Article(id=1321425670593425545, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.09.003, 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=1761148800000, acceptedDateStr=2025-10-23, onlineDate=1792982030770, onlineDateStr=2026-10-26, pubDate=1778774400000, pubDateStr=2026-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982030770, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982030770, creator=13701087609, updateTime=1792982030770, 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=911, endPage=919, ext={EN=ArticleExt(id=1321425670752809099, articleId=1321425670593425545, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Harmonization of the disintegration test between Chinese Pharmacopoeia and ICH Q4B Annex 5(R1), columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The disintegration test is a critical method and means for controlling the critical quality attributes of solid dosage forms. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) harmonized the disintegration test methods of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP), resulting in the ICH Q4B Guideline Annex 5, which allows for mutual recognition within the ICH region. The 〈0921 Disintegration Test〉 in the 2025 edition of the Chinese Pharmacopoeia (ChP) has been harmonized with ICH Q4B Annex 5 (R1), achieving consistency with respect to apparatus and general procedure; acceptance criteria according to ICH and CHP are described in parallel; and the requirements for specific dosage forms as per the 2020 edition were retained. Additionally, the framework of 〈0921 Disintegration Test〉 has been revised to align with the ICH guideline, ensuring harmonization with international standards. This revision not only considers the historical inheritance of the Chinese Pharmacopoeia and the practical needs of China's pharmaceutical industry but also achieves international harmonization. This article provides a detailed comparison of the differences in apparatus and procedure between 〈0921 Disintegration Test〉 in the Chinese Pharmacopoeia and ICH Q4B Annex 5 (R1). Research on the harmonization of disintegration test methods across the ICH tripartite regions (EP, USP, JP) was carried out, including the comparison of disintegration test results, investigation of statistical data simulation for acceptance criteria, and the interpretation of the background, approach, and considerations behind the harmonization of 〈0921 Disintegration Test〉 with ICH. The aim is to enhance the understanding of the revisions to the 〈0921 Disintegration Test〉 in the 2025 edition and provide supportive reference for both the pharmaceutical industry and regulatory authorities.

, authors=Ying GENG¹, Xiao-fen WANG², Ning-yi WEI¹, Qi-ming ZHANG¹, Xin-yi XU³, Yue SHANG³, Yu WU⁴, Zi-feng ZHU⁵, Ping LIAO⁶, Quan YANG⁷, Gang HOU⁸, Tian-shou YANG^{2, *}, Hua CHEN^{1, *}, authorsList=Ying GENG, Xiao-fen WANG, Ning-yi WEI, Qi-ming ZHANG, Xin-yi XU, Yue SHANG, Yu WU, Zi-feng ZHU, Ping LIAO, Quan YANG, Gang HOU, Tian-shou YANG, Hua CHEN, authorCompany=null, correspAuthors=Tian-shou YANG, Hua CHEN, 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=1321425670962524300, articleId=1321425670593425545, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《中华人民共和国药典》崩解时限检查法与ICH Q4B附录5（R1）通则协调, 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=

崩解时限检查法是一种对固体制剂关键质量属性控制的重要方法及手段。ICH协调了美国药典（USP）、欧洲药典（EP）和日本药局方（JP）的崩解时限检查法，形成Q4B指导原则附件5（Annex 5），在ICH区域内互换使用。《中华人民共和国药典》2025年版〈0921崩解时限检查法〉与ICH Q4B附录5（R1）通则进行了协调，对于仪器装置、通用测定方法协调一致，判定法并行收载，具体制剂剂型要求保留原2020年版规定，同时根据ICH通则体例，对〈0921崩解时限检查法〉体例进行了修订，与ICH同步协调。此次修订既兼顾了《中华人民共和国药典》的历史情况，考虑了中国制药行业的实际要求，又实现了与国际协调接轨。本文详细对比《中华人民共和国药典》〈0921崩解时限检查法〉与ICH Q4B附录5（R1）通则仪器设备/测定法的差异，结合ICH三方辖区EP、USP、JP中崩解时限检查法协调情况，通过崩解时限测试结果对比、统计学判定法数据模型等研究方式，对〈0921崩解时限检查法〉协调背景/方式/考量等进行阐述和分析，为读者对〈0921崩解时限检查法〉修订内容的理解提供参考，为产业界和药品监管机构提供支持。

, authors=耿颖¹, 王晓芬², 魏宁漪¹, 张启明¹, 徐昕怡³, 尚悦³, 吴娱⁴, 朱子丰⁵, 廖萍⁶, 杨泉⁷, 侯刚⁸, 杨天寿^{2, *}, 陈华^{1, *}, authorsList=耿颖, 王晓芬, 魏宁漪, 张启明, 徐昕怡, 尚悦, 吴娱, 朱子丰, 廖萍, 杨泉, 侯刚, 杨天寿, 陈华, authorCompany=null, correspAuthors=杨天寿, 陈华, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=TDsqyXqN2+z+23u4uiDmQQ==, magXml=qmLcnpgMZGQddZTFaawLFQ==, pdfUrl=null, pdf=FUNqsNN3iqJyKD5oEYtJ1g==, pdfFileSize=1654453, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=ZJC2z+Qvjd7uOzNlP0Koyw==, mapNumber=null, fund=null)}, authors=[Author(id=1321425673361666214, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425670593425545, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=gengying@nifdc.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425673453940904, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425670593425545, authorId=1321425673361666214, language=EN, stringName=Ying GENG, firstName=Ying, middleName=null, lastName=GENG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹National Institutes for Food and Drug Control, Beijing 102629, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425673525244073, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425670593425545, authorId=1321425673361666214, language=CN, stringName=耿颖, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=¹, address=¹中国食品药品检定研究院，北京 102629, bio={"content":"

耿颖，女，副研究员，研究方向：化学药品质量控制和研究。E-mail: gengying@nifdc.org.cn。

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耿颖，女，副研究员，研究方向：化学药品质量控制和研究。E-mail: gengying@nifdc.org.cn。

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