Reactivity of N terminal histidine of peptides towards excipients/impurity of excipients: A case study of liraglutide excipient compatibility study.

The selection of quality excipients is a crucial step in peptide formulation development. Apart from excipient incompatibility, process-related impurities or degradants of an excipient can interact with peptide-active pharmaceutical ingredients, forming the interaction products. The formaldehyde has been reported as an impurity of excipient in polyethylene glycol, glycerol, magnesium stearate, microcrystalline cellulose, mannitol, etc.

Hyphenated liquid chromatography - diode array detection - charged aerosol detection - high resolution - multistage mass spectrometry with online hydrogen/deuterium exchange: One stop solution for pharmaceutical impurity profiling.

Hyphenation of different analytical techniques has always been advantageous in structural characterization as it saves time, money and resources. In the pharmaceutical sector, chromatography-based impurity profiling, including identification, characterization, and quantification in drug substances or finished products, is of utmost importance to comply with quality, patient safety and regulatory requirements. These impurities are monitored using LC-UV/DAD and identified and/or characterized using HRMS and MS/MS.