Identification and Control of Pseudo Degradation Products during Stress Testing on Drugs

Authors: Singh S, Singh DK
Publication: Spinco Biotech
Software: ADMET Predictor®


This short note discusses a few examples of pseudo DPs observed by us or by other authors. The purpose is to highlight the nature of unwanted reactions that can occur during stress studies. The peaks of pseudo DPs unnecessarily cluster the chromatogram, and hence expectedly are not encouraged by industry users. Towards that objective, a protocol is proposed, which can be included in the stress testing sample preparation plan, so that formation of pseudo DPs can be avoided at the origin, leading to cleaner stability-indicating LC methods.