{"id":42832,"date":"2020-04-21T10:58:41","date_gmt":"2020-04-21T08:58:41","guid":{"rendered":"https:\/\/kymos.com\/news\/%e4%ba%9a%e7%a1%9d%e8%83%ba%e7%ad%9b%e6%9f%a5%ef%bc%9a%e4%bb%8a%e6%97%a5%e6%89%a9%e5%a4%a7%e8%8c%83%e5%9b%b4%ef%bc%8c%e6%98%8e%e6%97%a5%e9%99%8d%e4%bd%8e%e6%88%90%e6%9c%ac\/"},"modified":"2026-07-07T12:57:44","modified_gmt":"2026-07-07T10:57:44","slug":"%e4%ba%9a%e7%a1%9d%e8%83%ba%e7%ad%9b%e6%9f%a5%ef%bc%9a%e4%bb%8a%e6%97%a5%e6%89%a9%e5%a4%a7%e8%8c%83%e5%9b%b4%ef%bc%8c%e6%98%8e%e6%97%a5%e9%99%8d%e4%bd%8e%e6%88%90%e6%9c%ac","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e4%ba%9a%e7%a1%9d%e8%83%ba%e7%ad%9b%e6%9f%a5%ef%bc%9a%e4%bb%8a%e6%97%a5%e6%89%a9%e5%a4%a7%e8%8c%83%e5%9b%b4%ef%bc%8c%e6%98%8e%e6%97%a5%e9%99%8d%e4%bd%8e%e6%88%90%e6%9c%ac\/","title":{"rendered":"\u4e9a\u785d\u80fa\u7b5b\u67e5\uff1a\u4eca\u65e5\u6269\u5927\u8303\u56f4\uff0c\u660e\u65e5\u964d\u4f4e\u6210\u672c"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-text-transform:none;\"><h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 17; line-height: 1.67; --minfontsize: 17;\" data-fontsize=\"17\" data-lineheight=\"28.39px\"><span style=\"font-size: 14pt;\"><strong>\u7b80\u4ecb<\/strong><\/span><\/h3>\n<div class=\"blog-content\">\n<div class=\"field field-name-body field-type-text-with-summary field-label-hidden\">\n<div class=\"field-items\">\n<div class=\"field-item even\">\n<p><span style=\"font-size: 14pt;\">\u6211\u4eec\u7684\u8d28\u91cf\u63a7\u5236\u7ecf\u7406\u517c Pharmaprogress \u8054\u5408\u521b\u59cb\u4eba Luca Gramaccioni \u535a\u58eb\u5728\u8d28\u8c31\u5206\u6790\u9886\u57df\u62e5\u6709\u8fd1\u4e8c\u5341\u5e74\u7684\u7ecf\u9a8c\u3002\u5728\u8fd9\u91cc\uff0c\u4ed6\u5c06\u8c08\u8bba\u6700\u65b0\u7684\u4e9a\u785d\u80fa\u622a\u6b62\u65e5\u671f\u5ef6\u671f\u4ee5\u53ca\u6211\u4eec\u9886\u5148\u7684\u7b5b\u67e5\u670d\u52a1\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u76d1\u7ba1\u673a\u6784\u6700\u8fd1\u5c06\u4e9a\u785d\u80fa\u98ce\u9669\u8bc4\u4f30\u7684\u622a\u6b62\u65e5\u671f\u5ef6\u957f\u81f3 2020 \u5e74 10 \u6708 1 \u65e5\uff0c\u8fd9\u4e3a\u6211\u4eec\u7684\u5ba2\u6237\u63d0\u4f9b\u4e86\u989d\u5916\u7684\u65f6\u95f4\u6765\u8fdb\u884c\u66f4\u591a\u7684\u521d\u6b65\u7b5b\u67e5\uff0c\u5e76\u6700\u5927\u9650\u5ea6\u5730\u964d\u4f4e\u98ce\u9669\u8bc4\u4f30\u540e\u4e9a\u785d\u80fa\u5b9a\u91cf\u8981\u6c42\u7684\u6210\u672c\u3002\u6211\u4eec\u7684 Kymos \u548c Pharmaprogress \u56e2\u961f\u4e0d\u65ad\u52aa\u529b\u4f7f\u6211\u4eec\u5f00\u521b\u6027\u7684\u4e9a\u785d\u80fa\u670d\u52a1\u9002\u5e94\u65b0\u7684\u8981\u6c42\uff0c\u56e0\u6b64\uff0c\u6211\u4eec\u4e24\u79cd\u53ef\u9009\u7684 HS-GC\/MS \u548c LC-MS\/MS \u5206\u6790\u65b9\u6cd5\u4ee5\u53ca\u5305\u542b 15 \u79cd\u4e9a\u785d\u80fa\u7684\u9a8c\u8bc1\u5217\u8868\u73b0\u5728\u5f97\u5230\u4e86\u589e\u5f3a\uff0c\u4e3a\u90a3\u4e9b\u5bfb\u6c42\u4ece\u5176\u4ea7\u54c1\u3001\u8f85\u6599\u6216\u539f\u6750\u6599\u4e2d\u83b7\u53d6\u989d\u5916\u6570\u636e\u4ee5\u8fdb\u884c\u66f4\u7a33\u5065\u7684\u98ce\u9669\u8bc4\u4f30\u5e76\u907f\u514d\u989d\u5916\u5b9a\u91cf\u6b65\u9aa4\u7684\u516c\u53f8\u63d0\u4f9b\u66f4\u5feb\u3001\u66f4\u7075\u6d3b\u4e14\u66f4\u5177\u6210\u672c\u6548\u76ca\u7684\u975e GMP \u4e9a\u785d\u80fa\u7b5b\u67e5\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u5728\u4ee5\u4e0b\u60c5\u51b5\u4e0b\uff0c\u5feb\u901f\u4e9a\u785d\u80fa\u7b5b\u67e5\u53ef\u4ee5\u5e26\u6765\u8bb8\u591a\u4f18\u52bf\uff1a<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u98ce\u9669\u5206\u6790\u4e0d\u5b8c\u6574\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u4f9b\u5e94\u5546\u6ca1\u6709\u63d0\u4f9b\u8d35\u516c\u53f8\u9700\u8981\u7684\u6240\u6709\u7b54\u6848\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u516c\u53f8\u9700\u8981\u52a0\u5f3a\u98ce\u9669\u8bc4\u4f30\u7684\u7ed3\u679c\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u5229\u7528\u989d\u5916\u7684 6 \u4e2a\u6708\u65f6\u95f4\u6765\u51c6\u5907\u6587\u4ef6\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u57fa\u4e8e HS-GC\/MS \u7684\u5feb\u901f\u7b5b\u67e5\u662f\u5feb\u901f\u5206\u6790\u539f\u6750\u6599\u4ee5\u6df1\u5165\u8c03\u67e5\u5176\u4e9a\u785d\u80fa\u542b\u91cf\u7684\u826f\u597d\u673a\u4f1a\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u6211\u4eec HS-GC\/MS \u65b9\u6cd5\u7684\u4f18\u52bf<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u9ad8\u7075\u654f\u5ea6\uff08\u4ee5\u4e0b\u662f 0.03 ppm \u8c31\u56fe\u7684\u4e24\u79cd\u9009\u62e9\uff09\u3002<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u540c\u65f6\u6d4b\u5b9a 10 \u79cd\u6700\u6613\u6325\u53d1\u7684\u4e9a\u785d\u80fa\uff0c\u5305\u62ec EMA | FDA \u548c USP &lt;381&gt;\uff08\u6ce8\u5c04\u7528\u5305\u88c5\/\u7ed9\u836f\u7cfb\u7edf\u5f39\u6027\u4f53\u4e2d\u7684\u4e9a\u785d\u80fa\u6742\u8d28\u5316\u5408\u7269\uff09\u4e2d\u63d0\u5230\u7684\u4e9a\u785d\u80fa\u3002<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u9876\u7a7a\u81ea\u52a8\u8fdb\u6837\u53ef\u4ee5\u907f\u514d\u4efb\u4f55\u4e0e\u539f\u6750\u6599\u6eb6\u89e3\u76f8\u5173\u7684\u6311\u6218\u3002\u8fd9\u610f\u5473\u7740\u53ef\u4ee5\u5728\u77ed\u65f6\u95f4\u5185\u5904\u7406\u4e0d\u540c\u7684\u6750\u6599\u5e76\u5f97\u51fa\u7ed3\u679c\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u5728 1 ppb \u65f6\u5177\u6709\u975e\u5e38\u7a33\u5065\u4e14\u53ef\u91cd\u73b0\u7684\u68c0\u51fa\u9650 (LOD)\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\"><strong>\u6211\u4eec LC-MS\/MS \u65b9\u6cd5\u7684\u4f18\u52bf<\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5e26\u6709 APCI \u79bb\u5b50\u6e90\u7684 LC-MS\/MS \u65b9\u6cd5\u53ef\u7528\u4e8e\u4ee5\u4e0b\u573a\u666f\u548c\u60c5\u51b5\uff1a<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u540c\u65f6\u6d4b\u5b9a\u6325\u53d1\u6027\u548c\u975e\u6325\u53d1\u6027\u4e9a\u785d\u80fa<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"> \u4e09\u91cd\u56db\u6781\u6746\u4fdd\u8bc1\u7684\u9009\u62e9\u6027\u5e26\u6765\u7684\u9ad8\u7075\u654f\u5ea6<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u901a\u8fc7\u4e0d\u540c\u7684\u6761\u4ef6\u5b9a\u5236\u65b9\u6cd5\uff0c\u4ece\u800c\u5bf9\u611f\u5174\u8da3\u7684\u4e9a\u785d\u80fa\u548c\u4ea7\u54c1\u7684\u5176\u4ed6\u6210\u5206\u5b9e\u73b0\u4e0d\u540c\u7684\u9009\u62e9\u6027<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">C18 \u56fa\u5b9a\u76f8<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">CN \u56fa\u5b9a\u76f8<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">PFP \u56fa\u5b9a\u76f8<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u82ef\u57fa\u5df1\u57fa\u56fa\u5b9a\u76f8\uff08\u4ee5\u4e0b\u4e3a 0.03 ppm \u5904\u7684\u8c31\u56fe\uff09<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u5176\u4ed6\u4e9a\u785d\u80fa\u7684\u8c31\u56fe\uff1a<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">EMA \u5ef6\u957f\u4e86\u5b8c\u6210\u5236\u9020\u5de5\u827a\u5ba1\u67e5\u7b2c 1 \u6b65\u7684<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/referral-procedures-human-medicines\/nitrosamine-impurities\" target=\"_blank\" rel=\"noopener\" data-wpel-link=\"external\">\u622a\u6b62\u65e5\u671f<\/a>\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u70b9\u51fb\u4e86\u89e3\u66f4\u591a\u5173\u4e8e\u6211\u4eec\u7684<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\/\" data-wpel-link=\"internal\">\u4e9a\u785d\u80fa\u7b5b\u67e5\u80fd\u529b<\/a>\uff0c\u6216\u901a\u8fc7 <a href=\"mailto:commercial@kymos.com?subject=New%20instruments%20at%20Kymos\" data-wpel-link=\"internal\">commercial<\/a><a href=\"mailto:info@kymos.com\" data-wpel-link=\"internal\">@kymos.com<\/a> \u8054\u7cfb\u6211\u4eec\u3002<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":42833,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[381],"tags":[],"class_list":["post-42832","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u4e9a\u785d\u80fa\u7b5b\u67e5 | Kymos \u96c6\u56e2<\/title>\n<meta name=\"description\" content=\"\u4e86\u89e3\u6700\u65b0\u7684\u4e9a\u785d\u80fa\u622a\u6b62\u65e5\u671f\u5ef6\u671f\uff0c\u5e76\u7531 Luca Gramaccioni \u535a\u58eb\u4e3a\u60a8\u4ecb\u7ecd\u6211\u4eec\u9886\u5148\u7684\u7b5b\u67e5\u670d\u52a1\u3002\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kymos.com\/zh-hans\/news\/%e4%ba%9a%e7%a1%9d%e8%83%ba%e7%ad%9b%e6%9f%a5%ef%bc%9a%e4%bb%8a%e6%97%a5%e6%89%a9%e5%a4%a7%e8%8c%83%e5%9b%b4%ef%bc%8c%e6%98%8e%e6%97%a5%e9%99%8d%e4%bd%8e%e6%88%90%e6%9c%ac\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u4e9a\u785d\u80fa\u7b5b\u67e5 | Kymos \u96c6\u56e2\" \/>\n<meta property=\"og:description\" content=\"\u4e86\u89e3\u6700\u65b0\u7684\u4e9a\u785d\u80fa\u622a\u6b62\u65e5\u671f\u5ef6\u671f\uff0c\u5e76\u7531 Luca Gramaccioni \u535a\u58eb\u4e3a\u60a8\u4ecb\u7ecd\u6211\u4eec\u9886\u5148\u7684\u7b5b\u67e5\u670d\u52a1\u3002\" \/>\n<meta property=\"og:url\" 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