Article(id=1321425647457645558, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.09.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1728316800000, acceptedDateStr=2024-10-08, onlineDate=1792982025255, onlineDateStr=2026-10-26, pubDate=1778774400000, pubDateStr=2026-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982025255, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982025255, creator=13701087609, updateTime=1792982025255, updator=13701087609, issue=Issue{id=1321425625915707977, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='9', pageStart='897', pageEnd='1008', issueExtLink='null', onlineDate='null', pubDate='1778774400000', pubDateStr='2026-05-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982020119, creator='13701087609', updateTime=1792983090252, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430114441745406, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430114441745407, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=897, endPage=902, ext={EN=ArticleExt(id=1321425647868687351, articleId=1321425647457645558, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=International harmonization research on the bacterial endotoxin test in the Chinese Pharmacopoeia and ICH Q4B, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The bacterial endotoxin test (BET) is a key quality control method for controlling the pyrogen risk of injectable products and other sterile drugs. With the acceleration of the global integration in drug research and development, production and regulation, the harmonization of testing methods across various pharmacopoeias has become an inevitable trend. ICH Q4B guideline Annex 14 provides a harmonized assessment of the BET chapters in the United States Pharmacopeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP), and recommends their interchangeable use within the ICH region. The Pharmacopoeia of the People's Republic of China (ChP), as China's national drug standard, historically established its BET method based on the USP and has undergone continuous revisions to align with ICH harmonization efforts, gradually achieving international alignment. This article aims to conduct a detailed comparative analysis of the main differences between the BET in ChP 2020 edition and the ICH harmonized text, based on ICH Q4B Annex 14 and the relevant chapters of the USP, EP and JP, and to explain the background, principles, main content, and ICH Q4B harmonization considerations underlying the revision of the BET in the ChP 2025 edition. The study shows that the BET in the ChP 2025 edition further converges with the ICH harmonized text in terms of method description format, requirements for revalidation of limulus amebocyte lysate (LAL) reagents sensitivity, and certain calculation parameters. At the same time, considering China's national conditions and drug safety, it retains Chinese characteristics in aspects such as water for testing requirements, the average body weight standard for calculating endotoxin limits, gel-clot interference test, and retest requirements for the limit test. This revision reflects the ChP's principle of actively participating in international harmonization while enhancing scientific rigor and international competitiveness of standards, while also taking into account domestic regulatory practices and public health, thereby laying a more solid foundation for achieving mutual recognition in drug regulation.

, authors=Tong CAI¹, Hua GAO¹, Kai-yong HE², Ran ZHU³, Yu-sheng PEI^{1, *}, authorsList=Tong CAI, Hua GAO, Kai-yong HE, Ran ZHU, Yu-sheng PEI, authorCompany=null, correspAuthors=Yu-sheng PEI, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1321425649118589945, articleId=1321425647457645558, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《中华人民共和国药典》细菌内毒素检查法与ICH Q4B的国际协调研究, columnId=1321425648233591800, journalTitle=中国新药杂志, columnName=中国药品质量检验检测的国际化协调与思考, runingTitle=null, highlight=null, articleAbstract=

细菌内毒素检查法（bacterial endotoxin test, BET）是控制注射剂及其他无菌药品热原风险的关键质量控制方法。随着全球药品研发、生产和监管一体化进程的加速，各国药典中检测方法的协调统一已是大势所趋。ICH发布的Q4B指导原则附件14（Annex 14）对美国药典（USP）、欧洲药典（EP）和日本药局方（JP）的BET章节进行了协调评估，推荐在ICH区域内互换使用。《中华人民共和国药典》（ChP）作为中国的国家药品标准，其BET方法在历史上参照USP制定，并随着ICH协调进展不断修订，逐步与国际接轨。本文旨在基于ICH Q4B Annex 14及USP、EP、JP的相关章节，深入比较分析ChP 2020年版BET与国际协调文本的主要差异，阐述ChP 2025年版BET修订的背景、原则、主要内容及其与ICH Q4B协调的考量。研究表明，ChP 2025年版BET在方法描述体例、鲎试剂灵敏度复核要求、部分计算参数等方面进一步与ICH协调文本趋同，同时基于中国国情和用药安全考虑，在检查用水要求、内毒素限值计算的人均体重标准、凝胶法干扰试验及限度试验复试要求等方面保留了中国特色。此次修订体现了ChP在积极参与国际协调、提升标准科学性和国际先进性的同时，兼顾国内监管实践和公众健康的原则，为实现药品监管的国际互认奠定更坚实的基础。

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蔡彤，女，硕士，主任药师，主要从事药检药理研究工作。E-mail: teddyct@163.com。

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蔡彤，女，硕士，主任药师，主要从事药检药理研究工作。E-mail: teddyct@163.com。

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