From PharmTech: Detecting and Determining Quantitation Limits for Impurities

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In the Lab eNewsletter, Pharmaceutical Technology's In the Lab eNewsletter, December 2021, Volume 16, Issue 12

Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.

Regulations require drug manufacturers determine the detection limit (DL) and quantitation limit (QL) of impurities in APIs and drug products. There are multiple ways of doing so, some of which are described in the International Conference on Harmonisation (ICH) guideline, ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology. Primarily, these methods are based upon the statistical uncertainties from a linear least squares regression calibration curve. However, different calculation methods give different answers. The following describes an example and a recommended best practice method.

View the original article published in the November 2021 issue of Pharmaceutical Technology.


About the Author

Chris Burgess is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.