Contaminant identification is of great concern to the pharmaceutical and medical device industry. Therefore, it is critical to understand and find a potential contaminant’s origin quickly. Two contaminant identification case studies will be presented. The use of multiple analytical techniques is paramount to determining a contaminant’s identity. These case studies include analytical techniques such as Fourier Transform Infrared Spectroscopy (FT-IR), Scanning Electron Microscopy Energy Dispersive X Ray Spectroscopy (SEM/EDS), and Gas Chromatography Mass Spectrometry (GC/MS).
The first case study is a contaminant identification of a brown material present on a pharmaceutical tablet. This brown material was the source of a potential field recall of an entire lot of a drug product. After isolation and rush analysis, the contaminant was identified, it clearly came from an external source at the consumer end and a field recall was unnecessary for the product.