SMALL MOLECULE QUANTITATION USING UPLC-MS/MS
LC-MS/MS is the method of choice to quantitate ionizable low molecular weight “small molecule” drugs. QPS has significant experience with various chemical structures in multiple therapeutic areas. With the increasing emphasis on “active” metabolites, “active” isomers, pro-drug, and the 505(b)(2) regulatory pathway, over 50% of our new chemical entity (NCE) studies utilize an “N in 1” format and about 5% of our new assays include chiral separation.
QPS currently has 70+ LC-MS/MS or LC-QTRAP or LC-HRMS instruments dedicated to regulated, non-regulated, discovery, and metabolite identification studies. Coupled with state-of-the-art UPLC systems, QPS is able to achieve excellent chromatographic separation with minimal cycle time at low detection limits – often, at the picogram level. This approach allows us to support a variety of studies, including rapid turnaround for dose escalation decisions.