Abstract

Forced Degradation Products: Their Relevance and Identification/Characterization

Saranjit Singh, Professor/Head, NIPER Mohali

Degradation products must be controlled in pharmaceuticals below stringent threshold levels that have been prescribed by regulatory agencies and the compendia. This is to be done in both APIs and finished pharmaceutical products. Otherwise there are chances of their recall from the market, and several instances already exist of the same. Usually, the degradation products need to be characterized whenever they are = 0.1%. The conventional approach followed is enrichment, followed by spectral analysis. However, these days, extensive use is made of sophisticated hyphenated techniques, including LC-MS and LC-NMR, as these allow characterization of minor components at the level they are actually present in API or the formulation. Some of the labs also possess LC-IR instrument, which has also been used to obtain structural information. The presentation will discuss the relevance and importance of degradation products in pharmaceutical substances and products. It will highlight a strategy for the characterization of degradation products involving use of hyphenated LC-MS, LC-NMR and LC-IR techniques. The same will be duly explained through multiple case studies from our lab and the literature.