Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
On acceptable values of disregard limits for impurities and signal-to-noise ratio when checking chromatographic system sensitivity
Abstract
The article provides answers to urgent questions relating to the acceptable values of disregard limits for impurities and signal-to-noise ratio ( S / N ) when checking the sensitivity of the chromatographic system. It gives recommendations on the «typical» and maximum acceptable values of disregard limits for impurities. The article also demonstrates that the requirement of S / N ≥ 10 can be unnecessarily rigid in some cases: there could be found convincing arguments justifying a smaller S / N value for the sensitivity solution, for example, in cases when an identified impurity is determined by a specific procedure and the impurity peak appears before the peak of the main substance.
