AMRI expertly conducts separation services within all phases of the drug development process. Purification of materials of interest such as APIs, intermediates, impurities or degradants of key targets are routinely performed on gram to kilogram scale.
AMRI conducts feasibility studies which include method development, component correlation between methods, target confirmation by LC – MS, method optimization, loading study and stability assessments of the isolates during each stage.
AMRI employs SFC as a complementary chromatographic tool for compounds or mixtures at the appropriate polarity range. SFC provides the advantages of green technology and quicker isolation time. Upon completion of the feasibility studies, AMRI scales-up the process for the purification of the target components on HPLC, LPLC or SFC depending on drug development phase and manufacturing stage. AMRI’s in-house inventory of chromatography media for preparative applications (chiral and achiral) provides an advantage for extensive screening purposes as well as quicker turnaround on the processes. Materials of interest, including controlled and potent compounds, are routinely isolated through classic and chromatographic techniques.