{"id":42977,"date":"2024-01-23T08:46:04","date_gmt":"2024-01-23T07:46:04","guid":{"rendered":"https:\/\/kymos.com\/news\/%e6%9d%82%e8%b4%a8%e8%b0%b1%e5%88%86%e6%9e%90%ef%bc%9a%e8%8d%af%e7%89%a9%e4%b8%ad%e6%9c%aa%e7%9f%a5%e6%9d%82%e8%b4%a8%e7%9a%84%e8%a1%a8%e5%be%81\/"},"modified":"2024-01-23T08:46:04","modified_gmt":"2024-01-23T07:46:04","slug":"%e6%9d%82%e8%b4%a8%e8%b0%b1%e5%88%86%e6%9e%90%ef%bc%9a%e8%8d%af%e7%89%a9%e4%b8%ad%e6%9c%aa%e7%9f%a5%e6%9d%82%e8%b4%a8%e7%9a%84%e8%a1%a8%e5%be%81","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e6%9d%82%e8%b4%a8%e8%b0%b1%e5%88%86%e6%9e%90%ef%bc%9a%e8%8d%af%e7%89%a9%e4%b8%ad%e6%9c%aa%e7%9f%a5%e6%9d%82%e8%b4%a8%e7%9a%84%e8%a1%a8%e5%be%81\/","title":{"rendered":"\u6742\u8d28\u8c31\u5206\u6790\uff1a\u836f\u7269\u4e2d\u672a\u77e5\u6742\u8d28\u7684\u8868\u5f81"},"content":{"rendered":"<p><span style=\"font-size: 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style=\"font-size: 14pt;\">\u5728\u5236\u9020\u8fc7\u7a0b\u4e2d\u53d1\u73b0\u6216\u5728\u50a8\u5b58\u671f\u95f4\u4ea7\u751f\u3002\u5b83\u4eec\u53ef\u4ee5\u662f\u5df2\u9274\u5b9a\u7684\u6216\u672a\u9274\u5b9a\u7684\u3002\u5305\u62ec\u8d77\u59cb\u539f\u6599\u3001\u526f\u4ea7\u7269\u3001\u4e2d\u95f4\u4f53\u3001\u964d\u89e3\u4ea7\u7269\u3001\u8bd5\u5242\u3001\u914d\u4f53\u548c\u50ac\u5316\u5242\u3002  <\/span><\/li>\n<li>\n<h3><span style=\"font-size: 14pt;\"><strong>\u65e0\u673a\u6742\u8d28\uff1a <\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\u4ea7\u751f\u4e8e\u5236\u9020\u8fc7\u7a0b\uff0c\u901a\u5e38\u662f\u5df2\u77e5\u4e14\u5df2\u9274\u5b9a\u7684\u3002\u5305\u62ec\u8bd5\u5242\u3001\u914d\u4f53\u3001\u50ac\u5316\u5242\u3001<a href=\"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e5%85%83%e7%b4%a0%e3%80%81%e4%ba%9a%e7%a1%9d%e8%83%ba%e5%8f%8a%e5%85%b6%e4%bb%96%e6%9d%82%e8%b4%a8\/%e5%85%83%e7%b4%a0%e6%9d%82%e8%b4%a8\/\" data-wpel-link=\"internal\">\u91cd\u91d1\u5c5e\u6216\u5176\u4ed6\u6b8b\u7559\u91d1\u5c5e<\/a>\u3001\u65e0\u673a\u76d0\u4ee5\u53ca\u52a9\u6ee4\u5242\u6216\u6d3b\u6027\u70ad\u7b49\u5176\u4ed6\u6750\u6599\u3002 <\/span><\/li>\n<li>\n<h3><span style=\"font-size: 14pt;\"><strong>\u6b8b\u7559\u6eb6\u5242\uff1a <\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">\u6e90\u81ea\u5236\u9020\u8fc7\u7a0b\uff0c\u5e76\u6839\u636e\u5bf9\u4eba\u7c7b\u6216\u52a8\u7269\u5065\u5eb7\u7684\u6f5c\u5728\u98ce\u9669\u8fdb\u884c\u5206\u7c7b\u3002\u9605\u8bfb\u66f4\u591a\u5173\u4e8e <a href=\"https:\/\/kymos.com\/zh-hans\/news\/vich-gl18-r2%ef%bc%9a%e5%85%bd%e8%8d%af%e4%ba%a7%e5%93%81%e6%ae%8b%e7%95%99%e6%ba%b6%e5%89%82%e7%9a%84%e5%8f%98%e5%8c%96\/\" data-wpel-link=\"internal\">VICH