4<\/span>\u7cbe\u5bc6\u5ea6\u548c\u51c6\u786e\u5ea6<\/span><\/p>\n

\u8981\u663e\u793aTOC\u6cd5\u7684\u7cbe\u5bc6\u5ea6\u548c\u51c6\u786e\u5ea6\uff0c\u4ee5\u542b10-6\u78b3\u7684\u6807\u51c6\u54c1\u6eb6\u6db2\u8fde\u7eed\u68c0\u6d4b10<\/span>\u6b21\u3002\u8fd9\u91cc\u9009\u7528\u6b64\u78b3\u6d53\u5ea6\u6765\u8bc4\u4f30\u7cbe\u5bc6\u5ea6\u548c\u51c6\u786e\u5ea6\u662f\u56e0\u4e3a\u901a\u5e38\u6b8b\u7559\u7269\u7684 TOC\u9650\u5ea6\u4e00\u822c\u4e3a\u6b64\u6c34\u5e73\u5de6\u53f3\u3002\u5728\u6b64 TOC\u6c34\u5e73\uff0c\u7cbe\u5bc6\u5ea6\u4e3a 1\uff05\uff0c\u51c6\u786e\u5ea6\u4e3a\u00b15\uff05\u3002<\/span><\/p>\n

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

\u27a4<\/span>\u56de\u6536\u7387\u8bd5\u9a8c<\/span><\/p>\n

\u786e\u5b9a\u5408\u9002\u53d6\u6837\u65b9\u6cd5\uff08\u51b2\u6d17\u65b9\u6cd5\u3001\u64e6\u62ed\u65b9\u6cd5\u3001\u53d6\u6837\u4eba\u5458\u7684\u64cd\u4f5c\u57f9\u8bad\u53ca\u68c0\u6d4b\u65b9\u6cd5\uff09\u53ef\u4f7f\u6c61\u67d3\u7269\/\u6b8b\u7559\u88ab\u6709\u6548\u6536\u56de\uff0c\u6700\u7ec8\u4e3a\u9a8c\u8bc1\u65b9\u6cd5\u63d0\u4f9b\u8bc1\u636e\u3002<\/span><\/p>\n

\u901a\u8fc7\u56de\u6536\u7387\u8bd5\u9a8c\u9a8c\u8bc1\u53d6\u6837\u8fc7\u7a0b\u7684\u56de\u6536\u7387\u548c\u91cd\u73b0\u6027\u3002<\/span><\/p>\n

\u901a\u5e38\u53d6\u6837\u56de\u6536\u7387\u548c\u68c0\u9a8c\u65b9\u6cd5\u56de\u6536\u7387\u7ed3\u5408\u8fdb\u884c\u3002<\/span><\/p>\n

\u00d8  \u53d6\u6837\u65b9\u6cd5<\/span><\/p>\n


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

\u65b9\u6cd5<\/span><\/strong><\/p>\n<\/td>\n

\n

\u64e6\u62ed\u6cd5<\/span><\/strong><\/p>\n<\/td>\n

\n

\u6dcb\u6d17\u6cd5<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\u5b9a\u4e49<\/span><\/strong><\/p>\n<\/td>\n

\n

\u5728\u63a2\u9488\u7684\u4e00\u7aef\u88c5\u4e0a\u4e00\u79cd\u60f0\u6027\u6750\u6599\uff08\u901a\u5e38\u7528\u539f\u68c9\u6216\u7c7b\u4f3c\u7684\u6750\u6599\uff09\uff0c\u7528\u5b83\u7cfb\u7edf\u7684\u4ea4\u53c9\u6469\u64e6\u8868\u9762\u3002<\/span><\/p>\n<\/td>\n

\n

\u53d6\u6dcb\u6d17\u7ebf\u8def\u7684\u6700\u4e0b\u6e38\u7684\u6392\u6c34\u53e3\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4f18\u70b9<\/span><\/strong><\/p>\n<\/td>\n

\n

\u00d8  <\/span><\/span>\u53ef\u4ee5\u8bc4\u4f30\u96be\u4ee5\u6e05\u6d17\u548c\u76f8\u5f53\u5bb9\u6613\u63a5\u8fd1\u7684\u533a\u57df\uff0c\u4f7f\u5f97\u53ef\u786e\u5b9a\u6bcf\u4e2a\u7ed9\u51fa\u7684\u8868\u9762\u533a\u57df\u7684\u6c61\u67d3\u7269\u6216\u6b8b\u7559\u7269\u7684\u7ea7\u522b\u3002<\/span><\/p>\n

