For many years it has been known that Pharmaceutical Elastomers are the potential source of the existence of nitrosamines in Drug Products. With the recent regulatory spotlight on nitrosamines, other Pharmaceutical packaging constituents came into the picture.
In this webinar case studies will be presented where Extractables screening of primary and secondary packaging materials could assist in the risk evaluation/assessment for the presence of nitrosamines in the related Drug Products. Case studies of Leachables screening in Drug Products will be presented to demonstrate their assistance in the risk evaluation/assessment for the presence of nitrosamines in the concerned Drug Products.
In the subsequent confirmatory testing steps, the following questions need to be answered: are the predicted nitrosamines actually present in the final Drug Product and, if so, do they exceed the acceptable intake limit as listed in the relevant regulatory guidelines? Analytical challenges for monitoring Nitrosamines in final Drug Products will be discussed by means of case studies. In this discussion the focus will be on liquid Drug Products with very high maximum daily doses.