Ensuring drug quality: mastering stability testing in pharma
Watch this webinar to discover how UV-Vis spectroscopy and gas chromatography support API monitoring, testing and analysis.
Following publication of World Health Organization (WHO) guidance on stability studies for active pharmaceutical ingredients (APIs) in 2009, subsequent industry developments spurred revision of the text in 2018.
Degradation of APIs or finished products can reduce potency and/or therapeutic effect.
Stability studies assess how the quality of an active substance or finished product varies over time based on numerous environmental factors, including temperature, humidity and light. The data provide appropriate timelines for re-testing active substances or determining the recommended shelf life of a finished product.
Critically, these assessments can help identify potential degradation pathways in APIs, monitor changes in content and confirm that products continue to meet regulatory and therapeutic requirements until their expiry date.
Another issue is residual solvents not being fully removed during drying. Even trace levels (ppm) can significantly compromise the stability of a finished drug product.
Watch this webinar on demand to discover how technologies such as UV-Vis spectroscopy and Headspace-GC can help determine degradation and residual solvents.
Key learning points:
- Explore the vital role stability testing has in safeguarding product quality and patient safety
- Learn about utilising UV-Vis spectroscopy in monitoring API concentration and dissolution testing
- Find out how gas chromatography supports residual solvent testing and regulatory compliance.