Subvisible Particles Detection in Parenteral Drugs

Parenteral drugs are delivered into the body by directly injecting into the intravenous, subcutaneous, or intramuscular routes. Subvisible particle counting in parenteral drugs is described in USP <788>, a common application for the AccuSizer SIS system. The same system can also be used for USP <789> for ophthalmic solutions and the new USP <787> test for therapeutic protein injections.

The USP <729> test for globule size distribution in lipid injectable emulsions calls for systems like the AccuSizer APS for Method II and the Nicomp DLS system for Method I.


Click the image above to watch a presentation on using the PSS AccuSizer to count and size particulate matter in parenteral drugs.


Read the sections below for additional information on these applications.

USP 729 Emulsion Size Testing

The size of the lipid droplets is critical because larger-size fat globules (>5 µm) can be trapped in the lungs and are also an indicator that the emulsion is destabilizing. The USP <729> test requires two analytical techniques: DLS or laser diffraction to measure the mean and standard deviation of the distribution and light obscuration…

USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections

The new USP <787> SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS test can be used as an alternative to USP<788>. USP <787> is meant for therapeutic protein injections, making changes for smaller test product volumes and smaller test aliquots. Here is a summary of how to test a sample following the new USP 787 procedure: Follow…

USP <788> Particle Counting

Parenteral drugs administered by injection to patients should be essentially free of visible particles. Sub-visible particles in parenteral drugs are detected using a light obscuration particle counter, microscopic inspection on a filter, or both. The light obscuration particle count test applies to large volume injections with total volume >100 mL unless specified in the individual…