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Research Article

Development and Validation of a Sterility Test Method for Large, Gentamicin-Containing Liposomes

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Pages 43-48 | Published online: 28 Sep 2008
 

Abstract

A method for testing the sterility of large, gentamicin-containing, egg phosphatidylcholine (EPC) liposome suspensions is described. The method consists of diluting the liposome formulation in four volumes of 1.5% triton X-100 (final EPC concentration in the detergent solution is approximately 10 mg/ml) and then filtering the cloudy suspension as outlined by the USP for the membrane filtration sterility test. The method was not bacteriocidal or fungicidal for the organisms tested.

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