{"id":101257,"date":"2025-04-22T10:41:20","date_gmt":"2025-04-22T02:41:20","guid":{"rendered":"http:\/\/www.broadbio.com\/?p=101257"},"modified":"2025-04-22T10:41:27","modified_gmt":"2025-04-22T02:41:27","slug":"%e7%be%8e%e5%9b%bd%e8%8d%af%e5%85%b8usp","status":"publish","type":"post","link":"http:\/\/www.broadbio.com\/archives\/101257","title":{"rendered":"\u7f8e\u56fd\u836f\u5178USP"},"content":{"rendered":"\n

\u7f8e\u56fd\u836f\u5178USP<\/strong><\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

\u300a\u7f8e\u56fd\u836f\u5178\/\u56fd\u5bb6\u5904\u65b9\u96c6\u300b\uff08U.S. Pharmacopoeia \/ National Formulary\uff0c\u7b80\u79f0 USP\uff09\u662f\u7f8e\u56fd\u836f\u54c1\u8d28\u91cf\u63a7\u5236\u7684\u6743\u5a01\u6307\u5bfc\u6587\u732e\uff0c\u7531 \u7f8e \u56fd \u836f \u5178 \u59d4 \u5458 \u4f1a \uff08 The United States Pharmacopeial Convention\uff09\u8d1f\u8d23\u7f16\u8f91\u548c\u51fa\u7248\uff0c\u6536\u5f55\u4e86\u5c1a\u672a\u88ab\u7f8e\u56fd\u836f\u5178\u6b63\u5f0f\u7eb3\u5165\u7684\u65b0\u836f\u548c\u65b0\u5236\u5242\uff0c\u5e76\u5206\u4e3a\u4e09\u5377\u3002\u7b2c\u4e00\u5377\u5305\u542b\u524d\u8a00\u3001\u51e1\u4f8b\u3001\u901a\u5219\u8bd5\u5242\u3001\u5404\u8bba\u3001\u53c2\u8003\u56fe\u8868\u3001\u98df\u54c1\u8865\u5145\u5242\u4ee5\u53ca\u68c0\u7d22\u7b49\uff1b\u800c\u7b2c\u4e8c\u5377\u548c\u7b2c\u4e09\u5377\u4e3b\u8981\u6db5\u76d6\u4e86 USP \u7684\u51e1\u4f8b\u548c\u5404\u8bba\u5185\u5bb9\u3002<\/p>\n\n\n\n

\u7f8e\u56fd\u836f\u5178USP\u6807\u51c6\u54c1\uff1a\u7f8e\u56fd\u836f\u5178\u59d4\u5458\u4f1a (USP) \u662f\u4e00\u5bb6\u975e\u8425\u5229\u6027\u79d1\u7814\u673a\u6784\uff0c\u4e3a\u5168\u4e16\u754c\u751f\u4ea7\u3001\u7ecf\u9500\u3001\u4f7f\u7528\u7684\u836f\u54c1\u3001\u98df\u54c1\u6210\u5206\u548c\u81b3\u98df\u8865\u5145\u5242\u7684\u8d28\u91cf\u3001\u7eaf\u5ea6\u3001\u9274\u5b9a\u548c\u6d53\u5ea6\u8bbe\u7acb\u6807\u51c6\u3002USP-NF\u7684\u6807\u51c6\u5728\u7f8e\u56fd\u7531\u836f\u54c1\u4e0e\u98df\u54c1\u7ba1\u7406\u5c40 (FDA) \u5f3a\u5236\u5b9e\u65bd\uff0c\u5168\u4e16\u754c\u6709140\u591a\u4e2a\u56fd\u5bb6\/\u5730\u533a\u4e5f\u5728\u5236\u5b9a\u548c\u91c7\u7528\u8fd9\u4e9b\u6807\u51c6\u3002USP\u6807\u51c6\u7269\u8d28\u662f\u7279\u6027\u6781\u5f3a\u7684\u7269\u7406\u6837\u672c\uff0c\u88ab\u5236\u836f\u53ca\u76f8\u5173\u884c\u4e1a\u7528\u6765\u8fdb\u884c\u5404\u79cd\u6d4b\u8bd5\uff0c\u4ee5\u5e2e\u52a9\u9a8c\u8bc1\u836f\u54c1\uff08\u836f\u54c1\u3001\u751f\u7269\u5236\u5242\u548c\u8f85\u6599\uff09\u3001\u98df\u7269\u8865\u5145\u5242\u548c\u98df\u54c1\u6210\u5206\u7684\u7279\u6027\u3001\u6548\u529b\u3001\u8d28\u91cf\u548c\u7eaf\u5ea6\u3002<\/p>\n\n\n\n

