In all cases of new/increased levels of impurities, need: toxicology (Q)SAR analysis, if a reliable prediction is possible and can be supported scientifically. If there is an SAR alert for the impurity, it should be considered if this alert is also present in the active substance (and hence whether the potential concern is addressed by studies on the active substance). It might be considered appropriate to having a closer look at the alert and the structure triggering the alert or to investigate further to determine the validity of the alert in this particular case, e.g., by conducting a study.
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