Are Raw Material Contaminants Compromising Your Final Product?
Rapid Identification of Unknown Plastics Raw Material Impurities by Accurate Mass Spectrometry and MassFrontier Spectral Interpretation Software
Plastics are fundamental constituents of biomedical devices and of containers and closures (C&Cs) used in packaging of parenteral therapeutics. Leachables and extractables (L&E) residues from these plastics are a common concern of regulated medical industries. Pharmaceutical, biomedical device and therapeutic biologics all require in-depth characterization of residual analytes (ISO 10993-18:2005 and 10993-13:2010) detected in their plastic component leachates and extracts.
Plastic additives such as antioxidants, heat stabilizers, UV absorbers, and mold release agents are common L&E residuals released by plastics. Another obvious, but somewhat neglected source of plastic residuals are plastic contaminants - not prescribed additives –but compounds inadvertently introduced during plastics manufacturing. This case study focuses on the chemical identification and quantification of an acrylic plastic L&E residual compound which was introduced into the plastic as a low level contaminant of one of the monomer raw materials used in the acrylic polymerization manufacturing step.The study highlights how a low level contaminant of a raw material can become a prominent L&E residual, and how mining of analytical data with sophisticated software tools helps to uncover its origin and structure.
In practice, a minimum analytic characterization of plastics extracts for regulatory purposes includes liquid chromatography with UV detection(LC/UV). Low concentration plastic residuals analyzed with LC/UV can yield intense UV signals. However, identification and quantification, which are often needed to support product risk analysis requirements codified in numerous international regulatory guidances (ISO 14971:2007, USP<1663> and USP<1664>), are limited with LC/UV. Often, LC/MS provides the only practical analytical avenue for chemical identification of ppm level L&E analytes.
This case study highlights the analytical power of “accurate mass” mass spectrometry in the chemical identification of an unknown, ppm-level analyte extracted from a long-term implantable (Class III) acrylic ophthalmic device. The LC/UV-PDA/QTof-MS instrument used in this study proved to be an effective “qual/quant” tool for this application. Click Here to Read Study