This practice covers procedures for preparing and recording images of a suspension or suspensions of liposomes for the purpose of evaluating their shape and size distribution for quality assessment. The sample is to be vitrified in a liquid ethane slush onto specially prepared holey carbon electron microscope (EM) grids, and imaged in a cryo-holder placed in a cryo-capable electron microscope.
Liposomes make up ~26% of nano-related drug submissions. Some guidance is needed in the area of characterization.
Keywordselectron microscopy nanotechnology size shape liposome
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