USP\u5927\u4e2d\u534e\u533a\u603b\u90e8\u901a\u8fc7\u4e86ISO9001:2008\u8ba4\u8bc1\uff0c\u5171\u4eab\u7f8e\u56fd\u836f\u5178\u5168\u7403\u8ba4\u8bc1\u8bc1\u4e66<\/p>\n\n\n\n

USP\u5927\u4e2d\u534e\u533a\u603b\u90e8\u901a\u8fc7\u4e86ISO17025:2005\u8ba4\u8bc1<\/p>\n\n\n\n

\u5728 USP\u4e2d\uff0c\u836f\u54c1\u540d\u5f55\u6309\u7167\u6cd5\u5b9a\u836f\u54c1\u540d\u79f0\u7684\u5b57\u6bcd\u987a\u5e8f\u6392\u5217\uff0c\u6bcf\u4e2a\u6761\u76ee\u901a\u5e38\u5305\u62ec\u836f\u54c1\u540d\u79f0\u3001\u7ed3\u6784\u5f0f\u3001\u5206\u5b50\u5f0f\u3001CAS \u767b\u8bb0\u53f7\u3001\u6210\u5206\u53ca\u542b\u91cf\u8bf4\u660e\u3001\u5305\u88c5\u4e0e\u8d2e\u85cf\u6761\u4ef6\u3001\u9274\u5b9a\u65b9\u6cd5\u3001\u5e72\u71e5\u5931\u91cd\u3001\u70bd\u707c\u6b8b\u6e23\u4ee5\u53ca\u68c0\u6d4b\u65b9\u6cd5\u7b49\u4fe1\u606f\u3002\u6b64\u5916\uff0c\u6b63\u6587\u540e\u8fd8\u63d0\u4f9b\u4e86\u5bf9\u5404\u7c7b\u836f\u54c1\u8fdb\u884c\u6d4b\u8bd5\u7684\u65b9\u6cd5\u4e0e\u8981\u6c42\uff0c\u4ee5\u53ca\u9488\u5bf9\u5404\u79cd\u836f\u7269\u7684\u4e00\u822c\u6027\u8981\u6c42\u901a\u5219\u3002\u4f5c\u4e3a\u7f8e\u56fd\u653f\u5e9c\u5236\u5b9a\u7684\u836f\u54c1\u8d28\u91cf\u6807\u51c6\u548c\u6280\u672f\u89c4\u8303\uff0cUSP \u4e0d\u4ec5\u662f\u836f\u54c1\u751f\u4ea7\u3001\u4f7f\u7528\u3001\u7ba1\u7406\u548c\u68c0\u9a8c\u7684\u91cd\u8981\u6cd5\u5f8b\u4f9d\u636e\uff0c\u4e5f\u662f\u786e\u4fdd\u836f\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u7684\u5173\u952e\u3002<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

\u4ea7\u54c1\u7279\u70b9\u4e0e\u4f18\u52bf<\/strong><\/p>\n\n\n\n

1.\u5168\u9762\u6027\u4e0e\u591a\u6837\u6027\uff1aUSP\u63d0\u4f9b\u8d85\u8fc73500\u79cd\u6807\u51c6\u54c1\uff0c\u6db5\u76d6\u4e86\u539f\u6599\u836f\u3001\u6742\u8d28\u3001\u836f\u7528\u8f85\u6599\u548c\u81b3\u98df\u8865\u5145\u5242\u7b49\u591a\u4e2a\u9886\u57df\u3002<\/p>\n\n\n\n

