WHITE PAPER | Determination of Particulate Contamination in Pharmaceutical Formulations

Particulate contamination has been the source of multiple concerns associated with pharmaceutical safety. Between 2018 – 2020, particulates caused approximately 10% of all recalls highlighted by the FDA, with a large proportion of these recalls associated with injectable drugs.

In this white paper, Dr. Stefan Heck, Intertek Reinach, describes the challenges of particulate identification, the regulatory context and with a series of case studies, will demonstrate suitable test strategies which may be applied depending on type and source of the observed particulate contamination.

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