ASTM WK54872

    New Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering

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    Developed by Subcommittee: E56.02 | Committee E56 | Contact Staff Manager



    WK54872

    1. Scope

    1.1 This test method addresses the determination of nanoparticle size (equivalent sphere hydrodynamic diameter) using batch-mode (off-line) dynamic light scattering (DLS) in aqueous suspensions and establishes general procedures that are applicable to many commercial DLS instruments. This test method specifies best practices, including sample preparation, performance verification, data analysis and interpretation, and reporting of results. This test method includes additional general information for the analyst, such as recommended settings for specific media, potential interferences, and method limitations. Issues specific to the use of DLS data for regulatory submissions are addressed. 1.2 The procedures and practices described in this test method, in principle, may be applied to any particles that exhibit Brownian motion and are kinetically stable during the course of a typical experimental time frame. In practice, this includes particles up to 1000 nm in diameter, subject to limitations as described in this test method. 1.3 This test method does not provide test specimen preparation procedures for all possible materials and applications nor does it address synthesis or processing before sampling. The test specimen (suspension) preparation procedures should provide acceptable results for a wide range of materials and conditions. The analyst shall validate the appropriateness for their particular application. 1.4 This test method is applicable to DLS instruments that implement correlation spectroscopy. Analysts using instruments based on frequency analysis may still find useful information relevant to many aspects of the measurement process, including limits of applicability and best practices. On-line (flow-mode) DLS measurements are not treated here specifically and may have additional limitations or issues relative to batch-mode operation. 1.5 Units--The values stated in SI units are to be regarded as the standard. Where appropriate, c.g.s. 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 analyst to establish appropriate safety and health practices.


    Keywords

    dynamic light scattering; hydrodynamic size; light scattering; nanoparticle; photon correlation spectroscopy; particle size; particle size distribution; quasi-elastic light scattering; regulatory submission; regulatory science

    Rationale

    This standard is needed to facilitate regulatory review and oversight of nanoparticle-based biomedical products. Current standards do not meet the requirements and needs of regulatory agencies. This test method will also be used for quality control and performance verification by measurement laboratories and nanomaterial producers. Principal users will include the Food and Drug Administration, biomedical industry, nanomaterial producers, and analytical service providers.

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    06-14-2016

    Technical Contact:
    Vincent Hackley

    Item:
    001

    Ballot:
    E56 (20-01)

    Status:
    Ballot Item Approved as E3247-2020 and Pending Publication

    Item:
    002

    Ballot:
    E56 (20-03)

    Status:
    Ballot Item Approved as E3247-2020 and Pending Publication