USP Reference Standards for Subvisible Particles: What's Changing and Why it Matters

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The United States Pharmacopeia (USP) sets critical standards for controlling subvisible particulate matter in injectable drug products. This updated white paper summarizes current USP guidelines and highlights upcoming changes to USP <788> effective August 1, 2026, along with emerging guidance on silicone oil droplets (SiOPs). Learn how these developments impact compliance strategies and why Flow Imaging Microscopy (FIM) is essential for accurate particle characterization.


Why This White Paper Is Essential

  • Understand USP <787>, <788>, <789> requirements for subvisible particles.
  • Prepare for USP <788> harmonization changes: new flexibility in sample volumes, single-unit testing, and updated terminology.
  • Explore USP's proposed informational chapter on SiOPs and its implications for biologics.
  • See how FlowCam LO combines Light Obscuration and Flow Imaging Microscopy for direct, orthogonal analysis.

Download the updated white paper to learn how to meet today’s USP requirements and prepare for tomorrow’s standards with Flow Imaging Microscopy.

Download the White Paper