The MTS consultant, Oona McPolin, will deliver a presentation entitled, ‘Challenges in Development and Validation of Stability Indicating Methodology‘ at the JPAG symposium, ‘Stability VI’ on the 30th June 2022, which will be held at the Royal Society of Chemistry in Burlington House, London. If you are interested in the analytical methodology used for supporting […]
Category: Stability
How Much Forced Degradation in a Stress Study?
When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for?
What is Mass Balance in a Forced Degradation Study?
What is the ‘mass balance’ for an analytical method and is it critical that I investigate it as part of method development or method validation?