In any N-Nitrosamine risk assessment it is critical that analytical data used in such assessments is accurate. Without this it is impossible to determine the extent of the risk or indeed to resolve any issues that threaten the viability of the product concerned. This may seem like an obvious statement and true of any investigation into impurities. However, the challenge posed by Nitrosamines in terms of their analysis is uniquely challenging, factors such as extreme low levels, artefactual formation all contribute to uncertainty.
This presentation looks at such challenges and examine the potential to develop a systematic approach to method development and validation, both in terms of simple N-Nitrosamines and Nitrosamine Drug Substance related impurities (NDSRIs).