2.\u9ad8\u8d28\u91cf\u4e0e\u53ef\u4fe1\u5ea6\uff1aUSP\u6807\u51c6\u54c1\u7b26\u5408USP\u5404\u8bba\u8981\u6c42\uff0c\u7ecf\u8fc7\u591a\u4e2a\u72ec\u7acb\u5b9e\u9a8c\u5ba4\u7684\u4e25\u683c\u7814\u7a76\u548c\u8bc4\u4f30\uff0c\u786e\u4fdd\u68c0\u6d4b\u7ed3\u679c\u7684\u51c6\u786e\u6027\u548c\u53ef\u4fe1\u5ea6\u3002<\/p>\n\n\n\n

3.\u5feb\u901f\u53d1\u8d27\u4e0e\u4fbf\u6377\u8d2d\u4e70\uff1aUSP\u6807\u51c6\u54c1\u63d0\u4f9b\u672c\u5730\u5e93\u5b58\uff0c\u4fdd\u8bc1\u8fc5\u901f\u53d1\u8d27\uff0c\u540c\u65f6\u63d0\u4f9b\u4fbf\u6377\u7684\u8d2d\u4e70\u65b9\u5f0f\uff0c\u5982\u4e00\u952e\u7ed3\u8d26\u7b49\u3002<\/p>\n\n\n\n

4.\u5408\u89c4\u6027\uff1a\u4f7f\u7528USP\u6807\u51c6\u54c1\u8fdb\u884c\u836f\u7269\u7814\u53d1\u548c\u751f\u4ea7\uff0c\u6709\u52a9\u4e8e\u964d\u4f4e\u4eff\u5236\u836f\u7533\u62a5\uff08ANDA\uff09\u88ab\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u62d2\u7edd\u7684\u98ce\u9669\uff0c\u5e76\u7b26\u5408\u56fd\u9645\u836f\u5178\u6807\u51c6\u3002<\/p>\n\n\n\n

USP\u6807\u51c6\u7269\u8d28\u548c\u6807\u51c6\u54c1\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u3001\u98df\u54c1\u3001\u5316\u5986\u54c1\u7b49\u591a\u4e2a\u884c\u4e1a\uff0c\u7279\u522b\u662f\u5728\u836f\u7269\u7814\u53d1\u3001\u751f\u4ea7\u3001\u8d28\u91cf\u63a7\u5236\u548c\u76d1\u7ba1\u65b9\u9762\u53d1\u6325\u7740\u91cd\u8981\u4f5c\u7528\u3002\u8fd9\u4e9b\u6807\u51c6\u7269\u8d28\u548c\u6807\u51c6\u54c1\u4e0d\u4ec5\u6709\u52a9\u4e8e\u786e\u4fdd\u836f\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\u6027\uff0c\u8fd8\u4fc3\u8fdb\u4e86\u5168\u7403\u836f\u54c1\u5e02\u573a\u7684\u89c4\u8303\u5316\u548c\u6807\u51c6\u5316\u53d1\u5c55\u3002<\/p>\n\n\n\n

