The control of process related impurities and degradants is a critical step in the development of robust and scalable manufacturing processes. At AMRI, the monitoring of process related impurities or degradants is systematically accomplished utilizing LC – MS as a profiling technique. The identification of low level impurities from drug substances, drug product or metabolites is complemented by the isolation at small scale, enhancement studies via forced degradation or chemical derivatization.
AMRI routinely develops suitable 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, advanced spectroscopic techniques such as nuclear magnetic resonance (NMR), mass spectrometry (MS), raman, infrared (FTIR) and ultra-violet (UV) are utilized directly or in conjunction with capillary NMR and hyphenated techniques such as LC – MS/MS, Accurate Mass, and LC – NMR to expertly and efficiently identify 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 (link to chemical purification). Relative response factors are also determined based on rigorous analytical testing.