To aid in the development of robust and scalable manufacturing processes, our scientists apply LC/MS as a profiling technique to systematically monitor process-related impurities and degradants.

We develop chromatographic and classic methods for the enhancement and isolation of critical impurities. Upon isolation of milligram quantities from the original source via HPLC or SFC, we use advanced spectroscopic techniques such as nuclear magnetic resonance (NMR), mass spectrometry (MS), Raman, infrared and ultraviolet. We apply these techniques directly or in conjunction with capillary NMR and hyphenated techniques such as LC/MS/MS, accurate mass and LC-NMR for fast, accurate identification of materials of interest.

Upon identification of the target impurity, AMRI offers scale-up processes for the isolation of gram quantities of impurities or degradants for use as reference materials. Relative response factors are also determined based on rigorous analytical testing.