Besides regulatory expectations, the Webinar provides recommendations with respect to stability investigations of test solutions for qualitative and quantitative use. Suitable stability study designs, data calculations and assessments will be presented, in order to achieve a reliable and traceable shelf-life Determination.
The following topics will be covered:
- Requirements to solutions for qualitative and quantitative use
- Correspondig addition to USP General Information Chapter “Verification of compendial procedures“ (valid December 1, 2019)
- What changes are acceptable for qualitative and quantitative use?
- Appropriate evaluation of stability results. Why is the assessment of individual results not suitable?
- Evaluation of stability data by averaging and regression
- Determination of the shelf-life of standard and sample solutions
Recording from 06.05.2020
Duration of recording: 1,5 h.