Analytical Strategies to Identify Particulate Contamination in Pharmaceutical Products

Particulate contamination has been the source of multiple concerns associated with pharmaceutical safety. Between Oct 2018 – Jan 2024, foreign particulate matter contributed to roughly 9% of FDA drug product recalls, with a large proportion of these recalls associated with injectable drugs. 

In this white paper, Dr. Peter Muehlschlegel, Project Manager Analytical Testing, addresses the regulatory context and challenges of particulate identification. Dr. Muehlschlegel introduces effective testing strategies through a series of case studies, offering practical solutions based on the type and source of observed particulate contamination.

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