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Ultrafast Workflow for ICH Linearity Studies

According to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), it is necessary to test analytical methods for their linearity as part of a method validation study. The typical process for this is to prepare standards for 5 different calibration levels, and to make triplicate injections of each of these standards. The concentration range used is typically 70-130% of the nominal concentration. Statistically it is recommended that each concentration level is prepared individually. This has the effect of randomizing potential sources of error (e.g. a possible incorrect weighing for one of the standards). However, this is typically not done as it is a time consuming process. Instead, many laboratories prepare a stock solution, and then dilute this down to the 5 different concentration levels. This has the benefit of being the fastest way of preparing standards, but has a major disadvantage: any error in the stock solution will be carried through to the diluted standards.

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  • Mettler Toledo
  • validation
  • HPLC

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