Stability Investigation of Test and Reference Standard Solutions
- Thursday
- November
- 13
- 2025
Joachim Ermer Overview:
The stability of reagents, sample and reference standard solutions is an important aspect to ensure an accurate and reliable analytical result (CFR, EU GMP-Guide). Therefore shelf-life and storage conditions must be defined to guarantee appropriate stability. For sample and reference standard solutions used for quantitative purpose, stability investigations are expected as part of the robustness investigation of the analytical procedure, as discussed in the new ICH Q2(R2) Guideline “Validation of Analytical Procedures”, and in the USP chapter <1226> “Verification of compendial procedures”.
Why you should Attend:
The Webinar provides recommendations with respect to stability investigations of test solutions for quantitative use. Suitable stability study designs, data calculations and assessments will be presented, in order to achieve a reliable and traceable shelf-life determination.
Areas Covered in the Session:
- Regulatory background (ICH Q2(R2), USP <1226>, FDA Validation Guidance)
- What changes are acceptable?
- Appropriate evaluation of stability results. Why is the assessment of individual results not suitable?
- Appropriate evaluation of stability data by averaging and regression
- Determination of the shelf-life of standard and sample solutions
Who Will Benefit:
- Analysts
- Lab Supervisors and Managers in Analytical Development
- Quality Control
- Quality Assurance
- Regulatory Functions Responsible to Develop, Optimize, Establish, Validate or Evaluate Analytical Procedures
Speaker Profile
Dr. Joachim Ermer is a biochemist with 30 years of experience in pharmaceutical analytics, including development products at Hoechst AG, global responsibilities as Director of Analytical Processes and Technology at Aventis, and head of Quality Control and head of QC Lifecycle Management Frankfurt Chemistry at Sanofi. From 2010 till 2020, he was also responsible for the central reference standard group and Global Reference Standard Coordinator of Sanofi. Since December 2020, he serves as consultant for topics of pharmaceutical analytics and Quality Control. Joachim Ermer is member of the USP Expert Committee “Measurement and Data Quality“, of the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and Advisory Board member of the ECA Analytical Quality Control Group.
He authored more than 60 publications on analytical topics and contributed to the USP General Information Chapter <1220> as well as other Stimuli Articles. He is editor and author of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005, 2015, 2024).