USP 1788 2022 Revision Overview - Video

In May 2021 a revision to USP 1788, Methods for Determination of Subvisible Particulate Matter, was issued. It replaced the existing guidance contained in previous versions of USP 1788 (2011), which covered only the testing requirements for Optical Light Obscuration testing and Microscope testing – carry over from previous USP 788. This video looks at the holistic view of finished product contaminants, and how they should be investigated. USP 1788 provides guidance to better describe the process around understanding why the current limits and methods prescribed in USP 788 are applied.