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

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-I00 (final EPC concentration in the detergent solution is approximately I0 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.