\u00d8  <\/span><\/span>\u4e0d\u80fd\u6eb6\u89e3\u7684\u6b8b\u7559\u7269\u53ef\u4ee5\u901a\u8fc7\u7269\u7406\u5207\u9664\u7684\u65b9\u6cd5\u6765\u53d6\u6837\u3002<\/span><\/p>\n<\/td>\n

\n

\u00d8  <\/span><\/span>\u5927\u9762\u79ef\u7684\u53d6\u6837\u3002<\/span><\/p>\n

\u00d8  <\/span><\/span>\u53ef\u4ee5\u5bf9\u4eba\u4e3a\u8fbe\u4e0d\u5230\u6216\u5e38\u89c4\u4e0d\u80fd\u5378\u89e3\u7684\u7cfb\u7edf\u8fdb\u884c\u53d6\u6837\u548c\u8bc4\u4f30\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7f3a\u70b9<\/span><\/strong><\/p>\n<\/td>\n

\n

\u00d8  <\/span><\/span>\u4e0d\u6613\u5728\u5927\u578b\u8bbe\u5907\u4e0a\u5b9e\u65bd\u3002<\/span><\/p>\n

\u00d8  <\/span><\/span>\u4ece\u5c0f\u9762\u79ef\u83b7\u5f97\u7684\u7ed3\u679c\u5916\u63a8\u81f3\u8bbe\u5907\u7684\u6574\u4e2a\u4ea7\u54c1\u63a5\u89e6\u8868\u9762\u3002<\/span><\/p>\n

\u00d8  <\/span><\/span>\u4e0d\u6613\u5bf9\u96be\u63a5\u8fd1\u7684\u533a\u57df\u8fdb\u884c\u53d6\u6837\u3002<\/span><\/p>\n<\/td>\n

\n

\u00d8  <\/span><\/span>\u6b8b\u7559\u7269\u6216\u6c61\u67d3\u7269\u53ef\u80fd\u4e0d\u6eb6\u89e3\u6216\u5835\u585e\u5728\u8bbe\u5907\u4e2d\u3002<\/span><\/p>\n

\u00d8  <\/span><\/span>\u53d7\u88ab\u53d6\u6837\u7269\u6eb6\u89e3\u6027\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

\u00d8  <\/span><\/span>\u53ea\u662f\u7b80\u5355\u68c0\u6d4b\u51b2\u6d17\u6c34\u7684\u8d28\u91cf\uff08\u5b83\u662f\u5426\u7b26\u5408\u6d4b\u8bd5\u7eb2\u8981\uff09\u800c\u4e0d\u68c0\u6d4b\u6f5c\u5728\u7684\u6c61\u67d3\u7269\u7684\u505a\u6cd5\u662f\u4e0d\u88ab\u8ba4\u53ef\u7684\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u00d8  \u64e6\u62ed\u6cd5\u56de\u6536\u7387<\/span><\/p>\n

\u53ef\u63a5\u53d7\u6807\u51c6    \u56de\u6536\u7387\uff1a\u226550%<\/span><\/p>\n

              \u91cd\u73b0\u6027\uff1a\u226420%<\/span><\/p>\n

\u6b65\u9aa4\u4e3e\u4f8b\uff1a<\/span><\/p>\n

1\u3001\u51c6\u59071\u5757500 mm \u00d7500 mm\u7684\u5e73\u6574\u5149\u6d01\u7684\u4e0d\u9508\u94a2\u677f\u3002<\/span><\/p>\n

2\u3001\u5728\u94a2\u677f\u4e0a\u7528\u94a2\u9525\u5212\u51fa400 mm \u00d7400 mm\u7684\u533a\u57df\u6bcf\u9694100 mm\u5212\u7ebf\u5f62\u621016\u5757100 mm \u00d7100mm\u7684\u65b9\u5757\u3002<\/span><\/p>\n

3\u3001\u914d\u5236\u6d53\u5ea6\u4e3a160 mg\/L\u7684\u59a5\u5e03\u9709\u7d20\u6c34\u6eb6\u6db2\u5b9a\u91cf\u88c5\u5165\u55b7\u96fe\u5668\u3002<\/span><\/p>\n

