CPSA 2011

Science and Technology Coming Together to Make a Difference

October 3 - 6, 2011
Buscks County Sheraton Hotel
Langhorne, PA

Workshop Abstract

Tuesday, Afternoon Workshop

Analytical Challenges in Controlling Genotoxic Impurities

David Q. Liu, Mingjiang Sun, Alireza Kord
API Chemistry & Analysis-US, GlaxoSmithKline

The elimination of pharmaceutical impurities to produce highly pure drug substances is an important goal of process chemistry. One class of such impurities is potentially genotoxic so that regulatory agencies are increasingly concerned with their presence in drug substances and requiring manufacturers to deliver innovative approaches for their analysis and control. The need to control most genotoxic impurities in the low parts-per-million level relative to the active ingredient, combined with the often reactive and labile nature of genotoxic impurities, poses significant challenges on process development. From a quality-by-design perspective, product quality (genotoxic impurity controls in this case) should be built into the manufacturing process. This necessitates practical analysis and control strategies derived on the premise of in-depth process understanding; however, a general guidance on how to develop such strategies is currently lacking in the industry. In this presentation, real world examples on analysis and control of genotoxic impurities in the manufacturing process of drugs will be discussed aiming to stimulate discussions among the pharmaceutical scientists.

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