GL18 (R2) \u548c\u6b8b\u7559\u6eb6\u5242<\/a>\u7684\u4fe1\u606f\u3002 <\/span><\/li>\n<\/ul>\n<h2><strong>\u6742\u8d28\u63a7\u5236\u53ca\u5176\u8868\u5f81\u6307\u5357<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u5982\u524d\u6240\u8ff0\uff0cICH \u6307\u5357\u8981\u6c42\uff0c\u65b0\u836f\u7269\u7269\u8d28\u4e2d\u5b58\u5728\u7684\u4efb\u4f55\u542b\u91cf\u9ad8\u4e8e 0.1% \u7684\u672a\u77e5\u6742\u8d28\u90fd\u5fc5\u987b\u8fdb\u884c\u8868\u5f81\u3002\u5982\u679c\u8d85\u8fc7\u6b64\u9608\u503c\uff0c\u5219\u9700\u8981\u5bf9\u5176\u8fdb\u884c\u9274\u5b9a\u5e76\u5728\u8d28\u91cf\u6807\u51c6\u4e2d\u5355\u72ec\u5217\u51fa\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u76f8\u53cd\uff0c\u5982\u679c\u6742\u8d28\u4f4e\u4e8e\u6b64\u9650\u5ea6\uff0c\u901a\u5e38\u4e0d\u9700\u8981\u8fdb\u884c\u9274\u5b9a\uff0c\u9664\u975e\u9884\u8ba1\u5176\u6f5c\u5728\u5371\u5bb3\u5f02\u5e38\u9ad8\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0cICH \u6307\u5357\u8981\u6c42\uff0c\u5982\u679c\u5728\u836f\u7269\u4ea7\u54c1\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u4e2d\u68c0\u6d4b\u5230\u7684\u964d\u89e3\u4ea7\u7269\u542b\u91cf\u9ad8\u4e8e\u9274\u5b9a\u9608\u503c\uff0c\u4e5f\u5fc5\u987b\u5bf9\u5176\u8fdb\u884c\u9274\u5b9a\u3002\u8fd9\u4e9b\u9650\u5ea6\u53ef\u5728 <a href=\"https:\/\/www.ema.europa.eu\/en\/ich-q3a-r2-impurities-new-drug-substances-scientific-guideline\" data-wpel-link=\"external\">ICH Q3A (R2)<\/a> \u4e2d\u627e\u5230\u3002 <\/span><\/p>\n<h2><strong>\u7528\u4e8e\u6742\u8d28\u8c31\u5206\u6790\u7684\u6280\u672f<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u5728\u9274\u5b9a\u6742\u8d28\u548c\u964d\u89e3\u4ea7\u7269\u65f6\uff0c\u53ef\u4ee5\u91c7\u7528\u591a\u79cd\u65b9\u6cd5\u3002\u4f20\u7edf\u65b9\u6cd5\u6d89\u53ca\u4f7f\u7528\u5df2\u5f00\u53d1\u7684\u65b9\u6cd5\uff08\u901a\u5e38\u901a\u8fc7\u52a0\u6807\u6cd5\uff09\uff0c\u5bf9\u7167\u6807\u51c6\u54c1\u9a8c\u8bc1\u672a\u77e5\u5206\u6790\u7269\u7684\u4fdd\u7559\u65f6\u95f4\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5f53\u5cf0\u503c\u9ad8\u4e8e\u9274\u5b9a\u9608\u503c\u65f6\uff0c\u4f1a\u5c06\u5176\u6807\u8bb0\u4ee5\u8fdb\u884c\u9274\u5b9a\u548c\u7ed3\u6784\u9610\u660e\u3002\u5728 Kymos \u96c6\u56e2\uff0c\u8fd9\u4e00\u8fc7\u7a0b\u901a\u5e38\u4f7f\u7528 <strong>UPLC \u6216 