DETECTION AND ANALYSIS OF MICROPLASTICS IN PHARMACEUTICAL PRODUCTS

Microplastics (MPs) are emerging contaminants of environmental and public-health concern, with increasing attention to their potential presence in pharmaceutical products and healthcare materials. Pharmaceutical manufacturing involves polymers in packaging, tubing, filters, containers, and processing equipment, which may contribute to particle generation and contamination during production, handling, transportation, and storage. Reliable detection requires complementary analytical techniques to characterize particle size, morphology, polymer identity, and mass concentration. Microscopy, FTIR, Raman spectroscopy, SEM, Py-GC/MS, and TED-GC/MS provide complementary information for microplastic identification and quantification. Recently developed matrix-relevant reference materials containing polypropylene in water-soluble tablets offer a valuable approach to pharmaceutical method development and validation. Furthermore, microplastics and nanoplastics may enter the human body through pharmaceutical products and medical procedures, although exposure levels and clinical implications remain insufficiently established. Standardized analytical methods, appropriate reference materials, and effective contamination-control strategies are therefore essential for reliable pharmaceutical analysis and future risk assessment.