Mutagenic Impurity Risk Assessment Purge Tool.pdf
For synthesis it is usually necessary to use very reactive compounds (e.g. electrophilic reagents used in alkylations). These are often inherently mutagenic and mutagenic impurities (MIs) can also be generated during a synthesis route. Due to their reactive nature however, many of these agents are unlikely to be present at the end of the process. Previously, Regulatory Authorities were reluctant to accept risk assessment based simply on chemical based arguments. A significant amount of effort has therefore been expended in many cases ‘to prove a negative’. The challenge is therefore to develop an approach that allows the likelihood of potential carryover of an MI to be assessed without exhaustive analytical testing. This presentation provides an overview on a project looking to develop such an approach.
Presented by Ella Smoraczewska at the 37th ICGM, Phoenix, USA; 27th March 2014.