Manufacturing & Analytical Characterization
Paulina Pinedo-Gonzalez, PhD
Chemist
SGS Health Science
Fairfield, New Jersey
Simon Szwandt, PhD (he/him/his)
Senior Field Scientist
Thermo Fisher Scientific
Warrington, England, United Kingdom
Description: Working closely with the industry to understand day-to-day problems allows us to achieve practical solutions to enhance the potential of bringing a drug to market. In E&L analysis, the combination of three detection techniques; CAD, UV and HRAM-MS, gives confidence in the semi-quantitation of unknown extractables. For nitrosamine analysis, automation mitigates many established false-positive risks like contamination and artefactual formation. The development of a single sample preparation for LC-MS and GC-MS enables orthogonal confirmation.