ASTM E3409 : 24

1.1 This test method describes a measurement procedure to reproducibly separate component size populations present within liposomal drug formulations and to characterize their associated size and size distribution. The method can also yield information on the shape and physical stability of the liposomes and is applicable to measurements in the presence of serum proteins. Fractions can be collected for off-line analysis using various techniques not specified in this test method.

1.2 This test method applies to uni-lamellar and multi-lamellar liposomes that are designed for drug delivery and which are dispersed in a native solution that is aqueous in nature. The method is generally applicable over a particle size range (radius) of approximately 10 nm to 250 nm, and for injected lipid mass from 20 µg to 200 µg.

1.3 This test method is based on the multi-detector asymmetrical-flow field-flow fractionation (MD-AF4) technique as configured on a typical commercial instrument platform with online detectors such as multi-angle (static) light scattering (MALS), dynamic light scattering (DLS), ultraviolet-visible (UV-Vis) absorbance, and differential refractive index (dRI) (1).2

1.4 This method does not address liposome composition. Refer to Test Methods E3297, E3323, or E3324 for lipid quantification.

1.5 Units—The values stated in SI units are to be regarded as standard. Where appropriate, cgs units are given in addition to SI.

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International StandardDetails, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.