4\u3001\u5c06\u7ea610 mL\u6eb6\u6db2\u5c3d\u91cf\u5747\u5300\u5730\u55b7\u5728400 mm \u00d7400 mm\u7684\u533a\u57df\u5185\u3002<\/span><\/p>\n

5\u3001\u6839\u636e\u5b9e\u9645\u55b7\u51fa\u7684\u6eb6\u6db2\u91cf\u8ba1\u7b97\u5355\u4f4d\u9762\u79ef\u4e0a\u7684\u59a5\u5e03\u9709\u7d20\u91cf\u7ea61\u03bcg\/100mm2\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

 <\/span><\/p>\n\n\n\n\n\n\n
\n

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

<\/td>\n\n

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

<\/td>\n<\/tr>\n
<\/td>\n\n

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

<\/td>\n\n

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

\n

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

<\/td>\n\n

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

<\/td>\n<\/tr>\n
<\/td>\n\n

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

<\/td>\n\n

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

6\u3001\u81ea\u7136\u5e72\u71e5\u6216\u7528\u7535\u5439\u98ce\u6e29\u548c\u5730\u5439\u5e72\u4e0d\u9508\u94a2\u677f\u3002<\/span><\/p>\n

7\u3001\u7528\u6ce8\u5c04\u7528\u6c34\u6da6\u6e7f\u68c9\u7b7e\u6309\u64e6\u62ed\u53d6\u6837\u64cd\u4f5c\u89c4\u7a0b\u64e6\u62ed\u94a2\u677f\u6bcf\u64e6\u4e00\u4e2a\u65b9\u5757\uff0c100 cm2\u6362\u4e00\u6839\u68c9\u7b7e\u3002\u5728\u94a2\u677f\u4e0a\u53d6\u5747\u5e03\u76848\u4e2a\u65b9\u5757\u3002<\/span><\/p>\n

8\u3001\u5c06\u68c9\u7b7e\u5206\u522b\u653e\u5165\u8bd5\u7ba1\u4e2d\u5b9a\u91cf\u52a0\u5165\u6ce8\u5c04\u7528\u6c3410 mL\uff0c\u52a0\u585e\u8f7b\u6447\u8bd5\u7ba1\u5e76\u653e\u7f6e10 min\uff0c\u4f7f\u7269\u8d28\u6eb6\u51fa\u3002\u7136\u540e\u5c06\u6eb6\u6db2\u7a00\u91ca10\u500d\u3002<\/span><\/p>\n

9\u3001\u4f7f\u7528TOC\u5206\u6790\u4eea\u6d4b\u5b9a\u6b64\u6e05\u6d01\u9a8c\u8bc1\u6c34\u6837\u7684TOC\u503c\u3002<\/span><\/p>\n


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

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

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

10\u3001\u8ba1\u7b97\u56de\u6536\u7387\u3002<\/span><\/p>\n

\u64e6\u62ed\u56de\u6536\u7387\uff08%\uff09=0.8914\/1\u00d7100%=89.1%<\/span><\/p>\n

         <\/span><\/strong>\u5e26\u5165\u6821\u6b63\u516c\u5f0f                           \u5b9e\u9645\u8ba1\u7b97\u503c<\/span><\/p>\n

\"\u8d70\u8fd1\u6e05\u6d01\u9a8c\u8bc1\u65b0\u65b9\u6cd5\u2014\u2014TOC\u6cd5\"<\/p>\n

\u7ed3\u8bba\uff1a\u7406\u60f3\u7684\u56de\u6536\u7387\uff0c\u8bf4\u660eTOC\u5206\u6790\u65b9\u6cd5\u9002\u5408\u76ee\u6807\u5316\u5408\u7269\u64e6\u62ed\u6cd5\u7684\u6e05\u6d01\u9a8c\u8bc1\u68c0\u6d4b\u3002<\/span><\/p>\n

 <\/strong><\/p>\n

\u00d8  \u64e6\u62ed\u6280\u672f<\/span><\/p>\n

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

 <\/span><\/p>\n


<\/p>\n

\u6ce8\u610f\uff1a\u8fde\u8d2f\u6027\uff0c\u56fa\u5b9a\u7684\u529b\u5ea6\u3001\u901f\u5ea6\u548c\u7ebf\u8def\u3002<\/span><\/p>\n


