Introduction of Enhanced Ames Test (EAT)

We started offering Enhanced Ames Test (EAT) from this fiscal year.
Ames test is one of the methods to evaluate cytotoxicity. However, it is known that nitrosamines typically show negative results under standard Ames test conditions.
The EAT, which can sensitively detect the mutagenicity of N-nitrosamines, is one of the risk assessment methods for nitrosamine impurities. This method is stated in 'Nitrosamine Impurities: Guidance for Marketing Authorisation Holders' (European Medicines Agency) and 'Control of Nitrosamine Impurities in Human Drugs' (FDA).