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Comparative Evaluation of Different Plating Methodologies and Sources of Induced S9 Metabolic Activation on the Mutagenic Potential of N-Nitrosodipropylamine Using the Ames Test

Safety Assessment Genetic toxicology

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Comparative-Evaluation-of-Different-Plating-Methodologies-and-Sources-of-Induced-S9-Metabolic-Activation-on-the-Mutagenic-Potential-of-N-Nitrosodipropylamine-Using-the-Ames-Test

 

Presented at SOT 2023

Due to the current FDA concern and guidance on reducing the risk of Nitrosamine impurities in human drugs, there has been an increased industry need for testing of these impurities using the Bacterial Reverse Mutation (Ames) test. As Nitrosamines are not readily detectable by standard Ames methodologies, specifically cited in the Ames testing guideline (OECD 471), the need for a robust protocol better suited for this class of compounds is warranted.

Download your copy to:

  • Review the results of the modified Ames for nitrosamine testing compared to the results of the standard Ames design

  • Understand the limitations of the standard Ames assay in testing nitrosamines

  • Learn what additional investigations are needed for nitrosamine testing

 

 

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