Chemical Characterization Testing Services

Chemical characterization is a fundamental process used to identify and quantify the chemical constituents present in medical device materials, including any potential leachables (substances that may migrate during use) or extractables (substances that can be drawn out under laboratory conditions). This assessment provides detailed information about the material composition and is essential for evaluating potential toxicological risks associated with patient exposure.

The process typically involves analytical techniques such as gas chromatography, mass spectrometry, and Fourier-transform infrared spectroscopy (FTIR) to detect and measure both organic and inorganic compounds.

Chemical characterization is especially important for devices intended for long-term or internal use, where prolonged contact with body tissues or fluids may result in chemical migration. The data gathered supports biocompatibility assessments and regulatory submissions by ensuring that materials are safe, stable, and appropriate for their intended medical use, ultimately protecting patient health and safety.