Article(id=1322246449522389511, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, 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=1602864000000, acceptedDateStr=2020-10-17, onlineDate=1793177719717, onlineDateStr=2026-10-28, pubDate=1623686400000, pubDateStr=2021-06-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177719717, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177719717, creator=13701087609, updateTime=1793177719717, updator=13701087609, issue=Issue{id=1322246381633389353, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='11', pageStart='961', pageEnd='1056', issueExtLink='null', onlineDate='null', pubDate='1623686400000', pubDateStr='2021-06-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177703531, creator='13701087609', updateTime=1793178125547, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248152208486593, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248152212680898, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246381633389353, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1038, endPage=1047, ext={EN=ArticleExt(id=1322246449677578760, articleId=1322246449522389511, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of polymer impurities in cefoxitin sodium injection, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish a determination method of polymer impurities in cefoxitin sodium injection.
Methods: Cefoxitin sodium was dissolved in water to prepare stock solution of cefoxitin sodium polymer. High performance size exclusion chromatography (HPSEC, TSK-gel G2000SWxl) and column switching-LC/MSn were applied to separate and deduce the poor retention impurities in the stock solution and to evaluate the specificity of HPSEC method. A new RP-HPLC method for polymer analysis was established with a Shimadzu Inertsil Ph-3 column, using a gradient elution by phosphate buffer solution (pH 3.2)-acetonitrile-methanol, and the method was validated.
Results: Several cefoxitin sodium polymers were identified in stock solution of cefoxitin sodium polymer, 4 small molecular impurities were also detected. Polymer impurities were liable to co-elute with small molecular impurities by HPSEC method, making a poor quantification accuracy and specificity. Two indicative polymer impurities were detected by RP-HPLC method with an effective specificity.
Conclusion: HPSEC method was not suitable for the quality control of polymer impurities in cefoxitin sodium injection, while the new established RP-HPLC method was specific, which could effectively control the polymer impurities. Cefoxitin sodium polymer stock solution could be used to identify polymer peaks as the system suitability solution.
, authors=Jin LI, Shang-chen YAO, Li-hui YIN, Ming-zhe XU, Chang-qin HU, authorsList=Jin LI, Shang-chen YAO, Li-hui YIN, Ming-zhe XU, Chang-qin HU, authorCompany=null, correspAuthors=Ming-zhe XU, 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=1322246450117980681, articleId=1322246449522389511, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=注射用头孢西丁钠的聚合物杂质分析, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 建立注射用头孢西丁钠聚合物杂质的分析方法。
方法： 采用水为溶剂制备头孢西丁钠聚合物浓溶液；采用高效凝胶色谱法（HPSEC，TSK G2000 SWxl）和柱切换-LC/MSn法对头孢西丁钠聚合物浓溶液的弱保留值杂质进行分离和结构鉴定，并评估HPSEC法分析聚合物杂质的专属性；采用Shimadzu Inertsil Ph-3型色谱柱，以磷酸盐缓冲液溶液（pH 3.2）-甲醇-乙腈为流动相进行梯度洗脱，建立头孢西丁钠聚合物的反相高效液相色谱（RP-HPLC）分析方法，并进行方法学验证。
结果： 在头孢西丁钠聚合物浓溶液中检出出头孢西丁钠聚合物杂质，以及4个小分子杂质；HPSEC法分离头孢西丁钠聚合物杂质时，小分子杂质与聚合物杂质共出峰，方法专属性与定量准确性差；RP-HPLC法分析头孢西丁钠聚合物杂质时，能够检出2种头孢西丁钠指针性聚合物杂质，专属性好。
结论： HPSEC法不能对头孢西丁钠的聚合物杂质进行有效质控，建立的RP-HPLC法分析头孢西丁钠聚合物杂质的专属性良好，可将头孢西丁钠聚合物浓溶液作为聚合物杂质系统适用性溶液。
, authors=李进, 姚尚辰, 尹利辉, 许明哲, 胡昌勤, authorsList=李进, 姚尚辰, 尹利辉, 许明哲, 胡昌勤, authorCompany=null, correspAuthors=许明哲, authorNote=
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李进，男，主任药师，主要从事抗生素药物的杂质谱研究。联系电话：（010）53851560，E-mail：medjinli@126.com。
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李进，男，主任药师，主要从事抗生素药物的杂质谱研究。联系电话：（010）53851560，E-mail：medjinli@126.com。
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