\u4e3b\u8425\u4ea7\u54c1<\/strong><\/p>\n\n\n\n

\u7f8e\u56fd\u836f\u5178\u7684\u6807\u51c6\u7269\u8d28\u662f\u5176\u6838\u5fc3\u4ea7\u54c1\u4e4b\u4e00\uff0c\u8fd9\u4e9b\u6807\u51c6\u7269\u8d28\u662f\u7279\u6027\u7279\u5f3a\u7684\u7269\u7406\u6837\u672c\uff0c\u88ab\u5236\u836f\u53ca\u76f8\u5173\u884c\u4e1a\u7528\u6765\u8fdb\u884c\u5404\u79cd\u6d4b\u8bd5\uff0c\u4ee5\u5e2e\u52a9\u9a8c\u8bc1\u836f\u54c1\uff08\u5305\u62ec\u836f\u54c1\u3001\u751f\u7269\u5236\u5242\u548c\u8f85\u6599\uff09\u3001\u98df\u7269\u8865\u5145\u5242\u548c\u98df\u54c1\u6210\u5206\u7684\u7279\u6027\u3001\u6548\u529b\u3001\u8d28\u91cf\u548c\u7eaf\u5ea6\u3002USP\u6cd5\u5b9a\u6807\u51c6\u7269\u8d28\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u51e0\u7c7b\uff1a<\/p>\n\n\n\n

1.\u539f\u6599\u836f\uff1a\u7528\u4e8e\u836f\u7269\u751f\u4ea7\u7684\u4e3b\u8981\u6d3b\u6027\u6210\u5206\u3002<\/p>\n\n\n\n

2.\u8f85\u6599\uff1a\u836f\u7269\u5236\u5242\u4e2d\u9664\u6d3b\u6027\u6210\u5206\u4ee5\u5916\u7684\u5176\u4ed6\u6210\u5206\uff0c\u5982\u586b\u5145\u5242\u3001\u9ecf\u5408\u5242\u7b49\u3002<\/p>\n\n\n\n

3.\u6742\u8d28\uff1a\u836f\u7269\u751f\u4ea7\u548c\u50a8\u5b58\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u4ea7\u751f\u7684\u975e\u6d3b\u6027\u6210\u5206\u3002<\/p>\n\n\n\n

4.\u964d\u89e3\u4ea7\u54c1\uff1a\u836f\u7269\u5728\u7279\u5b9a\u6761\u4ef6\u4e0b\uff08\u5982\u5149\u7167\u3001\u6e29\u5ea6\u7b49\uff09\u5206\u89e3\u4ea7\u751f\u7684\u5316\u5408\u7269\u3002<\/p>\n\n\n\n

5.\u98df\u54c1\u8865\u5145\u5242\uff1a\u65e8\u5728\u589e\u52a0\u98df\u54c1\u8425\u517b\u4ef7\u503c\u6216\u8865\u5145\u81b3\u98df\u4e2d\u8425\u517b\u7d20\u4e0d\u8db3\u7684\u7269\u8d28\u3002<\/p>\n\n\n\n

6.\u836f\u5178\u8bd5\u5242\uff1a\u7528\u4e8e\u836f\u7269\u5206\u6790\u3001\u68c0\u6d4b\u548c\u9274\u5b9a\u7684\u5316\u5b66\u8bd5\u5242\u3002<\/p>\n\n\n\n

\u6b64\u5916\uff0cUSP\u8fd8\u5411\u5206\u6790\u3001\u4e34\u5e8a\u3001\u5236\u836f\u548c\u7814\u7a76\u5b9e\u9a8c\u5ba4\u63d0\u4f9b\u300a\u98df\u54c1\u5316\u5b66\u6cd5\u5178\u300b\uff08Food Chemicals Codex\uff09\u4e2d\u89c4\u5b9a\u7684\u6807\u51c6\u7269\u8d28\u4ee5\u53ca\u7eaf\u54c1\uff08\u4f18\u8d28\u5316\u5b66\u6837\u54c1\uff09\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u7f8e\u56fd\u836f\u5178USP \u300a\u7f8e\u56fd\u836f\u5178\/\u56fd\u5bb6\u5904\u65b9\u96c6\u300b\uff08U.S. Pharmacopoeia \/ National Form […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[67],"tags":[],"_links":{"self":[{"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/posts\/101257"}],"collection":[{"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/comments?post=101257"}],"version-history":[{"count":1,"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/posts\/101257\/revisions"}],"predecessor-version":[{"id":101262,"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/posts\/101257\/revisions\/101262"}],"wp:attachment":[{"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/media?parent=101257"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/categories?post=101257"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.broadbio.com\/wp-json\/wp\/v2\/tags?post=101257"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}