Residual impurities resulting from manufacturing, formulation or degradation of the active pharmaceutical ingredient (API) and excipients, may be present in pharmaceutical products. Some of these impurities may show a potential for genotoxicity and therefore pose an additional safety concern. Since the turn of the millennium, the subject of genotoxic impurities (GIs) has been one of the most emotive issues facing the industry. GIs have now equal significance in terms of both, safety and quality, and are of increasing interest to regulatory agencies and industry scientists. Although some guidelines were pubished, there are still concerns and uncertainty due to the complexity of the issue. A proactive, multidisciplinary approach is needed to assess potential for GIs to affect the quality of API.

In this presentation the most important aspects relating to GIs will be described, like: interpretation of regulatory guidelines, determination of acceptable limits for such impurities in active substances, test methods used to qualify potential GIs, using of structure-activity relationship (SAR) and alerting structure concept in assessment of potential GIs. Examples of compounds known to be GIs as well as analytical methods used for their determination will be also covered.

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