The Use of Expert Systems to Assess Genotoxic Impurities

The ICH published the first guidelines to address how impurities should be treated, although these contained no specific guidance on acceptable levels for 

Since the introduction of these guidelines, many pharmaceutical companies are now focussing more on establishing in silico results for their impurities before entering their NDAs and INDs into actual in vitro tests. 

Although individual companies each have their own, slightly different, working procedures, a generalised prioritisation strategy for impurities can be 

C/ass 11mpurities Impurities known to be both genotoxic (mutagenic) and carcinogenic. 

Class 2 impurities Impurities known to be genotoxic (mutagenic), but with unknown carcinogenic potential. 

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