|dc.description.abstract||"High performance liquid chromatography-mass spectrometry (HPLC-MS) is an analytical technique used for many applications in many different stages of drug development including in vivo drug screening, metabolic stability screening, metabolite identification, impurity identification, degradant identification, quantitative bioanalysis, and quality control etc.
This image, acquired in mechanistic studies of drug degradation, shows mass spectrometric monitoring of secondary degradation of a drug. In pharmaceutical manufacturing finishing line, vials are inspected by leak detection system. High voltage electric current is applied to glass vials, producing trace amount of ozone. In this particular case, drug, in aqueous solution, undergoes ozonolysis to form degradant #1, and further, in neutral or slight basic pH condition, amide bond breaks to give secondary degradant #2. HPLC-MS technique is sensitive and specific enough to detect small amount of degradation products and give structural information of degradant, facilitating mechanistic investigation during drug development."||en