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Abstract
Introduction. In case of methods of impurities determination quite often there are problems connected both with establishment and with check of implementation of the requirement to necessary sensitivity of a chromatographic system. Text. Influence of correction factors and late eluting peaks of impurities on the requirement for the signal-to-noise ratio (S/N) for chromatographic system suitability testing is considered. Conclusion. The recommendations are provided how to detect situations at which the requirement of S/N≥10 is insufficient for reliable detecting peaks of all impurities (related substances) and therewith how to correct concentration of test solution and/or the requirement to S/N for system suitability testing.
Highlights
In case of methods of impurities determination quite often there are problems connected both with establishment and with check of implementation of the requirement to necessary sensitivity of a chromatographic system
The recommendations are provided how to detect situations at which the requirement of signal-to-noise ratio (S/N)≥10 is insufficient for reliable detecting peaks of all impurities and therewith how to correct concentration of test solution and/or the requirement to S/N for system suitability testing
Цель статьи: в дополнение к [5] рассмотреть ситуации, при которых нижняя граница требования S/N≥10, то есть 10, может оказаться недостаточно большой для надежного детектирования пиков примесей; дать рекомендации, как обнаружить такие ситуации и при этом как скорректировать концентрацию испытуемого раствора и/или требование к отношению S/N для пика основного вещества на хроматограмме раствора проверки чувствительности хроматографической системы (ПЧХС)
Summary
In case of methods of impurities determination quite often there are problems connected both with establishment and with check of implementation of the requirement to necessary sensitivity of a chromatographic system. Опубликованным в [2,3,4], концентрация раствора для проверки чувствительности хроматографической системы (ПЧХС) должна соответствовать порогу игнорирования примесей (disregard limit; чаще всего 0,05%), а отношение сигнал/шум (S/N), рассчитанное для пика основного вещества на хроматограмме раствора ПЧХС, должно быть не меньше 10 [2,3,4].
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