Losartan azide impurity confirmed as not an in vivo mutagen compound

[Yosukemino]

Hi, @MonazBmysorewala.

@conudel explained details on it in another topic. I think it is helpful to you.

Sufficient AMES test, parameters

Indeed Losartan Azide has been determined to be nonmutagenic in the in vivo comet assay after it was positive in the Ames test. This has now been confirmed also by CMDh and it is now accepted as a Class 5 impurity that can be controlled in accordance with ICH Q3A/B. However, this is true for the azido impurity and currently this method is not accepted for nitrosamines by the health authorities. Namely, the comet assay is not considered by the HAs as a valid test for nitrosamines, and currently …