Article(id=1321425659616931884, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.09.002, 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=1761580800000, acceptedDateStr=2025-10-28, onlineDate=1792982028154, onlineDateStr=2026-10-26, pubDate=1778774400000, pubDateStr=2026-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982028154, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982028154, creator=13701087609, updateTime=1792982028154, 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=903, endPage=910, ext={EN=ArticleExt(id=1321425659990224941, articleId=1321425659616931884, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Study on the harmonization of weight (filling) variation test of Chinese Pharmacopoeia with ICH Q4B Annex 6 with respect to the harmonization consideration and statistical simulation, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Weight (filling) variation is an important critical quality attribute for pharmaceutical preparations, and is one of the critical aspects for the uniformity of dosage unit testing. In the ICH tripartite pharmacopoeias (USP, EP and JP), the harmonized general chapter on uniformity of dosage units (ICH Q4B Annex 6), utilizing a unified attribute and variable sampling plan. In General Requirements for Preparations of Chinese Pharmacopoeia, the Weight (Filling) Variation test has always used an attribute sampling plan, and there are differences with the Weight (Filling) Variation test in the ICH general chapter on uniformity of dosage units in terms of the preparation scope, sampling plan, and acceptance criteria. After the harmonization process with ICH Q4B, the newly added general chapter 〈0940 Uniformity of Dosage Units〉 was incorporated in Chinese Pharmacopoeia 2025 edition. In this paper, the harmonization consideration including the preparation scope, sampling plan and acceptance criteria was reviewed and interpreted in detail for Weight (Filling) Variation test described both in 〈General Requirements for Preparations〉 and in 〈0940 Uniformity of Dosage Units〉. The harmonization with ICH can further improve China's drug regulatory capacity and facilitate drug quality control to align with international standards.

, authors=Ying GENG¹, Rui DING², Ning-yi WEI¹, Qi-ming ZHANG¹, Xin-yi XU³, Yue SHANG³, Ping LIAO⁴, Quan YANG⁵, Jia-nan LIU⁶, Ling MA^{2, *}, Hua CHEN^{1, *}, authorsList=Ying GENG, Rui DING, Ning-yi WEI, Qi-ming ZHANG, Xin-yi XU, Yue SHANG, Ping LIAO, Quan YANG, Jia-nan LIU, Ling MA, Hua CHEN, authorCompany=null, correspAuthors=Ling MA, 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=1321425660220911662, articleId=1321425659616931884, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《中华人民共和国药典》重（装）量差异检查法与ICH Q4B附录6通则协调考虑及统计学数据模拟研究, 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=

重（装）量差异是药品的一个重要的关键质量属性，为剂量单位均匀性检查的一种方式。ICH三方辖区药典：美国药典、欧洲药典和日本药局方经协调后统一的《单位剂量均匀性检查》通则中，重（装）量差异采用计数型+计量型方式进行判定。我国药典的〈制剂通则〉中重（装）量差检查法一贯采用计数型判定方式，与ICH《单位剂量均匀性检查》通则中的重（装）量差异检查法在应用范围、抽样原则和判定方式上存在差异。本文详细介绍了《中华人民共和国药典》2025年版新增通则〈0940单位剂量均匀性检查法〉和〈制剂通则〉中重（装）量差异检查法的应用范围、统计学原理和进行ICH协调的情况及其考量。新增通则〈0940单位剂量均匀性检查法〉中对重（装）量差异检查方法更加科学合理，与ICH的协调可进一步提高我国药品的监管能力，促进药品质量控制与国际接轨。

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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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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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