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Verification of sterility test of ceftriaxone sodium for injection

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Author:
No author available
Journal Title:
China Medicine
Issue:
11
DOI:
10.3760/cma.j.issn.1673-4777.2012.11.047
Key Word:
注射用头孢曲松钠;无菌检查;薄膜过滤法;验证试验;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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