<\/p>\n

\u00d8  \u6dcb\u6d17\u6cd5\u56de\u6536\u7387<\/span><\/p>\n

\u901a\u5e38\u6dcb\u6d17\u6cd5\u9650\u5ea6\u68c0\u67e5\u4e0d\u9700\u505a\u56de\u6536\u7387\u9a8c\u8bc1\uff0c\u5b9a\u91cf\u68c0\u67e5\u5e94\u505a\u56de\u6536\u7387\u9a8c\u8bc1\u3002<\/span>\u53ef\u4ee5\u5229\u7528\u6dcb\u6d17\u6eb6\u5242\u51b2\u6d17\u5df2\u77e5\u91cf\uff08\u5728\u9650\u5ea6\u9644\u8fd1\uff09\u7684\u5206\u6790\u7269\u786e\u5b9a\u56de\u6536\u7387\uff0c\u56de\u6536\u7387\u901a\u5e38\u5e94\u4e0d\u4f4e\u4e8e95%\u3002<\/span><\/p>\n


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

\u6dcb\u6d17\u6cd5\u6837\u54c1\u53ef\u5bf9\u51b2\u6d17\u6db2\u76f4\u63a5\u68c0\u6d4b\uff0c\u4e5f\u53ef\u5bf9\u51b2\u6d17\u6db2\u505a\u7a00\u91ca\u540e\u68c0\u6d4b\uff0c\u65e0\u8bba\u76f4\u63a5\u68c0\u6d4b\u8fd8\u662f\u7a00\u91ca\u68c0\u6d4b\u90fd\u5e94\u5728\u63a5\u5230\u6837\u54c1\u540e\u9996\u5148\u5c06\u6837\u54c1\u540c\u7a7a\u767d\u6eb6\u5242\u505a\u89c6\u89c9\u68c0\u67e5\u786e\u5b9a\u662f\u5426\u6709\u989c\u8272\u5dee\u5f02\u548c\u5f02\u7269\u5b58\u5728\uff0c\u5982\u679c\u6709\u8ff0\u73b0\u8c61\u53d1\u751f\uff0c\u53ef\u76f4\u63a5\u5224\u5b9a\u6837\u54c1\u4e0d\u5408\u683c\u3002<\/span><\/p>\n


<\/p>\n

\u00d8  \u56de\u6536\u7387\u63a5\u53d7\u7a0b\u5ea6<\/span><\/p>\n

 <\/span><\/p>\n\n\n\n\n\n\n
\n

\u6d4b\u8bd5\u7ed3\u679c<\/span><\/strong><\/p>\n<\/td>\n

\n

\u8bc4\u4ef7<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\uff1e80%<\/span><\/strong><\/p>\n<\/td>\n

\n

1. <\/span><\/span><\/strong>\u53ef\u63a5\u53d7<\/span><\/strong><\/p>\n

2. <\/span><\/span><\/strong>\u826f\u597d\u7684\u6837\u54c1\u91c7\u96c6\u65b9\u6cd5<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\uff1e50%<\/span><\/strong><\/p>\n<\/td>\n

\n

1. <\/span><\/span><\/strong>\u7406\u8bba\u4e0a\u53ef\u63a5\u53d7<\/span><\/strong><\/p>\n

2. <\/span><\/span><\/strong>\u9700\u8981\u8bc4\u4ef7\u662f\u5426\u53ef\u4ee5\u63d0\u9ad8<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\uff1c50%<\/span><\/strong><\/p>\n<\/td>\n

\n

1. <\/span><\/span><\/strong>\u4e0d\u5408\u683c<\/span><\/strong><\/p>\n

2. <\/span><\/span><\/strong>\u800c\u4e14\u9700\u8981\u8c03\u67e5<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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

\u27a4<\/span>\u6700\u4f4e\u68c0\u6d4b\u9650\uff08LOD\uff09\u3001\u6700\u4f4e\u5b9a\u91cf\u9650\uff08LOQ\uff09<\/span><\/p>\n


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

LOD\/LOQ\u63a8\u6f14\u6cd5<\/span><\/strong><\/p>\n

\u8bb0\u5f55\u4f4e\u6d53\u5ea6\u7eaf\u5c5e\u6807\u6837\u7684\u5b9e\u6d4bTOC\u503c\u548c\u6807\u51c6\u504f\u5dee\uff08\u7528250\u3001500\u3001750ppbTOC\u7684\u8517\u7cd6\uff09<\/span><\/p>\n

\u4f7f\u7528\u6700\u5c0f\u4e8c\u4e58\u7ebf\u6027\u56de\u5f52\u7b97\u6cd5\uff0c\u786e\u5b9a\u6807\u6837\u7684\u6807\u51c6\u5dee\u6bd4\u5b9e\u6d4b\u6d53\u5ea6\u7684\u65b9\u7a0b\uff1b\u786e\u5b9aY\u8f74\u4e3a\u6807\u51c6\u504f\u5dee\uff0cX\u8f74\u4e3a\u6df1\u5ea6\u3002<\/span><\/p>\n

\u6839\u636e\u56de\u5f52\u5206\u6790\u786e\u5b9a\u8be5\u884c\u7684Y\u8f74\u622a\u8ddd<\/span><\/p>\n

Y\u8f74\u622a\u8ddd\u4ee3\u8868\u96f6\u5206\u6790\u7269\u6d53\u5ea6\u65f6\u7684\u6807\u51c6\u4f2a\u5584\uff08Y\u8f74\u622a\u8ddd\uff1d\u2502S0\u2502\uff09<\/span><\/p>\n

\u8ba1\u7b97\u68c0\u6d4b\u9650\uff08LOD\uff1d\u2502Y\u8f74\u622a\u8ddd\u2502\u00d73\uff09<\/span><\/p>\n

\u8ba1\u7b97\u68c0\u6d4b\u9650\uff08LOQ\uff1d\u2502Y\u8f74\u622a\u8ddd\u2502\u00d710\uff09<\/span><\/p>\n


<\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span>Taylor,John K,Quality Assurance of Chemical Measurement(\u5316\u5b66\u6d4b\u91cf\u7684\u8d28\u91cf\u4fdd\u8bc1)  Lewis Publishers imprint of CRC press(1987)<\/span><\/p>\n


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

\u516d\u3001TOC\u5206\u6790\u65b9\u6cd5\u7684\u6ce8\u610f\u70b9<\/span><\/strong><\/span><\/p>\n

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

\n
\n
\n
\n

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

\u279c<\/span>\u6700\u597d\u4f7f\u7528\u6821\u51c6\u66f2\u7ebf\uff0c\u5373TOC\u548c\u76ee\u6807\u7269\u6d53\u5ea6\u7684\u7ebf\u6027\u76f8\u5173\u6027\u662f\u5426\u826f\u597d\u3002\u56e0\u4e3a\u6bcf\u4e00\u6709\u673a\u7269\u7684\u6c27\u5316\u6548\u7387\u662f\u4e0d\u540c\u7684\u3002\uff08\u9664\u975e\u6c27\u5316\u6548\u7387\u9ad8\uff0c\u53ef\u4ee5\u5ffd\u7565\uff09<\/span><\/p>\n


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

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

\u279c<\/span>\u64e6\u62ed\u6cd5\u9700\u8981\u540c\u65f6\u5bf9\u7167\u6eb6\u5242\uff08\u5982\u6ce8\u5c04\u7528\u6c34\uff09\u548c\u7a7a\u767d\u68c9\u7b7e\uff0c\u5373\u64e6\u62ed\u7a7a\u767dcoupons\uff0c\u8fdb\u884cTOC\u5206\u6790\uff0c\u6765\u5224\u5b9a\u5e72\u6270\u7a0b\u5ea6\u3002<\/span><\/p>\n


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

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

\u279c<\/span>\u5fc5\u987b\u9009\u62e9\u539f\u7406\u3001\u91cf\u7a0b\u5408\u9002\u7684TOC\u5206\u6790\u4eea\u3002\u56e0\u4e3a\u6e05\u6d01\u9a8c\u8bc1\u7684\u6c34\u6837\u4e0e\u6ce8\u5c04\u7528\u6c34\u4e0d\u540c\uff0c\u65e0\u6cd5\u9884\u6d4b\u6c34\u6837\u7684\u6e05\u6d01\u7a0b\u5ea6\u3002
<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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