Abstract

Systematic approach for identifying, characterizing and evaluation Impurities and degradents

K K Bhagchandani, Senior Director, Advanced Chemistry Development Inc

Pharma industry produces one of the purest and safe chemical compounds for a long time, however they are highly regulated to ensure this keeps happening. All these companies are hence working with Impurities and Degradents as a habit. However, this task is not as easy as it sounds! they are required to work on it in detail and generate all the necessary information involving several analytical and biological experiments. This is not only time consuming but very laborious as well. This presentation is about how with a systematic and unified approach at these R&Ds we can save time in identifying, characterizing and evaluating Impurities and degradents; we will be discussing how the new technology can help them 1.In comparing data from different datasets to establish that there is something unwanted, 2.Design and generate methods to separate them over HPLC 3.Characterize completely the unknown with NMR & MS 4.Evaluate if this is a potentially genotoxic impurity or not. 5.Create a knowledge pool so that redundancy is removed and re-invention is prevented