J-Star Research has recently established significant impurity isolation and structural elucidation capabilities. The R&D team is comprised of experts in identifying and characterizing low levels (e.g. 0.1%) of impurities in chemical intermediates and APIs. This is done by impurity enrichment from mother liquors, impurity isolation from process streams or by mass directed semi-preparative HPLC techniques, multinuclear and multidimensional NMR and LCMS, and HRMS by Orbitrap Elite Mass Spectrometer with MSn capabilities. In addition to structural elucidation, our team’s penchant for complete, unambiguous and robust NMR characterization, with access to four in-house NMRs, is adept at supporting your regulatory filings.
This group is co-anchored by Frank Rinaldi at our Cranbury NJ Research Center. Prior to joining J-Star, Frank spent 27 years at BMS as an NMR subject matter expert specializing in analytical strategies to solve process chemistry development issues, characterizing active catalysts and catalytic species and identifying low level impurities.
The lead mass spectrometrist is Junling Gao, who is also based at our Cranbury Research Center. Junling brings 20 years of experience from Schering-Plough Research Institute/Merck in structural elucidation supporting diverse drug discovery and development projects for structure elucidation by LC-HRMS/MS, HDX-HRMS/MS and quantitation of trace components in chemical or biological matrices by LC-MS/SIM or LC-MS/MRM.
The South Plainfield NJ Research Center’s NMR lead is Robert Reamer who is unparalleled in the field of NMR structural correlation. Bob is a 40-year veteran of the Merck Process Chemistry group where he supported >200 INDs and NDAs prior to joining J-Star.
Whether you need NMR and structural elucidation support in an early stage program, to support post filing activities, or somewhere in between, J-Star’s team of experts is poised to support and add significant value to your program.