HPLC<\/strong> \u6267\u884c\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5c3d\u7ba1\u591a\u5e74\u6765\u8fd9\u4e00\u76f4\u662f\u4f20\u7edf\u65b9\u6cd5\uff0c\u4f46\u6211\u4eec\u4e3b\u8981\u4f7f\u7528<strong>\u8054\u7528\u6280\u672f\uff0c\u56e0\u4e3a\u5f53\u9700\u8981\u5728\u5355\u4e2a\u6837\u54c1\u4e2d\u8868\u5f81\u591a\u79cd\u6742\u8d28\u65f6\uff0c\u8054\u7528\u6280\u672f\u66f4\u5feb\u4e14\u66f4\u6613\u4e8e\u4f7f\u7528\u3002<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5b83\u4eec\u4e5f\u66f4\u53d7\u9752\u7750\uff0c\u56e0\u4e3a<strong>\u6211\u4eec\u907f\u514d\u4e86\u5f62\u6210\u4e0d\u7a33\u5b9a\u6742\u8d28\u65f6\u53ef\u80fd\u51fa\u73b0\u7684\u95ee\u9898<\/strong>\uff0c\u6216\u8005\u5904\u7406\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u53d1\u751f\u4e8c\u6b21\u53cd\u5e94\u7684\u60c5\u51b5\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u51fa\u4e8e\u8fd9\u4e9b\u7279\u5b9a\u539f\u56e0\uff0c\u6211\u4eec\u51b3\u5b9a\u4f7f\u7528 <strong>LC-MS<\/strong>\uff0c\u56e0\u4e3a\u5b83\u6709\u6f5c\u529b\u63d0\u4f9b\u5173\u4e8e\u672a\u77e5\u5206\u6790\u7269\u7684\u8fd1\u4e4e\u6e05\u6670\u7684\u7ed3\u6784\u4fe1\u606f\uff0c\u7279\u522b\u662f Orbitrap \u9ad8\u5206\u8fa8\u8d28\u8c31\u4eea\u3002 <\/span><\/p>\n<h2><strong>Kymos \u96c6\u56e2\u7684\u4ea7\u80fd\u4e0e\u65b0\u8bbe\u65bd<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u4e3a\u5e94\u5bf9 2023 \u5e74\u4e1a\u52a1\u7684\u6301\u7eed\u589e\u957f\uff0c\u7279\u522b\u662f\u4e3a\u4e86\u6ee1\u8db3\u5ba2\u6237\u5728\u6742\u8d28\u5206\u6790\u548c\u6d4b\u8bd5\u65b9\u9762\u7684\u9700\u6c42\uff0c\u6211\u4eec\u6700\u8fd1\u6269\u5efa\u4e86\u4f4d\u4e8e\u610f\u5927\u5229\u7684\u573a\u5730\uff0c\u914d\u5907\u4e86\u5168\u65b0\u7684\u8bbe\u65bd\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u5ea7\u65b0\u5efa\u7b51\u7684\u9762\u79ef\u662f\u4e4b\u524d\u5de5\u5382\u7684\u4e09\u500d\uff0c\u62e5\u6709\u4e09\u4e2a\u91c7\u7528<a href=\"https:\/\/kymos.com\/news\/u-shape-lean-lab-improving-productivity-in-laboratory\/\" data-wpel-link=\"external\">\u201c\u7cbe\u76ca\u5b9e\u9a8c\u5ba4\u65b9\u6cd5\u201d<\/a>\u8bbe\u8ba1\u7684\u65b0\u5b9e\u9a8c\u5ba4\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u9879\u6218\u7565\u6295\u8d44\u4e0d\u4ec5\u5c06\u5927\u5e45\u63d0\u9ad8\u6211\u4eec\u7684\u6742\u8d28\u5206\u6790\u80fd\u529b\uff0c\u8fd8\u5c06\u6269\u5927\u6211\u4eec\u5728\u751f\u7269\u5236\u836f\u4ea7\u54c1\u7684\u7814\u7a76\u3001\u5f00\u53d1\u548c\u8d28\u91cf\u63a7\u5236\u65b9\u9762\u7684\u670d\u52a1\u8303\u56f4\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u65b0\u5b9e\u9a8c\u5ba4\u5728\u5bf9\u8bbe\u65bd\u8fdb\u884c\u5f7b\u5e95\u7684\u5b9e\u5730\u5ba1\u8ba1\u540e\uff0c\u5df2\u83b7\u5f97 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