Recently published guidelines from e.g. USP, Eurachem/CITAC, ICH and ISO demonstrate that the principles of Quality by Design (QbD), which are frequently in the pharmaceutical and biopharmaceutical industries to drive process development and manufacturing, are becoming more and more applicable for the development of analytical methods as well. This enables a clearly understood dependency on variables that are capable of influencing the method, and also a quantitative understanding of the method’s performance (e.g. accuracy and precision).
Here, we describe the application of QbD principles to the development and assessment of quantitative NMR methods to determine the potency of APIs. New test designs will be presented that can be used to asses the uniformity of the excitation over a given spectral range as well as the linearity of the receiver response.
