Characterisation of non-compendial reference standards for impurities: How good is good enough?
Presenter: Dr. Bernard A. Olsen, Olsen Pharmaceutical Consulting, LLC
Released: 28 June and 5 July 2018 You couldn't make this webinar? Watch the presentation on-demand!
For the characterisation of primary reference standards for active pharmaceutical ingredients (API) numerous suggestions are available already. However, for reference standards for impurities, information and guidance from the ICH and European Pharmacopoeia is less easily at hand, and less detailed. National regulation authorities also do not provide further guidance on the topic.
Not surprisingly, therefore, approaches to impurity standards are as manifold as possible, from both manufacturers of such standards and users as well. This webinar explains the different approaches to impurity reference standards. The focus is on analytical characterisation, and on the question of which level of characterisation is good enough for the corresponding purpose. The webinar will also point out the risks connected to the quantitative use of an impurity reference standard, which from its characterisation might be more suitable for a qualitative use only.