External reference standards or relative response factors: some considerations
Presenter: Dr. Bernard A. Olsen, Olsen Pharmaceutical Consulting, LLC
Released: 2 October 2018 You couldn't make this webinar? Watch the presentation on-demand!
Organic impurity levels can be measured by a variety of techniques, including those that compare an analytical response for an impurity to that of an appropriate reference standard or to the response of the new drug substance itself. In cases where the response factors of the drug substance and the relevant impurity are not close, this practice can still be appropriate, provided a correction factor is applied or the impurities are, in fact, being overestimated.
In this webinar we look at the rationale for using RRFs and potential errors in RRF determination, including robustness and salt form issues, as well as the impact an incorrect RRF can have.