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Description of ASTM-E3409 2024ASTM E3409-24Active Standard: Standard Test Method for Analysis of Liposomal Drug Formulations Using Multidetector Asymmetrical-Flow Field-Flow FractionationASTM E3409Scope 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 Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. Keywords asymmetrical-flow field-flow fractionation; doxorubicin; drug product; dynamic light scattering; fractogram; hydrodynamic radius; lipid; liposome; multi-angle light scattering; particle size; radius of gyration; shape factor; UV-visible absorbance; ICS Code ICS Number Code n/a DOI: 10.1520/E3409-24 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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