Article(id=1236369015954789025, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369012058288373, articleNumber=null, orderNo=null, doi=null, 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=1668096000000, acceptedDateStr=2022-11-11, onlineDate=1772702944028, onlineDateStr=2026-03-05, pubDate=1693324800000, pubDateStr=2023-08-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772702944028, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772702944028, creator=13701087609, updateTime=1772702944028, updator=13701087609, issue=Issue{id=1236369012058288373, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='16', pageStart='1593', pageEnd='1696', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772702943100, creator=13701087609, updateTime=1772703272680, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236370394492490265, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369012058288373, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236370394496684570, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369012058288373, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1677, endPage=1683, ext={EN=ArticleExt(id=1236369016181281449, articleId=1236369015954789025, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Establishment of the national reference standards of 1,1,1,2-tetrafluoroethane as the excipient of medicinal aerosol and its impurities, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To develop the national reference standards of 1,1,1,2-tetrafluoroethane as the excipient of medicinal aerosol and its impurities thus to improve the standard of quality control.
Methods: The national reference standards of 1,1,1,2-tetrafluoroethane and its main impurities 1,1,2,2-tetrafluoroethane, pentafluoroethane, pentafluorochloroethane and 1,1,1-trifluoroethane were sub-packaged in liquid state directly. The structures were confirmed by IR, MS and MR spectroscopy, the moisture was determined by Coulomb method, the tightness of the package was confirmed by immersion in water. The content of each substance was calculated by mass balance method．Homogeneity and stability were investigated by F test and linear fitting respectively, and the content of 1,1,1,2-tetrafluoroethane was confirmed by multiple laboratories simultaneously.
Results: The contents of 1,1,1,2-tetrafluoroethane, 1,1,2,2-tetrafluoroethane, pentafluoroethane, pentafluorochloroethane and 1,1,1-trifluoroethane were 100.0%, 99.9%, 99.7%, 99.2%, and 99.9%, respectively, with good homogeneity and stability.
Conclusion: In this study, the national reference standards of 1,1,1,2-tetrafluoroethane and its main impurities were developed for the first time, where 1,1,1,2-tetrafluoroethane can be applied for content determination, and the other substances can be applied for the inspection of related substances.
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目的： 研制药用气雾剂辅料1，1，1，2-四氟乙烷及其主要杂质的国家对照品，为加强其质量控制提供依据。
方法： 对1，1，1，2-四氟乙烷及其主要杂质1，1，2，2-四氟乙烷、五氟乙烷、五氟氯乙烷、1，1，1-三氟乙烷进行液态直接分装，采用IR，MS，MR技术进行结构确证，库仑法测定水分，闭水法测试包装密封性，质量平衡法确定各物质含量，并分别用F检验和线性拟合进行均匀性、稳定性考察，同时对主成分1，1，1，2-四氟乙烷进行多家实验室协作标定定值。
结果： 研制的1，1，1，2-四氟乙烷及其主要杂质1，1，2，2-四氟乙烷、五氟乙烷、五氟氯乙烷、1，1，1-三氟乙烷标准值分别为100.0%，99.9%，99.7%，99.2%，99.9%，具有良好的均匀性和稳定性。
结论： 本研究首次制备了1，1，1，2-四氟乙烷及其主要杂质国家对照品，其中1，1，1，2-四氟乙烷可用作含量测定用对照品，其他物质可作为有关物质检查用对照品。
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孙会敏，男，研究员，主要从事药用辅料和药包材质量控制研究。联系电话：(010)53852486，E-mail:
sunhm@126.com。
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赵燕君，女，助理研究员，主要从事气雾剂抛射剂质量控制研究。联系电话：(010)67095608，E-mail: zhaoyanjun24@163.com。
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赵燕君，女，助理研究员，主要从事气雾剂抛射剂质量控制研究。联系电话：(010)67095608，E-mail: zhaoyanjun24@163.com。
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