{"id":1427,"date":"2018-06-23T01:00:00","date_gmt":"2018-07-27T06:28:26","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/cde%ef%bc%9a%e5%85%b3%e4%ba%8e%e5%8f%91%e5%b8%83%e3%80%8a%e5%8c%96%e5%ad%a6%e4%bb%bf%e5%88%b6%e8%8d%af%e6%b3%a8%e5%86%8c%e6%89%b9%e7%94%9f%e4%ba%a7%e8%a7%84%e6%a8%a1%e7%9a%84%e4%b8%80%e8%88%ac\/"},"modified":"2018-07-27T14:28:27","modified_gmt":"2018-07-27T06:28:27","slug":"cde%ef%bc%9a%e5%85%b3%e4%ba%8e%e5%8f%91%e5%b8%83%e3%80%8a%e5%8c%96%e5%ad%a6%e4%bb%bf%e5%88%b6%e8%8d%af%e6%b3%a8%e5%86%8c%e6%89%b9%e7%94%9f%e4%ba%a7%e8%a7%84%e6%a8%a1%e7%9a%84%e4%b8%80%e8%88%ac","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/1427\/","title":{"rendered":"CDE\uff1a\u5173\u4e8e\u53d1\u5e03\u300a\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\uff08\u8bd5\u884c\uff09\u300b\u7684\u901a\u77e5"},"content":{"rendered":"
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3.\u7279\u6b8a\u6ce8\u5c04\u5242\uff08\u5982\u8102\u8d28\u4f53\u3001\u5fae\u7403\u3001\u80f6\u675f\u7b49\uff09\/\u5438\u5165\u6c14\u96fe\u5242\/\u5438\u5165\u7c89\u96fe\u5242\uff1a\u5efa\u8bae\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u4e0e\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u4e00\u81f4\u3002<\/span><\/p>\n

4.\u900f\u76ae\u8d34\u5242\uff1a\u6ce8\u518c\u6279\u4e09\u6279\u5747\u5e94\u81f3\u5c11\u8fbe\u5230\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u768410%\uff08\u5305\u88c5\u540e\uff09\uff0c\u6216\u800525,000\u4e2a\u5236\u5242\u5355\u4f4d\uff08\u6bcf\u79cd\u89c4\u683c\uff09\uff0c\u4e24\u8005\u4e2d\u9009\u66f4\u591a\u7684\u3002\u5bf9\u4e8e\u9aa8\u67b6\u578b\u4ea7\u54c1\uff0c\u4ee5\u900f\u76ae\u8d34\u7247\u5927\u5c0f\uff08\u8868\u9762\u79ef\uff09\u6765\u786e\u5b9a\u4e0d\u540c\u89c4\u683c\u65f6\uff0c\u5efa\u8bae\u7533\u62a5\u65f6\u63d0\u4ea4\u91c7\u7528\u4e09\u6279\u9aa8\u67b6\u5c42\u751f\u4ea7\u7684\u8d34\u7247\u7814\u7a76\u6570\u636e\u3002<\/span><\/p>\n

5.\u4e73\u818f\u5242\/\u8f6f\u818f\u5242\/\u51dd\u80f6\u5242\/\u6813\u5242\uff1a\u5bf9\u4e8e\u975e\u65e0\u83cc\u5236\u5242\uff0c\u6ce8\u518c\u6279\u4e09\u6279\u5747\u5e94\u81f3\u5c11\u8fbe\u5230100kg\u6216\u8005\u62df\u5b9a\u5546\u4e1a\u5316\u751f\u4ea7\u89c4\u6a21\u768410%\uff0c\u4e24\u8005\u4e2d\u9009\u66f4\u591a\u7684\uff08\u5305\u88c5\u540e\uff09\u3002<\/span><\/p>\n

6.\u5176\u4ed6\uff1a\u5bf9\u4e8e\u672c\u6587\u672a\u6d89\u53ca\u7684\u5176\u4ed6\u5236\u5242\u7c7b\u578b\uff0c\u5176\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u53ef\u53c2\u7167\u76f8\u5173\u56fd\u9645\u901a\u884c\u6280\u672f\u6307\u5357\u6267\u884c\u3002\u5bf9\u4e8e\u4ee5\u4e0b\u60c5\u51b5\uff0c\u5176\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u53ef\u4f4e\u4e8e\u4e0a\u8ff0\u8981\u6c42\uff1a\uff081\uff09\u7ecf\u56fd\u5bb6\u76f8\u5173\u90e8\u95e8\u786e\u5b9a\u4e3a\u7528\u4e8e\u7f55\u89c1\u75c5\u6cbb\u7597\u7684\u836f\u7269\u5236\u5242\uff1b\uff082\uff09\u6309\u56fd\u5bb6\u89c4\u5b9a\u8fdb\u884c\u7ba1\u5236\u7684\u836f\u7269\u5236\u5242\u3002<\/span><\/p>\n

