Sollicitatievraag bij Curia

How do you know if an analytical method is stability-indicating?

Antwoorden op sollicitatievragen

Anoniem

16 mei 2016

Batches of Matrix/analyte tested initially then subjected to various temps. Samples from diff. conditions analyzed simultaneously and consecutively. depending on matrix, i.e. Animal feed- ambient, kept at constant higher than ambient temps (there is algorithm for specific temp in order to be able to extrapolate shelf life more quickly.) an analysis that indicates degradation will reflect Breakdown of analyte and perhaps also decomp products.

Anoniem

11 dec 2018

If a procedure is a validated quantitative analytical procedure that can detect changes in a quality attribute(s) of the drug substance and drug product during storage, it is considered a stability indicating test. "Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry"