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Verification of sterility test of ceftriaxone sodium for injection

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Author:
NIE Yu-qiong(Institute for Drug and Instrument Control,Health Department of General Logistics Department of People's Liberation Army,Beijing 100071,China)
GAO Jin(Institute for Drug and Instrument Control,Health Department of General Logistics Department of People's Liberation Army,Beijing 100071,China)
ZHANG Mei()
LIU Yan-e(Institute for Drug and Instrument Control,Health Department of General Logistics Department of People's Liberation Army,Beijing 100071,China)
GAO Jian-quan(Institute for Drug and Instrument Control,Health Department of General Logistics Department of People's Liberation Army,Beijing 100071,China)
Journal Title:
China Medicine
Issue:
Volume 07, Issue 11, 2012
DOI:
10.3760/cma.j.issn.1673-4777.2012.11.047
Key Word:
Ceftriaxone sodium for injection;Sterility test;Membrane-filter method;Verification test

Abstract: Objective To establish a method of sterility test of ceftriaxone sodium for injection.Methods The method was based on the verification of sterility test of Chinese Pharmacopoeia (2010 edition) and the membrane-filter method was used.Ten samples were dissolved in 8 ml sodium chloride solution (0.9%) with each transferred thoroughly to 400 ml sodium chloride solution (0.9%),then filtered through three layer membranes.Each filter was washed with 400 ml 0.1% peptone solution.The positive control bacteria was Escherichia coli.Results The result of verification test showed that the sample and negative control tubes had no growth of microorganism and the test and all of positive control tubes revealed growth of microorganism.It illustrated that the sample had no antimicrobial activity in this sample quantity and test condition.Conclusion The sterility test method is simple and feasible,which can be used in the sterility test of ceftriaxone sodium for injection.

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