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Volume 32 Issue 5
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2014  >  32(5): 368-371

ZHANG Guoqing, DU Jianhong, ZHU Hui, LIU Hui, FANG Chen. Methodology establishment and validation of microbial limit examination of diluted benzalkonium bromide solution[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(5): 368-371. doi: 10.3969/j.issn.1006-0111.2014.05.015
Citation: ZHANG Guoqing, DU Jianhong, ZHU Hui, LIU Hui, FANG Chen. Methodology establishment and validation of microbial limit examination of diluted benzalkonium bromide solution[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(5): 368-371. doi: 10.3969/j.issn.1006-0111.2014.05.015
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Methodology establishment and validation of microbial limit examination of diluted benzalkonium bromide solution

doi: 10.3969/j.issn.1006-0111.2014.05.015

  • Institute for Drug and Instrument Control, Chengdu Military Region, Chengdu 610017, China

  • Received Date: 2013-11-22
  • Rev Recd Date: 2014-05-29
  • Objective To establish a microbial limit examination method and a verified methodology for diluted benzalkonium bromide solution, and ensure the effectiveness of the method. Methods Microbial limit test of diluted benzalkonium bromide solution was used as the validation methodology according to the validation test requirements of appendix XI J of the second version of the "Chinese Pharmacopoeia" published in 2010. Results Membrane filtration method could be used for counting bacteria, mold and yeast count in the microbial limit examination of the diluted benzalkonium bromide solution; membrane filtration method could be adopted to control the bacteria. Conclusion Antibacterial activity of diluted benzalkonium bromide solution should be fully considered before examination when building its examination method through microbial limit methodology validation.
  • [1] 国家药典委员会.中华人民共和国药典2010年版二部[S].北京:中国医药科技出版社,2010:附录107-116.
    [2] 解放军总后勤部卫生部.中国人民解放军医疗机构制剂规范(2002年版)[S].人民军医出版社,2003:103-104,附录67-80.
    [3] 苏德模,马绪荣,许华玉,等. 药品微生物学检验技术[M].华龄出版社,2007:221-227.
    [4] 曲 萍,仇丽霞,赵思俊,等.卡波姆抑菌凝胶剂微生物限度检查方法的建立[J].药物分析杂志, 2013,33(8):1317-1321.
    [5] 应国红,邓 颖,冯丰凑.外用制剂微生物限度检查方法研究[J].中国药业,2008,17(21):32-33.
    [6] 孟丽丽,陆 娟,李晓波,等.烧伤搽剂微生物限度检查法的验证[J].中国药师,2011,14(5):746-747.
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Methodology establishment and validation of microbial limit examination of diluted benzalkonium bromide solution

doi: 10.3969/j.issn.1006-0111.2014.05.015
  • Institute for Drug and Instrument Control, Chengdu Military Region, Chengdu 610017, China
  • Received Date: 2013-11-22
  • Rev Recd Date: 2014-05-29

Abstract: Objective To establish a microbial limit examination method and a verified methodology for diluted benzalkonium bromide solution, and ensure the effectiveness of the method. Methods Microbial limit test of diluted benzalkonium bromide solution was used as the validation methodology according to the validation test requirements of appendix XI J of the second version of the "Chinese Pharmacopoeia" published in 2010. Results Membrane filtration method could be used for counting bacteria, mold and yeast count in the microbial limit examination of the diluted benzalkonium bromide solution; membrane filtration method could be adopted to control the bacteria. Conclusion Antibacterial activity of diluted benzalkonium bromide solution should be fully considered before examination when building its examination method through microbial limit methodology validation.

ZHANG Guoqing, DU Jianhong, ZHU Hui, LIU Hui, FANG Chen. Methodology establishment and validation of microbial limit examination of diluted benzalkonium bromide solution[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(5): 368-371. doi: 10.3969/j.issn.1006-0111.2014.05.015
Citation: ZHANG Guoqing, DU Jianhong, ZHU Hui, LIU Hui, FANG Chen. Methodology establishment and validation of microbial limit examination of diluted benzalkonium bromide solution[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(5): 368-371. doi: 10.3969/j.issn.1006-0111.2014.05.015
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