Trace-level impurity analysis, such as genotoxic impurities (GTI) testing based on FDA/EMA guidelines, contaminants analysis for quality verification or purity and stability testing, can be difficult to perform using conventional UHPLC system.
However, the automatic i-DReC function enables the analysis of compounds at high concentration and at trace level within the same run. Typically, in order to analyse low level impurities using UHPLC system with a photodiode array detector, it is necessary to inject a high volume of sample. As a result, the high concentration of active/main ingredients saturates the detector signal and the information of its real concentration level is lost.
It is due to the fact that when analysing a high-concentration sample, a peak may exceed the dynamic range of detector and prevent a correct area value from being obtained. Signal saturation results in non-linear calibration plots. The additional run using diluted sample is then required. However, with Shimadzu’s i-DreC function, this issue is mitigated allowing for quantification of both low and high concentration analytes. The i-DRec automatically corrects the calibration curve in saturated areas and can, therefore, calculate the concentration of high-level compounds, while also analysing trace-level impurities in a single run.
The setting can be simply applied to routine analysis without the need of standard samples for correction.
The i-DReC essentially extends the calibration curve linearity of the detector, allowing for both low level impurities and saturated peaks to be simultaneously analysed in a single run, thereby increasing productivity and sample throughput.
For a more detailed explanation of the i-DReC function, click here.