\u5982\u6709\u5176\u5b83\u7279\u6b8a\u539f\u56e0\uff08\u5546\u4e1a\u56e0\u7d20\u9664\u5916\uff09\u65e0\u6cd5\u6ee1\u8db3\u4e0a\u8ff0\u57fa\u672c\u8981\u6c42\u7684\uff0c\u5efa\u8bae\u7533\u62a5\u524d\u4e0e\u76d1\u7ba1\u673a\u6784\u8fdb\u884c\u6c9f\u901a\u3002<\/span> <\/span><\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n

1.ICH Q1A(R2): Stability Testing of New Drug Substances andProducts. February, 2003.<\/span><\/p>\n

2.<\/span>\u5316\u5b66\u836f\u7269\uff08\u539f\u6599\u836f\u548c\u5236\u5242\uff09\u7a33\u5b9a\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u4fee\u8ba2\uff09\u3002<\/span><\/p>\n

3.<\/span>\u4e2d\u56fd\u836f\u5178\uff08<\/span>2015<\/span>\u5e74\u7248\u56db\u90e8\u6307\u5bfc\u539f\u5219<\/span>9011<\/span>\uff09\uff1a\u836f\u7269\u5236\u5242\u4eba\u4f53\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u3002<\/span><\/p>\n

4. FDA (May 2014), Guidance for Industry ANDAs StabilityTesting of Drug Substances and Products Questions and Answers.<\/span><\/p>\n

5.WHO Technical Report Series, No. 953, 2009. Annex 2 Stabilitytesting of active pharmaceutical ingredients and finished pharmaceuticalproducts.<\/span><\/p>\n

6.<\/span>\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40<\/span>. <\/span>\u5173\u4e8e\u53d1\u5e03\u5316\u5b66\u836f\u54c1\u65b0\u6ce8\u518c\u5206\u7c7b\u7533\u62a5\u8d44\u6599\u8981\u6c42\uff08\u8bd5\u884c\uff09\u7684\u901a\u544a\uff08<\/span>2016<\/span>\u5e74\u7b2c<\/span>80<\/span>\u53f7\uff09\u3002<\/span><\/p>\n


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\u6765\u6e90\uff1aCDE<\/span><\/p>\n

\u836f\u7814\u7f16\u8f91\u6574\u7406<\/span><\/p>\n

\n


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\u58f0\u660e\uff1a\u836f\u7814\u5bf9\u672c\u6587\u9648\u8ff0\u548c\u89c2\u70b9\u4fdd\u6301\u4e2d\u7acb\uff0c\u4e0d\u5bf9\u6587\u7ae0\u5185\u5bb9\u53ef\u9760\u6027\u63d0\u4f9b\u4efb\u4f55\u4fdd\u8bc1\u3002\u4ec5\u4f9b\u53c2\u8003\uff01\u672c\u6587\u4ec5\u4e3a\u5b66\u4e60\u4ea4\u6d41\uff0c\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\uff0c\u5982\u9047\u7248\u6743\u95ee\u9898\u8bf7\u8054\u7cfb\u6211\u4eec\u5220\u9664\uff0c\u8c22\u8c22\uff01<\/span><\/p>\n


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\u5173\u6ce8\u836f\u7814  \u4e00\u8def\u540c\u884c<\/span><\/p>\n

\u57f9\u8bad\uff5c\u6295\u7a3f\uff5c\u5408\u4f5c<\/span><\/p>\n

V:<\/span>diaodiao666666<\/span><\/p>\n<\/section>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u7814 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u9644\u4ef6\uff1a  \u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\uff08\u8bd5\u884c\uff09  \u4e3a\u8fdb\u4e00\u6b65\u8d2f\u5f7b\u4e2d\u5171\u4e2d\u592e\u529e\u516c\u5385\u3001\u56fd\u52a1 […]<\/p>\n","protected":false},"author":1,"featured_media":1428,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/1427"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=1427"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/1427\/revisions"}],"predecessor-version":[{"id":1432,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/1427\/revisions\/1432"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/1428"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=1427"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=1427"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=1427"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}