ASTM WK74514

    New Practice for Measurement of Particulate Matter in Pharmaceuticals using Automated Membrane Microscopy

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    Developed by Subcommittee: E55.03 | Committee E55 | Contact Staff Manager



    WK74514

    1. Scope

    The proposed standard practice focuses on the measurement of particulate matter extracted from pharmaceutical processes and products. Described is the procedure for preparation of samples of particles on filter membranes, and the procedures required to reliably analyze the number of particles along with the size parameters of the particles on the filter membrane using automated microscopy methods (microscopic scanning and image analysis of particles on a filter membrane).


    Keywords

    microscopy; pharmaceutical

    Rationale

    no existing standard practice for this topic

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

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    10-26-2020

    Technical Contact:
    Klaus Wormuth

    Status:
    Draft Under Development