药典委公示0512高效液相色谱法标准草案灵敏度、分离度等调整

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class="crumbs"> <a href="//www.antpedia.com" target="_blank" title="分析测试百科网">分析测试百科网</a> <em>></em> <a href="https://www.antpedia.com/news/" target="_blank" title="行业资讯">行业资讯</a> <em>></em> <a href="https://www.antpedia.com/news/1033"><span>标准</span></a> </div> <div class="centerSide"> <h1 class="articleTitle">药典委公示0512高效液相色谱法标准草案灵敏度、分离度等调整</h1> <div class="articleModule"> <div class="message details-message"> <div class="time">2023.9.18</div> <div class="visit" id="visit"></div> </div> <div class="articleContent"> <p>　　　　2022年底，国家药典委员会发布《中国药典》（2025年版）编制大纲的<A class="msg_tagshow2" href="/standard/5568463.html" target=_blank>通知</A>。《通知》显示，到2025年，全面完成新版《中国药典》编制工作。符合中医药特点的中药标准进一步完善，化学药品、生物制品、药用辅料和药包材标准达到或基本达到国际先进水平，药品质量控制和安全保障水平明显提升。　</p><p style="text-align:center;"><img src="https://i5.antpedia.com/attachments/2023/09/105659_202309181021102.jpg" alt="105659_202309181021102.jpg"></p><p>　　近日，国家药典委员会公布了一批方法通则的修订草案，涉0512高效液相色谱法标准草案、毛细管电泳法标准草案、0931溶出度与释放度测定法标准草案、分析仪器确证指导原则标准草案、光学分析法标准草案、扫描电子显微镜法标准草案等。</p><p>　　其中，<strong><span style="color:rgb(192,0,0);">关于0512 高效液相色谱法标准草案的公示</span></strong>，国家药典委员会相关专业委员会进行了研讨，在第一次公示稿的基础上修订了部分内容，<strong><span style="color:rgb(192,0,0);">主要为允许调整的色谱参数及范围表中流速的要求、分离度计算公式、灵敏度要求等</span></strong>，并使文字表述更加规范。</p><p style="text-align:center;"><img src="https://i5.antpedia.com/attachments/2023/09/105659_202309181021103.jpg" alt="105659_202309181021103.jpg"></p><p style="text-align:center;"><span style="font-family:'黑体', SimHei;">分离度计算公式调整</span></p><p style="text-align:center;"><img src="https://i5.antpedia.com/attachments/2023/09/105659_202309181021104.jpg" alt="105659_202309181021104.jpg"></p><p style="text-align:center;"><span style="font-family:'黑体', SimHei;">灵敏度要求调整</span></p><p style="text-align:center;"><img src="https://i5.antpedia.com/attachments/2023/09/105659_202309181021105.jpg" alt="105659_202309181021105.jpg"></p><p style="text-align:center;"><span style="font-family:'黑体', SimHei;">外标法调整</span></p><p style="text-align:center;"><img src="https://i5.antpedia.com/attachments/2023/09/105659_202309181021106.jpg" alt="105659_202309181021106.jpg"></p><p style="text-align:center;"><span style="font-family:'黑体', SimHei;">校正因子计算调整</span></p><p>通知原文：</p><p style="text-align:center;"><strong>关于0512 高效液相色谱法标准草案的公示</strong></p><p>　　我委拟修订《中国药典》0512高效液相色谱法。为确保标准的科学性、合理性和适用性，现将拟修订的《中国药典》0512高效液相色谱法第二次公示稿公示征求社会各界意见（详见附件）。公示期自发布之日起一个月。请认真研核，若有异议，请及时来函提交反馈意见，并附相关说明、实验数据和联系方式。相关单位来函需加盖公章，个人来函需本人签名，同时将电子版上传至【公示反馈】附件中。</p><p>　　公示期满未回复意见即视为对公示标准草案无异议。<br></p><p style="line-height:16px;"><A style="font-size:12px;color:#0066cc;" href="https://www.antpedia.com/attachments/att/file/20230918/1695003817184609.pdf" title="附件2 0512高效液相色谱法第二次公示稿修改说明.pdf">附件2 0512高效液相色谱法第二次公示稿修改说明.pdf</A></p><p style="line-height:16px;"><A style="font-size:12px;color:#0066cc;" href="https://www.antpedia.com/attachments/att/file/20230918/1695003817392371.pdf" title="附件1 0512高效液相色谱法公示稿（第二次）.pdf">附件1 0512高效液相色谱法公示稿（第二次）.pdf</A></p><p><br></p><p>　　</p> <div class="no-thumbs-up">  <span></span> </div> <div class="message details-message"> <div class="keyword"> <a href="https://s.antpedia.com/3/色谱" target="_blank" class="highlight" title="色谱">色谱</a><a href="https://s.antpedia.com/3/标准" target="_blank" class="highlight" title="标准">标准</a><a href="https://s.antpedia.com/3/高效液相" target="_blank" class="highlight" title="高效液相">高效液相</a><a href="https://s.antpedia.com/3/中国药典" target="_blank" class="highlight" title="中国药典">中国药典</a> </div> <div class="source">国家药典委员会</div> <div class="like"> <a href="#" class="reward_a big-link" data-reveal-id="myModal-reward" title="喜欢作者">喜欢作者</a> <a href="javascript:" class="invitation_a" title="我要约稿">我要约稿</a> </div> <div class="next-article"> <a href="//www.antpedia.com/batch.common.php?action=viewnews&op=up&itemid=3087318&catid=1033" 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